Risk Management Planning And Mandated Post-Authorization Studies

By Agnes Rivaille, PRA

Proactive planning is a key to successful post-marketing risk management execution. By planning for post-marketing and risk management activities early in the drug development process, sponsors can facilitate a greater “return on investment” and avoid paying for unnecessary activities.

The numbers and types of patients taking a product post-approval vary greatly from those studied in earlier phase clinical trials (Figure 1). The length of exposure can be significantly greater as well. Post-marketing studies help to identify trends, outcomes and signals in large “real-life” populations.