Benefit Risk Management, RiskMAPs, REMS

The goal of RiskMAPs (risk minimization action plans) and benefit risk management is to enhance appropriate and effective use of drugs and devices and to prevent adverse events due to their use or misuse. Pre-approval studies often provide important clues as to potential risks of products after launch. However, some risks and benefits are not apparent within the timeframe in which most clinical trials are conducted, and some risks and benefits are so small as to be virtually undetectable in modestly sized studies.

Regulatory agencies, such as the FDA and EMA, are looking for sponsors to build post-approval risk management programs as part of the approval process. Risk minimization programs should be built to address key regulatory concerns, using a multi-modality approach, whether designed to impact education or behavior, detect a special event, or to monitor off label use. Quintiles Outcome has developed a number of risk minimization programs using a standardized and measurable approach to key elements, such as education, monitoring, and performance linked access. Each element is part of an integrated, measurable, and ultimately defensible strategy.