We at CCS are proud to announce our the publication of our systematic review of applied transportability and generalizability analyses. This review is a landscape analysis intended to give an overview of all of the published applications of transportability and generalizability analyses using real data.

We’re excited to share that the Target Aggregate Data Adjustment (TADA) Method is now implemented in our {TransportHealth} R package!

The deadline has passed to submit feedback on Canada's Drug Agency’s draft Methods Guide for Health Technology Assessment, which outlines a framework for appraising clinical evidence in health technology assessments (link). At CCS, we contributed comments emphasizing the need for methodological rigor and innovation to ensure assessments are both scientifically sound and practically relevant.

Yesterday was the last day to submit comments on the Food and Drug Administration’s (FDA) most recent draft industry guidance on diversity in clinical trials, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (link). Here at CCS, we took this as an opportunity to highlight the need for process metrics for diversity in 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In December 2022, Health Canada released draft guidance on requirements for disaggregated data in new drug submissions.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.

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.

In this newsletter, we provide an overview of the history of diversity at the FDA, highlight the key messages from the draft guidance, and review how the CCS team can help overcome some of the challenges implementing this latest guidance.