Risk-Based Monitoring For Late-Phase Research: Strategies For Real-World, Post-Approval Studies

By Maria Harrison, Vice President, Late Phase Services, PRA Health Sciences

As seen in recent regulatory guidance (i.e., the FDA’s final guidance, the EMA reflection paper and the MHRA Risk Adapted Approaches, support for the utilization of multiple monitoring approaches in clinical research has grown. In addition, industry initiatives such as the Clinical Trials Transformation Initiative (CTTI) and the recent TransCelerate position paper4 have provided preliminary guidance on how to incorporate RBM.

Despite the increased enthusiasm, many organizations still employ 100% SDV for most of their projects. The recent Industry Standard Research (ISR) survey that examined the attitudes of pharmaceutical and biotechnology professionals found that 73% of the respondents believed that RBM is risky from an operational standpoint, suggesting that although many research professionals are interested in RBM, they are cautious about implementing the approach into their studies.