jss medical research paces pmos heor

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9400 Henri-Bourassa Boulevard West Montreal, Quebec, Canada, H4S 1N8 Tel: 514-9346116 Fax: 514-9349913 www.jssresearch.com A science-based contract research organization where scientific expertise meets operational excellence Post Approval Clinical and Epidemiological Studies (PACES) Post Market Observational Studies (PMOS) Health Economics and Outcomes Research (HEOR) 25/06/2015 1

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9400 Henri-Bourassa Boulevard WestMontreal, Quebec, Canada, H4S 1N8Tel: 514-9346116 Fax: 514-9349913

www.jssresearch.com

A science-based contract research

organization where scientific expertise meets operational

excellence

Post Approval Clinical and Epidemiological Studies (PACES)

Post Market Observational Studies (PMOS)

Health Economics and Outcomes Research (HEOR)

25/06/2015   1  

JSS Medical Research

Headquartered in Montreal

>25 years in business

Privately held and financially stable

Experienced management team

An international full-service CRO with study involvement in over 20 countries

Largest Canadian-owned CRO

Approximately 200 ongoing projects in fiscal 2016

Growing client list includes global big pharma (14 of top 25) biotechnology and device companies

80% repeat business

290 full time + 49 regionally based contract staff

Aug  2015   2  

We offer solutions and insights for all developmental phases and post-approval needs for a wide range of therapeutic areas worldwide.

A full service CRO with PACES experience and expertise

3  

JSS Medical Research was founded by Dr. John S. Sampalis, a Clinical Epidemiologist trained at McGill University and the Division of Clinical Epidemiology of the Montreal General Hospital. Dr. Sampalis is currently a professor of Surgery and Epidemiology and Biostatistics at McGill University, University of Montreal and University of Laval.

The epidemiologists, biostatisticians and project managers at JSS Medical Research possess the exact training and experience that is required to conceive, design, and execute the study, analyze the data and disseminate results for regional Canadian PACES. Clinical operations, project management and quality assurance at JSS Medical Research are guided by the clinical research and epidemiology nucleus.  Consequently, JSS Medical Research is the ideal full service Clinical Research Organization (CRO) partner for conducting post-approval studies in a wide range of therapeutic areas. The publication record of over 200 publications in peer reviewed journals and over 300 presentations at scientific conferences is testimony to our scientific excellence.

Aug  2015  

Post Approval Clinical & Epidemiological Studies (PACES)

Aug  2015   4  

that of the Phase II and III Registrational studies.

While Phase II – III controlled clinical trials provide evidence of efficacy under ideal conditions, PACES are the only source of information that allows for the assessment of real-life effectiveness. In addition, ongoing surveillance for safety signals under routine clinical practice that allows for the detection of rare but potentially serious adverse events can only be accomplished by the accumulation of data from several PACES that capture data from large populations and over sufficient periods of treatment exposure.

Post-Approval Clinical and Epidemiological Studies (PACES) that include Phase IV and Post-Marketing Observational Studies (PMOS) have evolved into an integral and essential phase of the drug development life cycle with implications that have comparable weight to

must take into consideration regional needs and treatment gaps that are less relevant in global studies. It follows that, at the minimum, country specific PACES will be required to conduct regional evaluations of marketed treatments. However, the aggregation of evidence from several regions or countries could be employed to provide global assessments.

Given the importance of PACES and the potential implications of the results to health care stakeholders, it is essential that these studies be conducted with the same scientific rigor as Phase II and Phase III studies.

Post Approval Clinical & Epidemiological Studies (PACES) continued

Aug  2015   5  

One of the most important considerations of PACES is regional specificity. This is due to regional variations in the patient profile, cultural influences, practice patterns and local reimbursement policies affecting access to care. Consequently, the design and conduct of PACES

Post Approval Clinical & Epidemiological Studies (PACES) continued

Aug  2015   6  

incorporate advanced methods to compensate for the lack of randomization, non-standardized follow up and the observational nature of the design. As such, PACES must be conducted under the aegis of clinical or health outcomes departments of pharmaceutical sponsors in collaboration with third parties that have experience in the design, conduct and analyses of epidemiological studies with appropriate training in the field.

Clinical epidemiology provides the only methodological platform upon which PACES can be developed and executed. Essential elements of properly conducted PACES include well defined hypotheses addressing knowledge gaps that define clear objectives and research questions. Statistical considerations must include precise sample size requirements that ensure sufficient power to address the research objectives, as well as statistical analyses that

Post Approval Clinical & Epidemiological Studies (PACES) continued

Aug  2015   7  

which should be considered as the real-life extension of the Phase III Registrational studies. Under the Phase IV studies, treatment effectiveness for specific patient subgroups or enriched populations can be evaluated. Randomization for the assessment of differences with respect to treatment effectiveness is also possible in Phase IV studies.

While Phase IV studies emulate a real-life setting, the fact that the sponsor provides medication to the patient at no cost affects the generalizability with respect to access of care and compliance that is artificially enhanced in the Phase IV setting. Furthermore, Phase IV studies are conducted under pre-determined protocols dictating patient follow up schedules and assessments. Nevertheless, there is significant value in Phase IV studies,

Post Market Observational Studies (PMOS)

Aug  2015   8  

by the patients themselves. PMOS provide evidence on real-life effectiveness and safety in combination with assessment of health care utilization, direct and indirect health care costs that are essential for a comprehensive health economic evaluation, and assessment of treatment impact on burden of illness.

Post-Marketing Observational Studies (PMOS) are true epidemiological studies in which treatment is provided to patients without any intervention by the sponsor or the investigator. In the PMOS, payment for treatment is provided as per real life, including insurance plans or

Importance & benefits of Phase IV & PMOS studies

Aug  2015   9  

•  Assess real-life efficacy (effectiveness) and safety

•  Assess compliance and adherence

•  Assess patient & physician satisfaction

•  Assess patient outcomes such as quality of life, productivity, satisfaction, health care utilization

•  Determine treatment and safety gaps

•  Assess subpopulation

•  Generate hypothesis

•  Increase familiarity with treatment

Phase IV studies & Observational studies are important and beneficial to:

Aug  2015   10  

Marie Maxime Hubert, B.Sc., M.Sc.Manager, Health Economics and Outcomes Research

Ms. Hubert holds a bachelor in biomedical sciences, a graduate diploma in drug development and a master’s degree in pharmaceutical sciences with a double specialization in pharmacoepidemiology and pharmacoeconomics. She gained a practical understanding of economics, data analysis and drug policies as economic consultant atIMS Health. She has experience in market access from roles in multinational pharmaceutical companies; preparing the launch of a new chemical entity (dronedarone, Sanofi-Aventis) as well as generating pharmacoeconomic evidence for established indications (adalimumab, AbbVie – formerly Abbott).

Ms. Hubert also led multidisciplinary teams in the design and execution of treatment adherence studies. Ms. Hubert has built reimbursement dossiers for individual provinces, private drug plans, Quebec’s Institut national d’excellence en santé et en services sociaux, the common drug review (CDR) and the pan Canadian Oncology Drug Review. She also reviewed reimbursement submissions as part of her duties as health economist for the CDR at the Canadian agency for drugs and technologies in health. After completing a contract with JSS Medical Research as independent consultant, Ms. Hubert joined the team as Manager, Health Economics and Outcomes Research (HEOR). She is currently expanding the HEOR franchise at JSS Medical Research.

Health Economics and Outcomes Research (HEOR)

Aug  2015   11  

Increasingly, payers and healthcare service providers around the world are becoming more knowledgeable about this and require HEOR to be conducted with rigorous scientific methods.

HEOR measures the indirect treatment comparison that can be described as a way of pooling clinical evidence to establish the relative efficacy of treatments never compared against each other but compared against a common comparator, without breaking randomization.

Health Economics and Outcomes Research (HEOR) demonstrates the cost-effectiveness of drugs by comparing to the gold standard treatment in current practice. This is expressed as a ratio of the incremental cost per incremental health benefit.

Health Economics and Outcomes Research (HEOR)

Aug  2015   12  

•  Scientific rationale•  Clinical summary•  Burden of illness•  Cost of illness•  Pharmacoeconomic assessment:

•  Cost-utility analysis•  Cost-effectiveness analysis•  Cost-minimization analysis

•  Net impact (adopting a societal perspective)

•  Budget impact analyses• 

Leveraging expertise in health economics, experience working in the multinational pharmaceutical companies, consultation firms and the Canadian reimbursement agency, JSS Medical Research HEOR management can lead the development of the reimbursement dossier or its adaptation for practice, including:

Health Economics and Outcomes Research (HEOR)

Aug  2015   13  

It should also take into consideration healthcare policies, patient associations and the reimbursement landscape.

As a science-based CRO operated by professionals with years of experience in the pharmaceutical industry, our value proposition is based on high quality analyses that can convincingly demonstrate the value of your product, performed under the sponsor’s timelines, with the support of key opinion leaders, without compromising the scientific rationale.

Given its core capabilities in biostatistics, data analysis, meta-analysis and modeling, JSS Medical Research can design and perform the appropriate analyses to allow you to gain or optimize reimbursement. In a holistic approach, the submission dossier should contain a value proposition supported by clinical, economic, and humanistic data.

At JSS Medical Research we offer solutions & insights for all developmental phases & post-approval needs

Aug  2015   14  

D r u g d e v e l o p m e n t

Clinical Phase I-III

Late and post-approval phase

Market Access & HEOR

Across the lifecycle

•  Phase I•  Phase II•  Phase III-IIIb•  Medical Devices

•  Phase IV•  PMOS•  Chart Review•  Registries•  Databases Analysis• Epidemiological Surveys

•  Health Technology Assessment•  Value Proposition•  Budget Impact Analysis

•  Strategic Assessments•  Study Design•  Risk Management•  Epidemiological Study•  Patient Reported Outcomes•  Literature Review•  Advanced Biostatistics•  Investigators Initiated Studies•  Rescue Analysis•  Survey•  Monitoring•  Other: Staffing, Courses, QA & GCP

JSS Medical Research Capabilities

9400 Henri-Bourassa Boulevard WestMontreal, Quebec, Canada, H4S 1N8Tel: 514-9346116 Fax: 514-9349913

www.jssresearch.com

A science-based contract research

organization where scientific expertise meets operational

excellence

For More Information ContactAnn VawterDirector, Business Development & Marketing Ph: +1.919.424.3332Email: [email protected]

25/06/2015   15  

Thank You