Despite recent efforts, major changes are still needed to properly prioritize participant diversity in oncology drug development and meet the White House's reimagined Cancer Moonshot goal of halving the cancer death rate in 25 years, according to several FDA officials and Big Pharma leaders.
While both private and public sectors have made diversity, equity and inclusion (DEI) pledges in recent years, racial and ethnic minorities and older adults are still underrepresented in clinical cancer trials, according to the American Association for Cancer Research. Now, the FDA's Oncology Center of Excellence Director Richard Pazdur, M.D., and leaders from Johnson & Johnson, Roche’s Genentech, Bayer and Moderna have aligned their voices to call for the sectors to unite.
To minimize the risks of new drugs and devices for all patients, a shift from retrospective DEI strategies to prospective, long-term approaches is required, the leaders wrote in an article published June 28 in Clinical Cancer Research.
The authors spelled out opportunities for sponsors to improve DEI across four key areas of drug development: institutional commitment, culture change and governance; clinical development strategy; setting enrollment goals to guarantee trial participant diversity; and development and implementation of operational strategy.
While they detailed actions to improve DEI in each category, Pazdur and his co-authors also highlighted areas that require the most immediate attention. Two of those action items were changes to historical clinical development designs and sponsor practices along with the need to train diverse and culturally competent clinical staff at trial sites.
The industry leaders—which included Janssen's vice president of oncology clinical development Craig Tendler, M.D., and Genentech's vice president of regulatory affairs Bea Lavery—also called on lawmakers to define which financial supports are allowable for patient study-related costs through legislation and regulation.
To undo decades of disparity in clinical trial participation rates, the authors claimed that financial reward systems from both the private and public sectors need to be redesigned to incentivize new behaviors.
To this end, they urged a public-private partnership that would combine funds and identify rewards around expanding equitable access to clinical trials. The alliance would help build consensus to address specific policy and regulatory issues, share best practices and avoid duplicative efforts, according to the authors.