Developing Holistic Safety Risk Management

Life science companies have public responsibilities beyond those of ordinary business ethics. Public safety is paramount and, in the context of drug development, it is important to make all reasonable efforts to understand the emerging benefit and risk profile of a product. This will not only ensure that the patients entering trials are protected, but that the risk of product failure is appropriately managed. Recent drug withdrawals and failures to obtain approval have put both industry and regulators under pressure to improve safety surveillance during drug development. This has led to pressures to bring the safety risk management processes of pharmacovigilance (PV) into earlier phases of development, thus making it increasingly business-critical.

Traditionally, the approach to drug safety in clinical trials has been based on the end of study analysis of individual trial data, with adjustments being made to risk and benefit statements in the investigator’s brochure – which would then go on to be the safety benchmark for subsequent trials and form the basis of the final core safety information. However, this approach is no longer enough. In an environment where many companies have yet to establish robust systems for post-marketing signal detection and management there is a clear and increasing need to use PV approaches to look for safety signals during clinical trials. If you don’t, or don’t do it correctly, then someone else will. When Bristol-Myers Squibb and Merck had a positive Advisory Committee hearing for their dual PPAR agonist, Muraglitazar, they could not have realised that a meta-analysis of their trials by an independent group of medical academics would have highlighted safety concerns that led to its failure to reach the market.