A Framework for Safety Evaluation Throughout the Product Development Life-Cycle.

Evaluation of the safety profile of medicines is moving from a more reactive approach, where safety experts and statisticians have been primarily focusing on the review of clinical trial data and spontaneous reports, to a more proactive endeavor with cross-functional teams strategically evolving their understanding of the safety profile. They do this by anticipating the ultimate benefit-risk profile and its related risk management implications from the start of development. The proposed approach is based on assessments of integrated program-level safety data. These data stem from multiple sources such as preclinical information; clinical and spontaneous adverse event reports; epidemiological, real-world, and registry data; as well as, potentially, data from social media. Blended qualitative and quantitative evaluations allow integration of data from diverse sources. Adding to this, a collaborative multidisciplinary view, which is focused on continuous learning and decision-making via diverse safety management teams, ensures that companies look at their growing safety database and associated risk management implications from every relevant perspective. This multifaceted and iterative approach starts early in the development of a new medicine, continues into the post-marketing setting, and wanes as the product matures and the safety profile becomes more well understood. Not only does this satisfy regulatory requirements but, crucially, it provides the healthcare system and treated patients with a better understanding of the drug's safety profile.

Duke Scholars

Author Frank Wesley Rockhold Biostatistics & Bioinformatics, Division of Biostatistics