Effectiveness and safety observed in real-life can differ significantly from efficacy and safety observed in clinical trials creating treatment and safety gaps. This can undermine return on investment for drug developers and efficient use of funds for both public and private healthcare providers and payers. All stakeholders are pressured to generate more evidence either to gain reimbursement, competitive advantages and insights into real-life effectiveness and safety, or to improve adherence/compliance and healthcare deliveries.
While Phase II – III controlled clinical trials provide evidence of efficacy under ideal conditions, Post-Approvals Clinical & Epidemiology Studies (PACES) including those using healthcare administrative databases analysis are sources of information that allow the assessment of real – life effectiveness. Pharmaceutical companies, insurers, payers and benefits managers are increasingly using these databases to conduct observational studies to generate evidence. Using real-life administrative databases could help close the treatment and safety gaps created by the intrinsic differences between clinical trials and real-life utilization of drugs.
While there is an increase demand for more evidence, there is also more data available to conduct such studies. These studies are effective in assessing real-life utilization of specific treatments with short study time at a significantly lower cost than prospective data collection studies.
The webinar will cover the following:
- What are the objectives of healthcare administrative data and registries analysis?
- What are the possible designs of these observational studies?
- What are the variables available in these databases?
- What are the pros and cons of administrative database analysis compared to other post-approval studies design?
- What are the challenges of conducting theses type of studies?
- Some examples of healthcare administrative databases analysis.
John S. Sampalis, B.Sc., B.A. (Hon.), M.Sc., Ph.D., F.A.C.E., Founder, CEO and Chief Scientific Officer, JSS Medical Research Inc.
Dr. Sampalis is a clinical epidemiologist with undergraduate training in Microbiology, Immunology and Neuroscience and graduate training in Clinical Epidemiology and Biostatistics (M.Sc. and Ph.D.) from McGill University. Currently a tenured Professor of Surgery and, Medicine with the Faculty of Medicine of McGill University, University of Montreal and University of Laval, Director of Surgical Research Jewish General Hospital, Head Surgical Epidemiology Division of Surgical Research McGill University. He has extensive expertise in health services research, clinical trials and the evaluation of medical technology.
Who Should Attend?
– VPs/Director of Medical Affairs
– Medical Advisors
– Medical Science Liasons
– VPs/Directors/Managers of Health Economics & Drug Reminbursements
– VPs/Directors/Managers of Marketing
For pharmaceutical and biotechnology companies
Founded in 1985, JSS Medical Research Inc. is a Contract Research Organization that manages Phase I to Phase IV trials and specializes in Outcomes Research on behalf of Pharmaceutical, biotech and nutraceutical companies. The organization responds to the evolving needs of the stakeholders in the healthcare field for high quality, scientifically rigorous and sound clinical research services.