
Making Sense of Uncertainty with Simulation: New Paper in Value in Health
Despite their benefits, uptake of value-based contracts has been limited, perhaps due in part to the challenges associated with estimating the financial outcomes associated with different contract considerations. For example, how does the size of the evidence base impact the likely range of financial outcomes in a value-based contract? Our latest publication in Value in Health set-out to tackle exactly this issue.

Published: Systematic Review of Transportability & Generalizability Analysis
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.

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

Making Decisions Clearer: Target Validity & The Estimands Framework in Health Technology Assessments
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.

The Journey and the Destination: Process Measures for Diversity Action Plans
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.

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In December 2022, Health Canada released draft guidance on requirements for disaggregated data in new drug submissions.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.