Genentech paves path to increased clinical trial diversity as a ‘business imperative’

Genentech is aiming to lead the charge for clinical trial diversity in the pharma industry and it’s using a mix of regulatory commitments, trial site partnerships and community activism to get there.

Genentech has already filed 20 diversity action plans for Phase 3 studies with the FDA ahead of the agency’s final ruling, which it believes is the most in the industry. The FDA guidance is tied to the Food and Drug Omnibus Reform Act of 2022 (FDORA), which requires pharma companies to submit diversity action plans to the agency ahead of pivotal trials.

At the same time, the company is aiming to increase participation rates and establish reproducible best-practice trial sites.

It now has nine of what it calls Advancing Inclusive Research (AIR) Site Alliance clinical research center partners — six for oncology trials, and three for ophthalmology studies.

The result? Patients are enrolling two times…
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