06 Aug Keep our foot on the gas for clinical trial diversity

Broader representation can help address health disparities and improve patient outcomes.

By Jackie Kent, MedPage Today

The COVID-19 pandemic sparked rapid innovation and adoption of new methodologies and practices across clinical trials. It also allowed the world to see the difficulty of ensuring diversity and access to those trials — a challenge we’ve faced for many years. Innovators in biopharma, life-science technology companies, and clinical research organizations (CROs) partnered with the FDA and health regulators around the world to successfully meet this enormous challenge. But we need to keep our foot on the gas.

It’s time to press ahead with meaningful, durable change — to codify the lessons we’ve learned during the COVID pandemic, amplify what worked, and harmonize the regulatory environment to promote further progress.

We’re at a critical inflection point to continue ensuring that trials are designed for the correct population. Regulators have established stronger guidelines around the importance of clinical trial diversity and access — including the FDA, whose window for public comments recently closed on draft guidance to this effect. This guidance comes at an important moment. The pandemic illuminated the disparate health outcomes faced by marginalized communities, while also spawning major strides in patient diversity for clinical trials, a development that benefits both patients and research efficacy. Read more …