Post-Marketing Observation Studies (PMOS) and Phase IV Studies

The intrinsic differences between clinical trials and real-life utilization of drugs create treatment and safety gaps that can undermine return on investment for all health care stakeholders. Safety issues and reduced efficacy observed in real life can limit the overall benefits and value of marketed drugs.

While Phase II – III controlled clinical trials provide evidence of efficacy and safety under ideal conditions, Post-Approvals Clinical & Epidemiology Studies (PACES) including Post-Marketing Observational Studies (PMOS) and Phase IV studies are the only sources of information that allows the assessment of real–life effectiveness and safety. In addition to long term assessment of effectiveness and safety, these studies are ideal for generating data regarding patient adherence/compliance to treatment and its impact on effectiveness. Practice patterns and adherence to treatment guidelines by physicians can only be assessed with PACES.

These studies have evolved into an integral and essential phase of the drug development life cycle with implications that have comparable weight to that of the Phase II and III registrational studies. Given the importance of the PACES and the potential implications of the results to health care stakeholders it is essential that these studies are conducted with the same scientific rigor as Phase II and Phase III studies.

The webinar will cover the following:

• What are the objectives of PMOS and Phase IV studies?
• What are the possible designs of PMOS and Phase IV studies?
• What are the considerations when conducting PMOS and Phase IV studies?
  • Objectives
  • Study Design
  • Statistics
  • Randomization
  • Non-standardized follow-up
  • Data analysis
• What are the advantages and disadvantages of PMOS and Phase IV compared to other post-approval studies design?
• What are the challenges in conducting theses type of studies?
• Some examples of PMOS and Phase IV.

Speaker

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.

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