building relationships with your investigators... · building relationships with your investigators...
TRANSCRIPT
![Page 1: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/1.jpg)
Building Relationships with your Investigators
James N. Atkins, MD
Southeast Clinical Oncology Research (SCOR) NCORP with Southeastern Medical Oncology Center
in Goldsboro, NC
CRP Education Meeting, Friday, May 15, 2015
![Page 2: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/2.jpg)
Objectives
l Learn how communication within the research team leads to better understanding of research protocols
l Learn how communication with cancer patients can increase trust
l Learn the importance of nurses/CRPs in the clinical trial process
![Page 3: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/3.jpg)
What does it mean to be a professional? Why does your physician want to do clinical trials?
![Page 4: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/4.jpg)
![Page 5: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/5.jpg)
Why do we do clinical
trials or research?
For our patients
and for all the patients
of the world.
![Page 6: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/6.jpg)
Commitment to Continuous Learning:
New Chemotherapy Drugs
Sir William Osler said “it is important to use a drug
early while it is still effective.”
![Page 7: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/7.jpg)
Your Investigator
l Will want to use drugs early to try to help his patients
l They may look at cancer as a “Chess game” with the doctor and patient playing against the cancer
l This can affect their judgment as they push the envelope to get them on study
![Page 8: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/8.jpg)
The ability to create knowledge l Every patient who does not get offered a clinical
trial slows the fight to cure cancer and ultimately increases the death rate from cancer
l The knowledge that we have today is inadequate → we must learn more
![Page 9: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/9.jpg)
Accruing to clinical trials can be difficult
l Accruing to clinical trials is a skill and there is a learning curve
l Building the relationships with investigators can be challenging
l Hopefully, you will learn things that may help you and your team accrue to clinical trials
![Page 10: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/10.jpg)
Why is it important to be a “Clinical Trialist”?
Applying theoretical knowledge to practice:
![Page 11: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/11.jpg)
5 Yr. Survival Myeloma
l 1970s 26% l 1996-2002 33% l Pts on clinical trials - approx 50%
![Page 12: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/12.jpg)
Research l Represents medicine’s new frontier and
greatest hope l Leads doctors to new and improved treatments l Helps save lives and reduces the cost of
medicine
![Page 13: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/13.jpg)
Clinical Trialist l Believes in the scientific process l Is curious about how we can improve the
treatment of an illness l Believes we do not have all the answers and the
treatment of illnesses will change with time
![Page 14: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/14.jpg)
Clinical Trialist l Willing to spend the time and energy needed to
advance medical knowledge l Not willing to accept the “status quo” as “the-
state-of-the-art” when it comes to treatment l Is altruistic
![Page 15: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/15.jpg)
Protocol Barriers l Presentation of the protocol:
l Body language of physician and staff l Tone of voice and eye contact l Enthusiasm l Conviction that the protocol is the “state-of-the-art”
treatment l Don’t talk “over” the patient and not listen to patient l “I would not put my family on that trial”
![Page 16: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/16.jpg)
Enthusiasm and Commitment to Customers:
l Some physicians indicate they don’t find the trial interesting. So they don’t put the trial through their IRB or open the study; therefore, their patients don’t have the option of participation in the trial.
l The patients should have the choice. The physician should not be so paternalistic.
l These are your low accruing doctors
![Page 17: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/17.jpg)
Patient Perspectives l Receive medical benefits from the clinical trials l Benefit from increased monitoring and care l Peace of mind l Motivated by a desire to help others or a desire
to help the investigators
![Page 18: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/18.jpg)
As oncologists, we owe society our best effort to cure cancer.
This means placing all eligible patients on clinical trials.
We can make errors in judgment as to who should go on study.
![Page 19: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/19.jpg)
Personal Satisfaction There is a lot of satisfaction in putting patients on
studies which, in turn, changes the way we treat our patients.
It is humbling when the studies we are using
change our biases.
![Page 20: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/20.jpg)
What are the Issues? l Discussing the protocol
l Audio taping the discussion → this is critical in my opinion.
l Developing the trust l Explaining it in a way the patient and family can
understand l Ethical issues l Not putting patients on study who are not eligible
![Page 21: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/21.jpg)
Capacity to Solve Problems: Discussing the Protocol
l Audio tape the discussion l Most pts. will not hear what you say l Give them a copy of the audio tape l “Information block” mode l Their mind is thinking about all sorts of things when
you say certain key words l One patient remembered only 2 items
![Page 22: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/22.jpg)
Commitment to Customers: Developing Trust
l Give them the time they deserve l Don’t look rushed even if you are l Act as if they are the only patient you have that
day l Remember, non-verbal language is real
![Page 23: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/23.jpg)
Professionals l Prevent fabrication of data l Generate quality data l Keep data current l Take pride in your work l Take pride in helping the patients on clinical
trials
![Page 24: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/24.jpg)
Professionals l Work as a “team” l Value the input of team members l Value the time and effort of the patients and
recognize their contribution and altruism
![Page 25: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/25.jpg)
Ineligible patients l How to deal with a physician who is trying to
enroll an ineligible patient l Go over the eligibility list with the doctor l Point out your area of concern l Send the executive officer an email with the specific
question l Document what the executive officer has said
![Page 26: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/26.jpg)
Ineligible patients If the executive officer says the patient is or is not eligible, that is the final answer. You cannot put a patient on a study if they are ineligible. It is a protocol violation. If it is intentional, it is fraud. Exceptions to eligibility cannot be granted
![Page 27: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/27.jpg)
Ineligible patients You are there to protect the patients from going on studies to which they are not eligible You have to work as a team which means you have to speak up When you work as a team magic happens and when you don’t . . . .
![Page 28: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/28.jpg)
Flying a 777
![Page 29: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/29.jpg)
Too low on approach
![Page 30: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/30.jpg)
Ineligible patients l What happened? l Why did the co-pilot not work with the pilot? l Why did they not see the problem ahead? l You have to break the chain of mistakes
![Page 31: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/31.jpg)
Errors l How do deal with a physician who is making
errors with protocol tests and data l Put the orders into the computer yourself before the
patient comes to the office (make it easier for the doctor)
l Have a policy stating after the pt. sees the doctor, the chart goes to the research staff for review
![Page 32: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/32.jpg)
Errors l Research staff reviews every patient before treatment
to make sure dose adjustments are made correctly due to toxicity
l If there is required documentation not being created, give the physician a note reminding them to make comments about specific toxicities.
![Page 33: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/33.jpg)
The Team l Alone we cannot change the treatment of
cancer. We must work together!!
![Page 34: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/34.jpg)
The Team l Nurses are critical in:
l Dealing with drug logs and dose modifications l Double checking with the physician when toxicities are
discovered and the patient forgets to mention to the physician.
![Page 35: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/35.jpg)
The Team l Nurses are critical in:
l Helping explain the treatment to patients l Helping to monitor side effects l You must have nurses understand the importance and
value of clinical trials in order for them to be on board
![Page 36: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/36.jpg)
The Team l CRP (Clinical Research Professional)
l Makes sure data is submitted in a timely fashion according to protocol guidelines
l Makes sure no fabrication of data occurs l Makes sure forms are filled out in timely fashion
![Page 37: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/37.jpg)
The Team l CRP
l Evaluates patients for eligibility l Makes sure tests are ordered on time l Makes sure toxicities are recorded l Makes sure physicians follow the protocol l Makes sure . . . .
![Page 38: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/38.jpg)
The Team l Lab Personnel l Front desk/receptionist l Research/Chemotherapy/Staff nurses l Pharmacy/research pharmacist
![Page 39: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/39.jpg)
The Team l The team is not only the physician l The team is a group of individuals working together l In accruing to clinical trials, the team is what works.
No one person is more important than another. Example: The brain is not more important than the heart,
lungs or blood. All have to work together for the body to function.
![Page 40: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/40.jpg)
Ethics l A fine balance exists between scientific
advances and the protection of patients. The first step in the evolution of ethics is a sense
of solidarity with other human beings. Albert Schweitzer
![Page 41: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/41.jpg)
Ethics l The public’s perception of research, its benefits,
and its risks are shaped by the way research is conducted.
l It is essential the research community comes to value the ethics of research as central to the scientific process.
![Page 42: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/42.jpg)
Ethics l The research community as a whole suffers
when even a few investigators ignore basic principles of ethics.
l Scientific misconduct and fraud should never occur.
![Page 43: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/43.jpg)
“… Any deterioration in the protective foundation we have laid can cause direct harm to human subjects of research and indirect harm to the reputation of the investigators, their academic institutions, and the entire research community...
![Page 44: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/44.jpg)
“…Moreover, if we are to keep testing new medicines and new approaches to curing disease, we cannot compromise the trust and willingness of patients to participate in clinical trials”. Donna Shalala, Ph.D. NEJM 9/14/2000
![Page 45: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/45.jpg)
Why do we conduct clinical trials?
![Page 46: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/46.jpg)
For our patients
and for all
the patients
of the world
![Page 47: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/47.jpg)
Professionals Imagine the impossible . . . . . .find a way to do it!
![Page 48: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/48.jpg)
![Page 49: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/49.jpg)
“There is nothing impossible to him who will try.” Alexander the Great
![Page 50: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/50.jpg)
![Page 51: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/51.jpg)
Team l We have to work together l You have to develop a team l You must communicate l You must protect your patients’ rights l You must ensure the right tests are done at the
right time and the right drugs are given to the right patient
![Page 52: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/52.jpg)
This is unacceptable
![Page 53: Building Relationships with your Investigators... · Building Relationships with your Investigators James N. Atkins, MD Southeast Clinical Oncology Research (SCOR) NCORP ... advance](https://reader033.vdocument.in/reader033/viewer/2022052723/5f0d72c17e708231d43a680e/html5/thumbnails/53.jpg)
Conclusion l Questions