Jeremy Chadwick, Head, Global Development Office
When we thoughtfully engage diverse populations in our clinical trials, we generate evidence that better reflects the patients and patient sub-groups most likely to use a medicine if approved, giving everyone more accurate data and insights to inform regulatory submissions, future trials, and, for approved treatments, potentially more efficacious and safer utilization. Enhancing diversity in clinical trials is simply the right thing to do.
Changes to the way the clinical trials are conceived, sites and investigators are identified, patients’ study experience and study accessibility have been long needed in order to achieve greater diversity in clinical trials and will enable the biopharmaceutical industry to better serve patients and support innovation. While acknowledging these shifts are overdue, we are pleased that a sea change is happening across our industry. Within just the past year, we have witnessed greater collaboration, resourcing and commitment for trial diversity and there is no going back.
Industry commitment is critical to addressing the systemic issues that deter or exclude many patients in Black and Brown communities, and in other underserved populations, from participating in clinical trials, so that those who want to participate, can. With this in mind, Takeda is proud to stand with our industry peers and PhRMA, and embrace these first-ever, industry-wide principles on clinical trial diversity, which will take effect in April 2021. The principles aim to:
With these principles in mind, Takeda and the broader biopharmaceutical industry commit to work with stakeholders including patients, patient advocacy groups, community groups, regulatory authorities, health care practitioners, academics and policymakers to define the systematic and impactful approaches that can enhance the diversity of clinical trial participants and help reduce health care disparities.
Karen Correa, Head, Global Clinical Operations