€¦  · web viewthe winship phase 1 unit supports all emory clinical investigators including...

27

Click here to load reader

Upload: vunhan

Post on 25-May-2019

212 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

The Visiting International Clinical Researcher Training and Mentoring Program

Executive Summary. The American Society of Hematology (ASH) in conjunction with the Sociedad Española de Hematología y Hemoterapia (SEHH) and the Società Italiana di Ematologia (SIE) will conduct the Visiting International Clinical Research (VICR) training and mentorship program in lymphoma. ASH Staff invited Emory University and Dana Farber to pilot the feasibility study by hosting international fellows from Spain and Italy. Staff intend to invite two additional US institutions to also participate in the future. In partnership with the US institutions, ASH will create a review process to select up to four fellows (two from Italy and two from Spain) interested in conducting clinical training and clinical research training in lymphoma in the US for 1-2 years from the pool of applicants.

The selection criteria will include:

1. Applicant – Strength of the applicant and career development plan.2. Home Institution Mentor Relationship – Strength of the mentor's relationship with the

applicant, and the likelihood of consistent support, based on the mentor’s CV and the mentor’s letter of support.

3. Other Letters of Support – Strength of the other letters of support.4. Career Plans – Likelihood of the applicant's career development plans to lead to independent

investigation.5. Commitment – Applicant’s demonstrated commitment to lymphoma research and improving

lymphoma patient care and outcomes.6. Level of Benefit – Level of benefit the applicant will derive from this program.

Recognizing that mentorship is critical to a positive fellowship experience, ASH will provide a stipend ($5K per year) to each fellow’s host mentor in the US. At the end of the two-year pilot, ASH staff, participating US host institutions and mentors, and international partner societies would review outcomes of the program and propose next steps.

Background. Lymphoid malignancies are a complex and heterogeneous group of cancers with >80 subtypes of lymphoma included in the major categories of Hodgkin and non-Hodgkin lymphoma (NHL). Recently, Dr. Flowers and a group of investigators generated the first estimates of the total number of lymphoid malignancy cases in the U.S, stratified by World Health Organization classification subtype along with detailed incidence and survival statistics. Collectively, lymphoid neoplasms are the fourth most common cancer and the sixth leading cause of cancer death in the United States with 136,960 new lymphoid neoplasms projected to occur annually. Establishing a comprehensive strategy to meet the needs of these cancer patients requires: 1) detailed data on U.S. incidence rates and survival across this heterogeneous group of cancer patients (which has recently been completed); 2) an infrastructure to support clinical and basic research to understand factors that influence prognosis and survivorship [which was recently developed through the NCI-funded Lymphoma Epidemiology of Outcomes Cohort Study (NCT #02736357; U01CA195568) co-led by Dr. Flowers]; and 3) a well-trained workforce of clinical investigators who can use this infrastructure and other resources to examine and address the needs of this patient population.

Oncology Workforce. According to the Association of American Medical Colleges (AAMC), in 1971 there were approximately 3 million cancer survivors in the United States. By 2001, the number of survivors had increased to nearly 10 million. Given that the number of cancer survivors likely will continue to increase, there will be a corresponding increase in demand for

Page 2: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

well-trained clinical oncologists. According to the same report, since more than half of the currently practicing oncologists are over the age of 50, the majority of the current oncologists will be 65 or older by the year 2020. At present, the number of fellowship training programs is not expected to increase to meet these demands, and in particular will fail to meet the needs for specialized cancer care. More well-trained, young professionals are needed to meet future demands for the field and the increasing need for subspecialty training to keep up with advances in medical science and clinical practice in fields such as lymphoma.

Clinical Research Mentorship. Having an experienced professional as a mentor can often inspire younger mentees to pursue careers in clinical research, provide encouragement for the mentee to seek out leadership roles, and is associated with greater career satisfaction. Studies have shown that fostering such relationships benefits the mentors, influencing academic productivity and career advancement. However, access to a helpful mentor is not enough to fully prepare young investigators. Research shows that in addition to technical training and mentor/mentee relationships, education about career development, leadership, and management of work-life balance as well as other professional challenges is necessary for young professionals to be fully prepared for a career in academic research. As such, prominent oncology societies support well-rounded training programs to help early career professionals prepare for success. This strategy is employed by prominent oncology associations, including the American Society of Clinical Oncology (ASCO)/American Association for Cancer Research (AACR) Methods in Clinical Cancer Research workshop and the Lymphoma Research Foundation Clinical Research Mentoring Program (LRF CRMP). Our faculty have trained and served as faculty and mentors for each of these programs.

Evaluation. Clinical research training and mentoring programs have been proven to benefit from thorough program evaluation. Tracking program participants as they progress in their careers is essential to examining how participants fare in the long-term. This includes tracking future funding awards, career advancements, and research productivity (e.g., publications). In addition to tracking such achievements, assessing the skills and abilities gained from program participation is a vital indicator of program success. The construct of self-efficacy, which stems from social cognitive theory, refers to belief in one’s own ability to perform certain tasks, and studies show that a high sense of self-efficacy is essential to students’ application of knowledge into practice. Increased self-efficacy has been shown to improve individuals’ perseverance in performing work-related duties and their decision making by helping the learners recognize their potential skills. Self-efficacy arises from four main sources: personal experiences and achievements, visual experiences, verbal persuasions, and biological and psychological conditions, with personal experiences being the strongest of these components. Research self-efficacy involves an individual’s judgment of his or her abilities to organize and conduct meaningful research in various formats. A prior study evaluated 125 graduate students using instruments to measure of self-efficacy in research, the research training environment, and productivity. This study identified significant positive relationships between research self-efficacy and the research training environment, and between self-efficacy and research productivity. To enhance the VICR, we wish to incorporate evaluation metrics to strengthen the program and improve participants’ research self-efficacy and long-term research productivity.

There is only one other clinical mentoring and training program specifically designed for early career clinicians with an interest in research on lymphoid malignancies, the LRF CRMP. Our faculty member Dr. Blum developed and founded the LRF CRMP in 2014. Drs. Blum, Cohen, and Flowers have served as faculty in the program, and Drs. Blum and Flowers have served as co-Directors of the program in the past. However, LRF CRMP only supports Scholars from North America. The goal of VICR is to address the recognized gaps described above and implement solutions that address the needs of the community of physicians in Spain and Italy for

Page 3: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

specialized clinical and clinical research training in lymphoma. The proposed program expansion is needed to diversify the pool of lymphoma researchers, implement evaluation strategies, and to bolster the continued mentorship, skills development, and evaluation of Scholars to achieve long term objectives.

VICR Program Overview. In concert with the SEHH and the SIE, the VICR Faculty will select 1-2 Scholars per year from Spain and Italy to visit to Emory and Harvard/Dana Farber for 1-2 years of clinical and clinical research training. The Scholars will attend an initial 4-day workshop and two follow-up training meetings over the program. The VICR Program will convene a faculty of experts at the forefront of innovative lymphoma clinical research who will share their experience and knowledge throughout the program with the Scholars, both as a group and in small breakout groups. Faculty will not only mentor Scholars at the workshop, but also will be selected by the Scholars to become external longitudinal mentors. In addition, a few additional faculty with specific expertise will be identified to attend at least a portion of the program to present selected topics in the didactic sessions based on common themes occurring in the clinical studies of the workshop Scholars (e.g. genomic correlatives, novel biomarkers, patient reported outcomes).

In addition to attending the didactic sessions, the initial workshop also will involve the Scholars presenting their proposed clinical research projects, working with faculty (including a biostatistician) in a small group to revise their proposed clinical studies, and developing Specific Aims for a future grant submission. Scholars will present the revised protocol and Specific Aims of a future grant at the completion of the workshop.

Institutional Commitment and Infrastructure for Clinical Research Training and Career Development at Emory. The VICR Program will benefit from the abundant clinical research resources available to early-career faculty across the health science center. Woodruff Health Sciences Center (WHSC) has 7 components: Emory Healthcare, the most comprehensive health system in Georgia, including 10 healthcare facilities and the Emory Healthcare Network; Emory School of Medicine; Nell Hodgson Woodruff School of Nursing; Rollins School of Public Health; Yerkes National Primate Research Center; Emory Global Health Institute; and Winship Cancer Institute. WHSC has 24,649 employees (including 3,205 faculty),1,274 affiliated faculty, and 5,458 students/Scholars. Emory Healthcare has 2,046 beds receiving 72,832 hospital admissions and 4.5 million outpatient visits annually. Winship Cancer Institute of Emory University is Georgia's first and only NCI-designated Comprehensive Cancer Center. Winship provides the commitment and environmental capacity to support the clinical research, mentorship, administrative, and evaluation components of this program. Winship is dedicated to the integration of innovative clinical and basic science research with outstanding patient care for the prevention, treatment, and control of cancer. Winship was founded in 1937. In 1937, Winship treated 168 patients; currently, Winship clinicians see >17,000 patients annually at 7 sites: Emory University Hospital, Emory University Hospital Midtown, Emory Saint Joseph's Hospital, Emory Johns Creek Hospital, Grady Memorial Hospital, the Atlanta VA, and Aflac Cancer and Blood Disorders Center at Children's Healthcare of Atlanta. Emory Healthcare facilities use a common electronic health record system. Clinical, pathology, pharmacy, laboratory, claims, and other electronic data are stored in the Emory Clinical Data Warehouse (CDW), a repository that integrates data from multiple business and clinical applications across Emory Healthcare – providing data for clinical quality reporting and research. Efforts are underway by Winship Research Informatics to integrate CDW and hospital cancer registry data to establish a cancer DataMart. Additional clinical data resources available to Emory investigators include: the OnCore clinical trials management system, the OpenSpecimen tissue and biobanking data system, and participation in the Oncology Research Information Exchange Network (ORIEN) and ORIEN Avatar Research Program, an alliance to integrate

Page 4: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

clinical, molecular, and sequencing data and sample collection using a common protocol to promote collaboration and accelerate cancer research and care. Winship has ~450 faculty including investigators in the schools of medicine, public health, and nursing, Emory College, Georgia Institute of Technology (Georgia Tech) and partner institutions. Winship faculty collaborate with professionals from around the world and with national and state agencies, including the Centers for Disease Control (CDC), American Cancer Society (ACS), and Georgia Research Alliance. Winship investigators conducted >250 therapeutic clinical trials and enrolled more than>750 patients on therapeutic trials in 2017. Winship is one of 30 US cancer centers selected as a Lead Academic Participating Site for the National Clinical Trials Network in 2014 (PI: Ramalingam). Winship has the largest unit in Georgia for phase 1 clinical trials. The Winship Phase 1 program facilitates opening trials rapidly to offer novel treatments to patients, advance science and technology developed at Emory, and conduct trials in a safe, welcoming environment. The Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc Scholars; it annually enrolls >200 patients on trials across a variety of cancer types representing the diversity of region; ≥20% of patients enrolled are African-American. With the expected opening of a new 7500-sq. ft Oncology Phase 1 Unit in 2019, Winship is poised to become a national leader in early phase drug development. Winship has 4 research programs (Cancer Cell Biology, Discovery and Developmental Therapeutics, Cancer Genetics and Epigenetics and Cancer Prevention and Control) and 8 shared resources (Biostatistics, Animal Models, Genetics, Proteomics, Cellular Imaging, Pathology, Research Informatics, and the Intervention Development, Dissemination, and Implementation). Dr. Flowers is Scientific Director for the Research Informatics Shared Resource. The Georgia Clinical & Translational Science Alliance (GACTSA) of Emory University and partners Morehouse School of Medicine (MSM), Georgia Tech, and the University of Georgia (UGA) is a member of a national consortium striving to improve the way biomedical research is conducted. The consortium, funded through the (CTSA), shares a common vision to translate laboratory discoveries into treatments for patients, engage communities in clinical research efforts, and train the next generation of clinical investigators. The GACTSA's Research Education program focuses on long-term didactic and mentored clinical and translational research training. The program provides clinical and translational research training opportunities including the Master of Science in Clinical Research (MSCR) degree and a Certificate Program in Translational Research.

VICR Program Leadership. The VICR Program will be led by co-Directors Dr. Christopher Flowers (Emory) and Dr. Ann LaCasce (Dana Farber). Drs. Flowers and LaCasce are committed to improving the lymphoma research community and will be involved with the program development and participant selection. Drs. Flowers and LaCasce are exemplary mentors and ideal leaders for attaining a successful program. During the months preceding the selection of Scholars, at the selection of faculty and curriculum, and at the time of annual review, the co-Directors and faculty will have biweekly meetings to coordinate efforts and review progress towards the goal of the program. Teleconference calls will occur monthly in other months. Face-to-face meetings between the co-Directors will occur at least twice annually at Emory or other national/international meetings (e.g. ASH, ASCO, Lugano).

Dr. Flowers will be responsible for submission of the annual progress report to ASH and all communication with the ASH staff. Drs. Flowers and LaCasce will lead the portions of the program related to faculty selection, faculty outreach, and outreach and coordination with hematology/oncology fellowship programs at each of their respective sites. Drs. Flowers and LaCasce will co-lead the evaluation of Scholars and oversee the progress of the program toward achieving its goals.

Page 5: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

Dr. Flowers is the contact co-Director and will serve as administrative manager. He will assume overall fiscal administration and communication with the ASH staff. With input from Dr. LaCasce and the VICR Faculty, he will prepare and submit annual reports to ASH. The co-Directors and faculty will meet monthly to coordinate efforts, discuss issues of governance, administration and training, and can communicate by telephone or email as needed to address additional issues.

Emory VICR Program Leadership. Drs. Kristie Blum and Flowers will co-lead the Emory VICR site. Descriptions for the faculty members involved in the Emory Lymphoma VICR experience are included below.

Kristie Blum, MD. Dr. Blum is a Professor at Emory University. Dr. Blum directed the lymphoma clinical research program at OSU beginning in 2012, with oversight and management responsibilities of the clinical research program and clinical trials portfolio (includes a team of 1 senior nurse leader, 3 regulatory officers, 3 data managers, and 6 research nurses), management and distribution of Lymphoma Development Funding to support the research mission of the lymphoma group and development and management of a clinical lymphoma research database. The OSU lymphoma program sees over 400 new outpatients with lymphoma per year, with 3347 outpatient lymphoma visits annually. With respect to clinical trials, the lymphoma section has accrued 110 patients to lymphoma clinical trials in 2015 and currently has 26 accruing trials available exclusively for patients with HL or NHL, including Alliance studies, pharmaceutical-sponsored studies, and investigator-initiated trials, primarily as a result of her leadership and commitment to growth of the OSU clinical trials portfolio. With active participation in the Alliance and LRF, prior funding, a track record of publication, numerous mentees, and success in the expansion of the OSU clinical lymphoma research program, Dr. Blum has access to numerous collaborators that may benefit Scholars within the VICR.

Since 2005, Dr. Blum has served on the Lymphoma Core Committee for the Alliance (formerly Cancer and Leukemia Group B [CALGB]). She has had the opportunity to chair two CALGB studies in patients with NHL and HL: CALGB 50904, a randomized phase II trial of ofatumumab, bendamustine and bortezomib in patients with previously untreated follicular lymphoma and CALGB 50502, a completed trial of SGN-30 and GVD in patients with relapsed HL. She is also currently co-developing two new Alliance trials as a senior faculty mentor to Drs. Kami Maddocks and Frederick Lansigan at Dartmouth who are leading these studies.

Dr. Blum has extensive experience in the design, conduct, and publication of phase I-II trials, with focused interest in the clinical development of novel therapeutics for patients with aggressive B-cell NHL and Hodgkin lymphoma (HL). She has served as a principal investigator on several CTEP-sponsored phase I/II trials in patients with B-cell CLL and NHL, including 1) NCI 8046, a phase I trial of lenalidomide and flavopiridol in patients with relapsed CLL, 2) NCI 6997, a phase I trial of decitabine in patients with NHL, and 3) NCI 6520, a phase I trial of 17-AAG and bortezomib in patients with relapsed hematologic malignancies. In addition, Dr. Blum has had the opportunity to develop several investigator-initiated trials with industry support, including regimens exploring the efficacy of MLN 8237 (an aurora kinase inhibitor), BKM120 (a novel pan-P13 kinase inhibitor), ibrutinib (a BTK inhibitor) in combination with R-bendamustine, and combined panobinostat (an HDAC inhibitor) and lenalidomide in patients with relapsed or refractory NHL and HL. She has served as a principal investigator of several high-impact pharmaceutical trials, including trials with lenalidomide, ibrutinib, brentuximab, and idelalisib, that have led to FDA approvals of these agents in the treatment of patients with relapsed and refractory HL and NHL. As a result of these efforts, she was an author on 4 papers published in the New England Journal of Medicine between 2013 and 2014 regarding the use of ibrutinib and idelalisib in the treatment of CLL, mantle cell, and indolent NHL. Dr. Blum also has previously secured grant funding through NCI including a K23 NCI-funded career development in 2011

Page 6: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

entitled “Targeting Transcriptional Repression in CLL and NHL,” and an NCI-funded R21 Quick-Trials grant to support a trial with combined flavopiridol and lenalidomide in patients with relapsed CLL.

Dr. Blum also served as faculty for 3 years within the ASH Clinical Research Training Institute (CRTI), an intensive clinical research training course conducted by ASH annually with 20 Scholars that consists of a week-long intensive workshop on protocol development, conduct, publication, and grant funding as well as long-term early career mentoring for 1-3 years for the Scholars. She served as small group leader for CRTI, presented specific didactic content on drug development through CTEP, and has long-term mentoring relationships with several past participants. She is asked every year to come back and attend this program by the organizers. In 2013, Dr. Blum was nominated by the LRF Executive Committee to develop and chair a clinical research mentoring program for fellows and junior faculty devoted to lymphoma clinical research. The first program was held in February 2014, and was attended by 6 Scholars, consisting of fellows or junior faculty (within 3 years of their first faculty appointment), and over 20 faculty. Dr. Blum co-chaired the second LRF CRMP program in 2015 with Dr. Flowers, who continued to run this program through 2016.

In terms of her qualifications as a mentor and educator in the field of lymphoma research, Dr. Blum served as director of the Hematology/Oncology fellowship program at OSU from 2006-2013. During that time, she transformed a fellowship program of 14 fellows on ACGME probation into a nationally recognized training program with 25 fellows and a 5-year ACGME cycle length. In addition, over 50% of the fellowship graduates remained in academic medicine. Dr. Blum has directly mentored at least 9 clinical faculty and 10 fellows and is currently mentoring 3 faculty at OSU (Drs. Christian, Alinari, and Maddocks), 2 junior faculty at Emory and City of Hope (Drs. Cohen and Herrera), and 2 fellows (Drs. Maly and Bond). These mentees have successfully published and presented their works at national meetings (Dr. Alinari), received ASH Achievement Awards (Drs. Cohen and Alinari), and successfully competed for and received grant or foundation funding (Drs. Christian, Cohen, Alinari, and Maddocks). As a testament to her expertise as a clinical investigator and research mentor, Dr. Blum is currently funded through an NCI-K24 Mentored Patient Oriented Research Award entitled “Development of a Comprehensive Research Program in Mantle Cell Lymphoma in the Ibrutinib Era”.

Christopher Flowers, MD, MSc. Dr. Flowers is Professor of Hematology and Oncology at the Winship Cancer Institute at Emory University School of Medicine. Dr. Flowers has been Director of the Lymphoma Program at Emory University since 2006, with oversight and management responsibilities of the clinical research program, and has successfully developed several funded investigator-initiated studies. Until 2014, he led the Emory Lymphoma clinical trials. This portfolio includes >30 active clinical trials supported by a team of 2 regulatory officers, 2 data managers, and 6 research coordinators. The Emory lymphoma program sees over 400 new outpatient consults for lymphoma per year and provides >3000 patient visits annually.

Dr. Flowers has extensive experience in cancer epidemiology and outcomes research and in the design, conduct, and publication of phase I-II trials, with focused interest in the clinical development of novel therapeutics for patients with indolent and aggressive B-cell NHL. He has led several investigator-initiated early phase clinical trials and is now the global lead PI for an international industry-sponsored trial involving venetoclax, polatuzumab, and obinutuzumab, and the ECOG lead for a US Intergroup trial for relapsed follicular lymphoma. Under his leadership, the Emory lymphoma team has contributed to clinical trials that have led to high-impact publications and the FDA approval of six new therapies for lymphomas.

Dr. Flowers has successfully obtained substantial grant funding, both from societies and the NIH. He is a member of the lymphoma core committee at ECOG, has moderated and served as an

Page 7: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

expert discussant for oral abstract sessions at the ASH and ASCO annual meetings in lymphoma and health services research, and has a track record of high-impact publications in both fields. He was previously a PI of an NCI-R21 to study biologic variants underlying racial differences in diffuse large B-cell lymphoma and of an ASH/Robert Wood Johnson Foundation award to examine patterns of care and treatment preference for African American patients with NHL. He is currently the co-PI for an NCI-U01 funded project that established the Lymphoma Epidemiology of Outcomes (LEO) Cohort Study, which will assemble a cohort of >12,000 patients with NHL and collect clinical and epidemiological data, blood samples, construct a tumor tissue microarray, and extract host DNA and tumor tissue DNA and RNA for future analyses.

His training in clinical research methodology through the Robert Wood Clinical Scholars Program, the Stanford Medical Informatics program, and the University of Washington Pharmaceutical Outcomes Research and Policy Program have positioned him to teach this skill set to emerging clinical investigators. He honed these skills as a course director for 4 years for the Emory course, Population-based Outcomes Research (HPM 592A). He has also served as faculty within the ASH CRTI. He served as small group leader for CRTI and has long-term mentoring relationships with several past participants. He currently serves as a member of the ASH CRTI Oversight Committee. He has also met individually with Scholars at other national meetings for longitudinal mentorship.

Dr. Flowers has dedicated a significant portion of his career to training clinicians to pursue careers in cancer clinical research. His Scholars have published their mentored projects in numerous journals, including the Journal of Clinical Oncology and JAMA Oncology. He communicates at least yearly with nearly all of his former Scholars, tracks their ongoing progress, and is proud to note that several are developing productive careers in academic medicine. He has served as a research mentor for students involved in the Winship Summer Scholars high school program, the Emory medical student Discovery programs, and for several recipients of the ASH Minority Medical Student Award Program. In total, his institutional experience includes mentoring 17 high school students, 10 undergraduate students, 17 medical students, 13 hematology/oncology fellows, 8 other house staff, and 15 junior faculty members in patient-oriented research. Dr. Flowers received an NCI-K24 Mentored Patient Oriented Research Award that validates his expertise as a mentor in clinical research and will support some of his effort for the administration and management of the VICR program.

Thus, the leaders for the Emory Lymphoma VICR program are uniquely distinguished experts in lymphoma clinical research, clinical research methodology, and mentorship of early career investigators and are well poised to direct this program.

Emory VICR Clinical Training. The Lymphoma Clinical Care Training will involve observership in clinics and on the inpatient lymphoma/ multiple myeloma (OMA) service at Emory teaching facilities. In total, Emory Winship Cancer Institute has over 340,000 sq. ft. of devoted clinical space which includes clinical space at Grady Memorial Hospital and Emory St Joseph’s Hospital, where Scholars will also observe clinics. The clinics focus on specialized care for patients with lymphoid malignancies involving multi-specialty input from hematopathologists, immunologists, surgeons, radiation oncologists, and specialists in nuclear medicine and bone marrow transplantation. The clinics also focus on advances in clinical care like immunotherapy and CAR T-cells, specialized clinics in Cutaneous T-cell lymphoma (CTCL) and Adult Young Adolescent (AYA) patients, and clinical research. Each faculty member has a specialty clinic at least once a week. Each clinic consists of newly diagnosed patients, patients on clinical trials, as well as patients on follow up after receiving treatment and/or a Bone Marrow Transplant. Through the lymphoma clinics the Scholars will receive broad and detailed experience in the management of

Page 8: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

complex patients with a variety of lymphoid malignancies, exposure to novel therapeutics in clinical trials, and involvement in the care of advanced cellular therapies such as CAR T-cells. Scholars will also attend the weekly lymphoma clinical trial working group meetings in which new clinical as well as ongoing trials are discussed. Descriptions of the faculty clinics and clinical experiences, and an example of a monthly Lymphoma Clinical Rotation Schedule, are listed below.

Emory Faculty ClinicsChristopher Flowers, MD, MScDr. Flowers’ clinic at Emory University Clifton Campus (Wednesdays, 8:30 pm – 4:30 pm) focuses on specialized care for patients with all forms of lymphoid malignancies involving multi-specialty input from hematopathologists, immunologists, surgeons, radiation oncologists, and specialists in nuclear medicine and bone marrow transplantation. His clinic offers a variety of clinical trials and advanced treatment algorithms for patients with lymphoma including CAR T-cell therapy with a focus on the common B-cell malignancies: diffuse large B-cell lymphoma, follicular lymphoma, and small lymphocytic lymphoma/chronic lymphocytic leukemia. His current trials involve international and national studies in DLBCL and relapsed FL.

Kristie Blum, MDDr. Blum’s clinics at Emory St. Joseph’s Hospital (Mondays, 8:00 am – 2:00 pm) and Emory University Clifton Campus (Thursdays, 8:00 am – 2:00 pm) focus on specialized care for patients with B-cell non-Hodgkin’s and Hodgkin’s lymphoma. Treatment approaches in this clinic include observation, immunotherapy, chemoimmunotherapy, radiation, surgical resection, autologous bone marrow transplantation, or CAR T-cell infusion and are determined through a multi-disciplinary approach with collaboration with hematopathologists, surgical oncology, radiation oncology, and nuclear medicine. Clinical trials are also considered and offered to all eligible patients. Dr. Blum has extensive expertise and funding in the field of novel therapeutics, with a focus on the design and development of early phase 1 and 2 trials for patients with aggressive B-cell lymphomas including diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma, Burkitt lymphoma, and Hodgkin lymphoma. She is also developing an Adolescent and Young Adult lymphoma clinic, as many of the patients seen at these two locations are under the age of 40.

Jonathon Cohen, MD, MScJonathon B. Cohen, MD, MS, is board certified in hematology and medical oncology, treats Hodgkin and non-Hodgkin lymphoma patients, and is a member of the physician staff at the Bone Marrow and Stem Cell Transplant Center at Winship. Dr. Cohen is a leading expert in CAR T-cell therapy, an emerging new immunotherapy for some forms of lymphoma. Dr. Cohen has been recognized as a promising young investigator as evidenced by his selection to participate in the ASCO/AACR Methods in Clinical Cancer Research workshop, American Society of Hematology Clinical Research Training Institute, and the Lymphoma Research Foundation Clinical Research Mentorship Program.

Dr. Cohen runs clinics at Emory University Clifton Campus (Tuesdays, 8:00 am – 4:00 pm) and at the satellite clinic on the campus of Emory St. Joseph’s Hospital (Thursdays, 1:00 pm – 4:00 pm).  His clinic focuses on B-cell lymphomas and chronic lymphocytic leukemia and the management of patients across the disease spectrum. Our patients frequently participate in therapeutic clinical trials and he has a large portion of patients undergoing autologous or allogeneic transplantations as well as receiving CAR-T therapies. This exposure to such varied therapeutic maneuvers provides clinical experiences for learners that includes all aspects of care

Page 9: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

of patients with lymphoid malignancies. At the St. Joseph’s clinic, he encounters patients in a community setting with but with a close connection to the specialization available through Emory including access to clinical trials and cellular therapy interventions.

Jean Koff, MD, MScJean L. Koff, MD, MSc, is a clinical-translational investigator with a disease focus in lymphoma. Dr. Koff's academic focus is in epidemiology, outcomes, and translational research in lymphoma, with a particular interest in the intersection between autoimmune disorders and lymphoid malignancies. Dr. Koff's work has been published in many leading journals, including Cancer and Leukemia & Lymphoma, as well as presented at multiple international conferences. Dr. Koff has been recognized as a promising young investigator in lymphoma as evidenced by her selection to ASH Clinical Research Training Institute and receiving career development awards from the Lymphoma Research Foundation and the American Association for Cancer Research. Dr. Koff’s clinic at Emory University Clifton Campus (Fridays, 12:30 pm – 4:30pm) focuses on a variety of non-Hodgkin and Hodgkin lymphoma in her half-day clinic, with a special focus on autoimmune-associated B cell lymphomas, marginal zone lymphomas, and post-transplant lymphoproliferative disorders.

Pamela Allen, MD, MScPamela B. Allen, MD, MSc, is a clinical investigator with a focus on lymphoma and bone marrow and stem cell transplantation. Dr. Allen specializes in the treatment of Hodgkin lymphoma and T-cell lymphoid malignancies and treats patients at Winship Cancer Institute of Emory University. Dr. Allen has been recognized as a promising young investigator in lymphoma as evidenced by her selection to ASH CRTI and receiving awards from organizations include the Cutaneous T-cell Lymphoma Foundation. Dr. Allen’s clinic (Fridays, 8:30 am – 4:30 pm) consists of patients with B- and T-cell lymphomas, with an emphasis on cutaneous T-cell lymphomas. She provides specialized care focusing on clinical trials in newly diagnosed and relapsed Hodgkin lymphoma and T-cell lymphomas. She leads the lymphoma tumor board meeting and a CTCL-focused tumor board. She also engages in a multi-disciplinary clinic in CTCL with dermatologists and dermatopathologists.

Mary Jo Lechowicz, MDMary Jo Lechowicz, MD, is a clinical investigator in the Emory Bone Marrow and Stem Cell Transplant Center with a disease focus in lymphoma. Dr. Lechowicz's research focuses on novel therapies for Hodgkin lymphoma, HIV-related lymphomas, and cutaneous and peripheral T-cell lymphomas. Dr. Lechowicz has served as the primary investigator for >14 trials at Emory related to improvement of care in non-Hodgkin lymphomas, particularly related to transplantation; cutaneous and peripheral lymphomas; and HIV and lymphoma care. Dr. Lechowicz’s clinic (Thursdays, 8:30 am – 4:30 pm) consists of patients with B- and T-cell lymphomas. She provides specialized care with a focus on cutaneous T-cell lymphomas, other T-cell lymphomas, and rare lymphoid conditions such as Castleman’s disease. Dr. Lechowicz has been an Emory faculty member since 2003, has broad and diverse expertise in the management of lymphomas, and has been a leader in new drug development for these disease as a participant in multiple clinical trials leading to new drug approvals.

Leon Bernal-Mizrachi, MDLeon Bernal-Mizrachi, MD, is board-certified in medical oncology and a clinical member of the comprehensive care team treating lymphoma patients at Emory University and Grady Memorial Hospital. Dr. Bernal-Mizrachi is director of the Georgia Cancer Center for Excellence at Grady and leads the lymphoma and myeloma clinic there. He started practicing with Emory Healthcare

Page 10: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

in 2011. He is a member of the Cancer Cell Biology Research Program at Winship Cancer Institute and an expert in B-cell malignancies. The Bernal-Mizrachi translational research laboratory specializes in studying cancers of the immune system such as lymphomas and myelomas. Based on the premise that the cancer of each patient has unique characteristics, Dr. Bernal-Mizrachi's lab is focused on creating new technologies that allow matching each patient’s unique cancer growth signals with specific therapies that can block their cancer signal growth effect. At Grady Memorial Hospital, he provides specialized care in lymphoma and myeloma for patients who come predominantly from an indigent population. With over 700 lymphoma/myeloma visits per year, this busy clinic offers a variety of clinical presentations for each disease. In addition, this clinic enrolls patient in clinical trials and provides tumor samples to several research consortia.

Alfredo Voloschin, MDAlfredo Voloschin, MD, is Associate Professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine. A board-certified neurologist and neuro-oncologist, Dr. Voloschin's practice focuses in the management of primary brain tumors including gliomas and primary central nervous system lymphomas, as well as metastatic diseases to the nervous system and paraneoplastic neurologic syndromes. Dr. Voloschin has actively participated in neuro-oncology clinical trials at the Winship Cancer Institute of Emory University since 2008. He provides specialized care and training in the management of primary and secondary CNS lymphomas.

Emory Lymphoma Specialty TrainingIn addition to the faculty clinics described above, the Emory VICR program provides specialized clinical training in a number of clinical care conferences described below. These include a general lymphoma tumor board reviewing difficult management situations, tumor boards in the specialized care of CTCL and adolescent and young adult patients, and a focused lymphoid malignancies conference. There is also ongoing specialized focused care for inpatients with lymphoma and myeloma.

Lymphoma Tumor Board (1st and 3rd Monday of the month at 12:00 pm): newly diagnosed or relapsed patients are discussed amongst a multidisciplinary group of radiation oncologists, hematologists, and pathologists. We review pathology, discuss diagnosis and management, and provide consensus recommendations. Affiliate centers are also available for teleconference.

Cutaneous T-cell Lymphoma Tumor Board (2nd Monday of the month at 1:00 pm): newly diagnosed or relapsed patients with suspected CTCL are discussed amongst a multidisciplinary group of dermatologists, radiation oncologists, hematologists, and pathologists. We review pathology, discuss diagnosis and management, and provide consensus recommendations.

Lymphoid Malignancies Conference (2nd Friday of each month at 8:00 am) is a CME-certified teaching conference that builds on a developing clinical case teleconferencing system to promote collaborative learning among students and house staff. This multidisciplinary conference also provides the opportunity for interaction with leading experts in lymphoma clinical and translational research.

Adolescent and Young Adult (AYA) Lymphoma conference (4th Friday of each month at 1:00 pm) is a small, informal, research working group in which faculty and investigators from Emory Winship Cancer Center and Emory Children’s Hospital of Atlanta (CHOA) meet to discuss complex cases and research ideas addressing the needs of young patients (ages 15-39) with NHL and HL.

Page 11: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

Lymphoma/Multiple Myeloma (OMA) inpatient service is comprised of patients with lymphoma or multiple myeloma. Patients may be electively admitted for chemotherapy or autologous stem cell transplant, or they may be admitted for management of complications of their disease or its treatment. Walking rounds typically last from 10:00 am until noon and involve the attending physician, advanced practice providers, nurses, pharmacists, trainees, and Scholars.

VICR Training in Clinical Research Methodology and Curriculum. The focus of the VICR Program will be to enhance Scholars’ ability to successfully design and conduct clinical research studies and establish publications and grants to support productive careers in lymphoma clinical research. The initial workshop curriculum will support this focus through:

Intensive formal didactic sessions Small group sessions with expert faculty Establishment of long-term mentoring relationships with appropriate experts Development of peer-to-peer relationships Ongoing weekly experiences in clinical research training

Small group activities and didactic coursework will focus on clinical research design and implementation, as well as tips and strategies for analysis, grant writing, and publication.

Scholars will be expected to present their initial clinical study design at the start of the workshop meeting. Feedback on presentation skills from the Emory program Co-Directors will be provided to Scholars to enhance their presentation skills, and Scholars will present the revised study at the end of the workshop. In addition, they will develop and submit a Specific Aims page for a future career development grant.

After completion of the workshop, Scholars will be supported throughout the program by VICR faculty. Scholars will select a longitudinal mentor who will provide short-term advice on continued project development during the VICR Program and long-term career development guidance specific to the trainee’s objectives.

Over the course of the VICR experience, Scholars will attend two meetings following the initial workshop. During these meetings they will reconvene with one of the VICR Program Co-Directors to review progress on their research projects and discuss any existing pitfalls in the research, means to overcome them, and career development plans. Scholars will seek and receive guidance from the Co-Directors to overcome common obstacles in early academic career development.

Through these meetings and associated activities at each program, Scholars also will interact with international leaders in academic research. Scholars will have the opportunity to provide didactic lectures on aspects of lymphoma management and clinical research.

Research Training Workshop and Curriculum. Each cohort will begin with the Research Training Workshop, an intensive 4-day program during which Scholars will engage in a variety of learning experiences using different approaches accompanied by an equal or greater number of faculty members. Each Research Training Workshop follows a similar schema, although the specific sessions, faculty, and time allotment will be modified each year. The following are designated components of a Workshop: (1) Presentation of new clinical research proposals by Scholars; (2) Didactic sessions; (3) Interactive workshops; (4) Introduction of the flipped-classroom approach; (5) Small group sessions; (6) “Sessions on Demand”; and (7) Evening discussions to foster career and personal development. These are described in detail below.

Page 12: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

1. Presentations of Clinical Research Proposals by Scholars.Learning is most effective when applied to real-world settings and focused on a research project. Thus, applicants must propose a research project in their application.

Each Scholar presents his or her proposal in 15 minutes at the beginning of the Research Training Workshop

Scholars share in a dynamic way that expresses their self-awareness of weaknesses in their proposal and their openness to external critiques.

Initial presentation is video-recorded and feedback on the content and style of the presentations is provided by the Co-Directors.

Content, format, and delivery style of the presentations are refined during the small group sessions.

Each Scholar presents a revised research plan in 15 minutes at the end of the Research Training Workshop

2. Didactic Sessions to Present Key Topics. Didactic presentations from faculty are a key delivery mechanism for meeting many of the educational objectives of the Research Training Workshop with a specific focus on the critical competencies of methodological principles and responsible conduct of research. Topics addressed in the didactic sessions may change depending on evaluations, but the core group of sessions is relatively consistent throughout the years. Anticipated sessions are as follows:

The Answer is the Question will review the characteristics of a well-designed research question. It will set the groundwork for much of the work to be done during the workshop.

Introduction to Biostatistics will provide a review of several basic concepts: hypothesis tests, p-values, power, sample size, and regression analysis.

Systematic Reviews and Meta-Analysis will provide Scholars with an understanding of the difference between these two analytic approaches, as well as an introduction to the principles, interpretation, and critical appraisal of systematic reviews.

Comparative Effectiveness Research will provide a brief summary of the evolution of comparative effectiveness research, common methodologies, and its significance and impact on the current research landscape.

Patient-Reported Outcome Assessment in Clinical Trials will focus on patient-reported outcomes and health-related quality of life and will provide an overview of the rationale for using these measures in clinical trials.

How to Obtain a Career Development Award will include perspectives and advice from mentors on how to be successful in obtaining a career development award. The session will highlight funding opportunities from the NIH and foundations.

How to Craft an Effective Research Presentation will address characteristics of an effective research presentation and will apply to both oral and poster presentations. Examples of good and not-so-good slides and posters will be discussed.

Getting the last word– Publishing Results will provide an approach to writing a manuscript for a scientific journal. Importantly, this talk will focus on responsible conduct of research and will address issues including authorship, plagiarism, fabrication and misrepresentation.

Obtaining the Drugs includes steps on how to submit clinical trial proposals, an overview of the requirements of an investigational new drug (IND) trial, and means to optimize chances of success with these applications.

Early Career Tips will highlight areas of early career development such as negotiating a new position, building an academic portfolio, creating an academic niche, and establishing a path to promotion.

Importance of Good Mentoring will explain the role of the mentor and will provide examples of excellent and poor mentorship.

Conducting Clinical Research within Cooperative Groups will describe some of the major

Page 13: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

cooperative groups and will provide insight on how to maximize research opportunities. Presentations will be given from Children’s Oncology Group, Alliance for Clinical Trials in Oncology, and Blood and Marrow Transplant Clinical Trials Network.

The ABCs of Running Clinical Trials as a Team will focus on describing practical guidelines for forming and sustaining a multidisciplinary clinical research team. Issues related to responsible conduct of research such as the ethics of working with human subjects, obtaining research consent, data management, and privacy will be emphasized in addition to appropriate reasons for removing subjects from protocol therapy and reporting of adverse events.

Essential Skills for Emerging Leaders will provide an overview of the elements required to be an excellent leader and how to obtain those skills as a junior faculty.

3. Instruction in the Responsible Conduct of Research.Since comprehensive understanding of the responsible conduct of research is essential for research training and career development, didactic sessions within the VICR curriculum will focus on the responsible conduct of research. This coursework complies with NIH RCR requirements and was designed with the advice of expert faculty, national guidelines for ethics training, the Emory Ethics Center, and Postdoctoral Fellow recommendations to assure its relevance to these trainees now and in their future careers. These courses will be expanded upon under the guidance of the program Co-Directors annually based on Trainee’s needs. Additionally, most content sessions and mentoring sessions will include discussions of ethics and responsible research. The vast experience of the faculty will be reflected in the curriculum and these discussions during didactic lectures, small group sessions, and breakout session. Together these session will be designed and selected to ensure that Scholars and faculty engage in face-to-face discussions regarding: appropriate handling of human subjects and patient samples in clinical research; structuring highly effective mentor/mentee relationships; performing collaborative research including collaborations with industry; personal, professional, and financial conflict of interest; data acquisition, management, sharing and intellectual property; identifying, reporting, and addressing research misconduct; engaging in the peer review as an author and reviewer; advancing science in the broader community. Specific breakout sessions are also included to address: work-life balance, physician burnout, and balance in dual-professional households.

4. Interactive Workshops to Enhance Learning. In the last six months of year 1, there will be a shift from the didactic sessions provided in the foundational program to more interactive approaches with the objective of enhancing learning and retention. These sessions will include methodological principles and responsible conduct of research.

Overview of Trial Design will focus on observational and interventional trial methodology. Responsible conduct of research will be addressed by describing appropriate scenarios for placebo-controlled trials and early-phase studies.

Searching the Literature will address the steps in running a successful search to find evidence-based literature to support Scholars’ research and clinical needs. The session will include search terms, bibliographic management systems, and methods for effective and time-efficient searching of the primary and secondary literature.

Funding Organization Questions and Answers will address advice and tips on the right and wrong ways to approach grant applications and the components of good grant writing.

How to Avoid Conflicts of Interest and Maintain Ethics will focus on the responsible conduct of research and the various ethical dilemmas faced by patient-oriented investigators. This workshop will identify the most common sources of conflict of interest, discuss how to recognize them, and provide some strategies for how to deal with them. In particular, investigator misconduct and dealing with industry will be discussed. The format of the session will propose a series of dilemmas with each course Director taking opposing views.

Page 14: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

The Scholars will be asked to provide their perspective. Faculty members will also share their experiences and recommendations.

5. Emory Biostatistical and Informatics Support.We recognize the critical role effective training and support in biostatistics and informatics play in the career development of clinical investigators. The Biostatistics and Bioinformatics Shared Resource at Winship Cancer Institute of Emory University provides service and collaboration in clinical, laboratory, population, and molecular cancer study design and analysis. Quantitative areas of expertise include genomic analysis and genomic clinical associations, genome-wide cluster analysis, variable selection in functional response model, and biomarker-based trial designs. In particular, the VICR program will be supported by BBISR biostatistician, Dr. Jeffrey Switchenko.

Jeffrey Switchenko, PhD, MS, is a faculty member in the Department of Biostatistics and Bioinformatics at Rollin School of Public Health, and joined the Biostatistics and Bioinformatics Shared Resource at Winship Cancer Institute in February 2012. He is a member of the Cancer Prevention and Control research program at Winship, and has extensive experience in biostatistical methodology. His research background consists of spatial analysis within a Bayesian framework as a means of identifying populations at risk of obtaining diseases. He has collaborated extensively on clinical and genomic study design and analysis with the Emory Lymphoma faculty. He has worked with Dr. Flowers and colleagues to describe the spatial epidemiology of lymphomas in Georgia and seeks to apply Bayesian methodology to a wide variety of cancer research projects ranging from cancer prevention and control to genomic studies.

The Winship Research Informatics Shared Resource provide a variety of computational and data science resources to investigators and Emory and beyond. The WRI is led by Director Madhusmita Behera, PhD, and Scientific Director, Dr. Flowers. WRI core services include database design, development and management; data abstraction/collection; matching existing clinical and biological information resources to research needs; designing case report forms; clinical annotation for disease specific biospecimen banks; support for systematic reviews and meta-analysis (search strategies, data extraction, literature review, analysis); cohort discovery from large clinical data warehouse resources; access to National Cancer Database files for solid and hematologic malignancies; support for grants/manuscripts/meeting abstracts; and support for training programs. For many projects, the WRI works closely in collaboration with the BBISR.

6. Year-Long Mentoring Program In recognition of the key role mentors play in an emerging researcher’s development, the foundational VICR program required VICR applicants to have a well-defined VICR Research Mentor and, ideally, a home institution mentor who demonstrates clear support for the trainee through development of the VICR project and application, as well as a clear commitment to support the trainee throughout the VICR year-long experience. To supplement the guidance of the VICR Research and Home Mentors, the foundational program formalized a one-year mentorship program in which each trainee is matched with a VICR Career Mentor currently serving as VICR Faculty. VICR Co-Directors are responsible for ensuring that each trainee identifies a VICR Research Mentor prior to the Clinical Research Workshop and a VICR Career Mentor by the end of the Clinical Research Workshop. The following are proscribed for the VICR Mentee and VICR Mentors:

VICR Mentor spends one-on-one time with the VICR Scholar during the intensive Workshop and the year-long experience to review the research protocol and career development plan.

VICR Mentor provides feedback to the trainee’s Home Mentor. The Home Mentor and VICR Mentor have an opportunity to meet at the annual ASH meeting to solidify the VICR Scholar’s research plan and career development plan.

Page 15: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

VICR Scholar and VICR Mentor communicate at least monthly for the one-year period to discuss progress with the project, review career objectives, and identify barriers to career advancement. They should also continue communication quarterly during the year following the VICR experience.

It is expected that the VICR Scholar and the VICR Mentor will meet face-to-face at the ASH annual meeting following the VICR experience.

In order to facilitate the interactions between the Scholar, Home Mentor, VICR Research Mentor, and VICR Career Mentor, clear instructional materials will be refined and disseminated to introduce the concept and objectives of the VICR Mentor and Home Mentor to both mentors. Specific roles are described below (where X indicates the mentor’s responsibility). The VICR Research Mentor and Career Mentor may be the same individual or may be different members of the VICR faculty depending on the needs of the Scholar.

Delineation of Roles between Home Mentor, VICR Research Mentor, and VICR Career Mentor in Support of VICR Scholar

Home MentorVICR Research

Mentor

VICR Career Mentor

Develop research project X XImplement post-intensive workshop project

X Provide external guidance and help to overcome barriers with trial sponsor or cooperative group

Liaise with VICR community XProvide external letters of support (K award, Academic Appointment)

X

Secure space and institutional resources for project implementation

X

Provide connections with career opportunities

X X

Aid overcoming early career barriers

X X

In addition to the didactic lectures in the intensive clinical research training program, VICR Scholars will engage in a number of ongoing clinical research training experiences. These include the Lymphoma Research in Progress meeting, the Lymphoma Clinical Trials Working Group, and the Lymphoma Molecular Immunology Working Group as described below.

Lymphoma Research in Progress Meeting (Every other Monday at 10:00 am) provides an opportunity to discuss ongoing non-therapeutic studies within the lymphoma group. This meeting provides an informal opportunity to discuss new concepts, review data for upcoming abstracts and manuscripts in order to get input from the team, practice oral presentations and other lectures, and to review translational research opportunities within the group. Based on input from this meeting, lymphoma faculty and research staff members have led implementation of research projects presented at national meetings and published in high-impact journals. 

Lymphoma Clinical Trials Working Group (Wednesdays at 12:00 pm) encompasses all aspects of therapeutic clinical trials. This meeting is attended by all lymphoma faculty members, clinical staff, and research coordinators.  New clinical trials in development are discussed, and ongoing

Page 16: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

trials are reviewed, including potential patients, toxicities/adverse events, response assessments, and regulatory updates.  At this meeting, investigators have the opportunity to collaborate with each other and the specialized research staff to foster successful implementation of clinical trials.

Lymphoma Molecular Immunology Working Group (Every 3 weeks on Thursdays at 1:00 pm) is a small, informal, research working group in which participants formulate and present new ideas and research plans for studies involving evaluation of the immune system in the context of lymphoid malignancies. Each session includes a short research presentation of ideas (a 15-20-minute slide presentation) with time for feedback from others. Topics include updates on research progress, areas of new technologies or new interest to explore, or a new publications in this topic area for discussion.

Evaluating the immediate benefits of participation in the program A previously validated measure of self-efficacy, the Self-Efficacy in Research Measure (SERM), will be administered on day 1 prior to the beginning of the workshop and included in the survey following completion of the workshop. Pre- and post-program responses will assess change in self-efficacy. The SERM is a 33-item survey instrument that measures belief in one’s ability to conduct several aspects of research on a scale ranging from 0 (No Confidence) to 9 (Total Confidence). The SERM takes approximately five minutes to complete and has a Flesch-Kincaid readability index of grade level 11.2. Measures of research self-efficacy have been completed by academic Scholars from a wide variety of disciplines and have high internal consistency and data supporting their construct validity. This instrument assesses confidence in ability to perform specific research activities that can be delineated by four subscales: research design skills, practical application skills, quantitative and computer skills, and writing skills. A measure of research self-efficacy is sufficiently sensitive to detect change in research self-efficacy from the beginning to the end of a student’s participation in a single-semester research course. Sample Question: “How confident are you in your overall ability to complete a significant project?”

As noted above, the construct of self-efficacy, is a fundamental tenet of social cognitive theory, and it has been repeatedly demonstrated that that a high sense of self-efficacy is essential for application of knowledge into practice. A previous study revealed a positive relationship between research self-efficacy and the research training environment, and between self-efficacy and productivity. We expect that the VICR will provide training in clinical research methodology and mentorship that will allow application of these skills in clinical practice and academic research. We will evaluate the change in self-efficacy comparing the SERM components for research design skills and practical application skills prior to the start of the initial workshop and at the end of the workshop. We expect that Scholars will have an increase in these domains over the course of the program.

To evaluate the impact of other factors on these outcomes, at baseline prior to the start of the initial workshop we will also have Scholars complete the Research Training Environment Scale (RTES), a 45-item questionnaire with 9 subscales: (1) faculty modeling of research, (2) positive reinforcement of research career, (3) early opportunities for involvement in research, (4) teaching relevant biostatistics, (5) looking internally for research ideas, (6) science as a social experience, (7) teaching on research flaws, (8) focus on variations in investigator styles, and (9) connections between science and practice. RTES items are scored on a 5-point Likert-type scale with higher scores indicating respondents' stronger agreement that this component is present in the training environment. The RTES has been reported to have test-retest and internal consistency. Scholars and workshop faculty will complete evaluation surveys regarding the workshop didactic lectures and faculty at the end of the 3-day workshop. In exploratory analyses, we will examine

Page 17: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

relationships between baseline demographics, Scholars’ assessments of their research environment, and research self-efficacy. We will utilize these exploratory analyses to modify program objectives and curriculum to address the needs of Scholars for future research goals and career development needs.

Page 18: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

Example Emory Lymphoma Rotation ScheduleSunday Monday Tuesday Wednesday Thursday Friday Saturday

Week 1

AM

8:00 - ORIENTATION9:00 - Blum Clinic (ESJH)10:00 - Lymphoma RiPM meeting

8:00 - Cohen Clinic (2nd Floor)

7:30 - Grand Round (C5012)

8:30 - Flowers Clinic (Plaza)

8:00 - Blum Clinic (2nd Floor)11:30 - Hematology MultiDisc. Conference (C3018)

8:30 - Allen Clinic (Plaza)

PM

12:00 - Lymphoma Tumor Board (C3018)1:00 - Lechowicz Clinic (Plaza)

1:00 - Cohen Clinic (2nd Floor)

12:00 - Lymphoma WG Meeting (HSRB E260)1:00 - Flowers Clinic (Plaza)1:00 - Voloschin Clinic (Bldg B)

1:00 - Lechowicz Clinic (Plaza)

1:00 - Koff Clinic (Plaza)

Week 2

AM

10:00 - OMA Service Rounds (EUH)

8:00 - BMT Patient Conf10:00 - OMA Service Rounds (EUH)

10:00 - OMA Service Rounds (EUH)

7:30 - Grand Round (C5012)10:00 - OMA Service Rounds (EUH)

10:00 - OMA Service Rounds (EUH)11:30 - Hematology MultiDisc. Conference (C3018)

8:00 - Lymphoid Malignancy Conference (C3018)10:00 - OMA Service Rounds (EUH)

10:00 - OMA Service Rounds (EUH)

PM

4:00 - OMA Service Rounds (EUH)

1:00 - Lechowicz Clinic (Plaza)4:00 - OMA Service Rounds (EUH)

1:00 - Cohen Clinic (2nd Floor)4:00 - OMA Service Rounds (EUH)

12:00 - Lymphoma WG Meeting (HSRB E260)1:00 - Flowers Clinic (Plaza)4:00 - OMA Service Rounds (EUH)

4:00 - OMA Service Rounds (EUH)

1:00 – Koff Clinic (Plaza)4:00 - OMA Service Rounds (EUH)

4:00 - OMA Service Rounds (EUH)

Week 3

10:00 - OMA Service Rounds (EUH)

8:00 - BMT Patient Conf10:00 - OMA Service Rounds

8:00 - Cohen Clinic (2nd Floor)10:00 - OMA Service Rounds (EUH)

7:30 - Grand Round (C5012)8:30 - Flowers Clinic (Plaza)10:00 - OMA Service

8:00 - Lechowicz Clinic (Plaza)10:00 - OMA Service Rounds (EUH)

11:30 - Hematology

8:30 - Allen Clinic (Plaza)10:00 - OMA Service Rounds (EUH)

10:00 - OMA Service Rounds (EUH)

Page 19: €¦  · Web viewThe Winship Phase 1 unit supports all Emory clinical investigators including future OCPP post-doc ... lymphocytic leukemia and the ... word– Publishing

VISITING INTERNATIONAL CLINICAL RESEARCHER (VICR)

AM

Rounds (EUH) MultiDisc. Conference (C3018)

PM

4:00 - OMA Service Rounds (EUH)

12:00 - Lymphoma Tumor Board (C3018)1:00 - Lechowicz Clinic (Plaza)4:00 - OMA Service Rounds (EUH)

1:00 - Cohen Clinic (2nd Floor)4:00 - OMA Service Rounds (EUH)

12:00 - Lymphoma WG Meeting (HSRB E260)4:00 - OMA Service Rounds (EUH)

1:00 - Mol Imm WG (HSRB W200)4:00 - OMA Service Rounds (EUH)

1:00 - Allen Clinic (Plaza)4:00 - OMA Service Rounds (EUH)

4:00 - OMA Service Rounds (EUH)

Week 4

AM

8:00 - BMT Patient Conf8:00 – Blum Clinic (ESJH)12:00 - Lymphoma Tumor Board

8:00 - Cohen Clinic (2nd Floor)OR8:30 - Bernal Clinic (Grady)

7:30 - Grand Round (C5012)8:30 - Flowers Clinic (Plaza)

8:00 - Lechowicz Clinic (Plaza)

OR8:00 - Blum Clinic (2nd Floor)11:30 - Hematology MultiDisc. Conference (C3018)

8:30 - Allen Clinic (Plaza)

PM

1:00 - Lechowicz Clinic (Plaza)

1:00 - Cohen Clinic (2nd Floor)OR1:00 – Bernal Clinic (Grady)

12:00 - Lymphoma WG Meeting (HSRB E260)1:00 - Flowers Clinic (Plaza)OR1:00 - Voloschin Clinic (Bldg B)

1:00 - Lechowicz Clinic (Plaza)OR1:00 - Cohen clinic (ESJH)

1:00 - AYA Lymphoma Conf (CHOA) 1:00 - Koff Clinic (Plaza)OR1:00 - Allen Clinic (Plaza)

Week 5

AM

8:00 - BMT Patient Conf 8:00 - Blum Clinic (ESJH)

8:00 - Cohen Clinic (2nd Floor)OR8:30 - Bernal Clinic (Grady)

7:30 - Grand Round (C5012)8:30 - Flowers Clinic (Plaza)

8:00 - Blum Clinic (2nd Floor)OR8:00 - Lechowicz Clinic (Plaza)

8:30 - Allen Clinic (Plaza)

PM 1:00 - Lechowicz Clinic (Plaza)

1:00 - Cohen Clinic (2nd Floor)1:00 – Bernal Clinic (Grady)

12:00 - Lymphoma WG Meeting (HSRB E260)1:00 - Flowers Clinic (Plaza)OR1:00 - Voloschin Clinic (Bldg B)

1:00 - Lechowicz Clinic (Plaza)OR1:00 - Cohen clinic (ESJH)

1:00 - Koff Clinic (Plaza)OR1:00 - Allen Clinic (Plaza)