Susan D. Ross MD, FRCPC

Course Description

This module will explain how the principles and practices of evidence-based medicine (EBM) are applied through Phase 1 - 4 of a product lifecycle. Brief case studies will be presented to illustrate how systematic reviews and meta-analyses are used by Pharma in drug development and commercialization, specifically in Clinical R&D, Safety/Risk Management, Commercialization and Life Cycle Management.

In addition, further ways in which systematic reviews and meta-analyses could be used to greater advantage in drug development and commercialization will be discussed. These ways include choosing hypotheses for clinical trials, working with data safety monitoring boards (DSMBs) and Investigational Review Boards (IRBs), developing competitive intelligence for Marketing, providing Regulatory support as inclusions in periodic safety updates (PSURs) and Integrated Summaries of Safety (ISS) of New Drug Applications, or enhancing due diligence evaluations for in-licensing new products.

Learning Objectives

By the end of the Systematic Review & Meta-Analysis: Applications module, you will be able to:

  • Understand how to perform and how to critically appraise systematic reviews and meta-analyses of drug trials.
  • Appreciate the pros and cons of using systematic reviews to inform healthcare policy and practice decisions re: the efficacy, effectiveness, and safety of drugs.
  • Learn how systematic reviews/meta-analyses are and will be used for drug development and commercialization activities by industry.
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