Health Canada: Applying the Sex- and Gender-Based Analysis Plus Framework to Clinical Trials
In December 2022, Health Canada released draft guidance on requirements for disaggregated data in new drug submissions. Read on as we review the latest guidance in the context of broader Federal moves to consider intersectionality in policy and highlight some of the challenges moving forward.
Mind the Gap: EMA Guidance on Diversity in Clinical Trials
Demonstrating its commitment to aligning global standards in clinical trials, the European Medicines Agency (EMA) has adopted three ICH guidelines that are particularly relevant to diversity in clinical trials as well as EU Clinical Trial Regulation No 536/2014. Although these are important steps forward, the EMA’s adopted guidelines and regulation has notable gaps.
How to Act on FDA Guidance on Diversity Plans for Clinical Trials
In this newsletter, we provide an overview of the history of diversity at the FDA, highlight the key messages from the draft guidance, and review how the CCS team can help overcome some of the challenges implementing this latest guidance.
A Primer on Global Regulatory Guidance for Diversity in Clinical Trials
The global regulatory landscape is undergoing important changes: individual regulatory bodies around the world are introducing initiatives to enhance diversity in clinical trials. Differing regulatory mandates are not new for clinical development programs, but effectively navigating diversity guidance will require a comprehensive understanding not just of the global regulatory landscape but also why these initiatives are needed and what they hope to achieve.
