Clinical Trial Diversity Mandates Draw Drug Industry Resistance

The drug industry trade group wants Congress to back off mandates aimed at improving the diversity of clinical trial participants, even as it supports proposals to move these studies into community settings.

“Policies that would create additional mandates for sponsors would have serious unintended consequences of reinforcing rather than overcoming known barriers to participation for patients,” Lucy Vereshchagina, vice president of science and regulatory advocacy for the Pharmaceutical Research and Manufacturers of America, said in prepared testimony released ahead of Thursday’s House Energy and Commerce health subcommittee hearing.

Several bills among the 22 pieces of legislation on the health panel’s docket for Thursday aim to improve clinical trial diversity, which remains a pervasive challenge in clinical trials.

“As America becomes more racially and ethnically diverse, a clinical trial system that fails to enroll patients from growing demographics will not support the pace of innovation that will help us meet our potential,” Ruben Mesa, executive director of the Mays Cancer Center at the University of Texas Health San Antonio MD Anderson, said in prepared testimony.

“If we ignore this challenge, we will see trials that take longer and provide less reliable data. We will be less certain if a drug will help cure a certain group, or whether another group will have unexpected or severe side effects,” Mesa added. “And we will see more trials that fail to enroll enough patients to ever know whether a promising therapy is a breakthrough or not.”

The lack of diversity in clinical trials is a longstanding and well-known problem that policymakers and other stakeholders have attempted to improve for decades.

A 1993 law aimed to improve the inclusion of women and minorities in clinical research at the National Institutes of Health, but a 2018 study found NIH policies didn’t significantly increase reporting results by sex, race, or ethnicity. The 2012 drug user fee law also aimed to beef up reporting requirements as a way to improve clinical trial diversity in Section 907 of the Food and Drug Administration Safety and Innovation Act. And the FDA has taken a number of steps, including a 2020 guidance, to improve clinical trial diversity.

But a study published last year found many researchers still aren’t reporting their required demographic data, and that Black, American Indian or Alaska Native, Hispanic, and older adults continue to be underrepresented.

Legislative Solutions

The latest bills to tackle clinical trial diversity that the House subcommittee will consider include:

• Cures 2.0 (H.R. 6000), which includes several clinical trial diversity efforts, including revisions to Section 907, a government watchdog report, and public awareness campaign;
• The DIVERSE Trials Act (H.R. 5030), which would make it easier to use mobile technologies to decentralize clinical trials;
• The DEPICT Act (H.R. 6584), which calls on the FDA to issue regulations requiring enhanced data reporting on clinical trial demographics and providing resources to improve access to clinical trials; and
• The Equity in Neuroscience and Alzheimer’s Clinical Trials Act of 2021 (H.R. 3085), which aims to increase the participation of underrepresented populations in Alzheimer’s and other dementia clinical trials.

The hearing comes as Congress is deliberating legislation to reauthorize user fees the Food and Drug Administration collects from the industries it regulates to help fund agency operations. The current five-year authorization expires at the end of September, and many of the bills in the hearing are expected to be attached to must-pass user fee bills as policy riders.

Cartier Esham, chief scientific officer of the Biotechnology Innovation Organization, called for modernizing clinical trials that rely on digital health technologies and real-world evidence that decrease the burden on the participants to make multiple visits to the clinical trial site. Those approaches proved successful for Covid-19, “but companies currently lack a regulatory framework to leverage such techniques and tools fully.”

The biotech group also recommended that the Department of Health and Human Services conduct a series of public roundtable discussions to come up with recommendations for a more expansive and inclusive clinical development infrastructure, establish training for investigators serving underrepresented communities, and establish a publicly available database of community engagement organizations supported by the NIH.

Vereshchagina said stakeholders address these barriers to clinical trial participation by advancing community-based infrastructure focused on clinical trial diversity in underserved communities. But she warned that mandates will lead to “unfeasibly large and long studies,” while driving the drug industry away from working on risky therapies and ultimately delaying access to medicines.

“Improving clinical trial diversity is a critical component in broader efforts to address deeply rooted disparities across the U.S. health care system,” Vereshchagina wrote. “Making a meaningful change in clinical trial diversity requires all stakeholders including industry, patient and community organizations, medical providers, policy makers, and regulators, to work together to address the existing challenges.”

Tackling clinical trial diversity will ultimately take sustained attention and a willingness to act intentionally, Mesa said.

“There is no silver bullet for fixing the current lack of diversity in clinical trials. No single piece of legislation can finish the job and allow us to turn to other work,” Mesa said. “But the results would be life-changing.”