Clinical Trial Diversity Isn’t Just a Moral Issue–It’s a Scientific Imperative

Inato's Liz Beatty pens an op-ed in Xconomy on the pressing need for clinical trial diversity.

To read the full article, visit https://xconomy.com/national/2020/07/27/clinical-trial-diversity-isnt-just-a-moral-issue-its-a-scientific-imperative/.

The lack of diversity in clinical trials is a serious problem that’s persisted for decades. Black Americans—who make up 20 percent of US multiple myeloma patients and are twice as likely to be diagnosed—have only accounted for4.5 percent of participants in multiple myeloma trials since 2003. Asian Americans—who make up nearly 6 percent of the U.S. population—have accounted forless than 2 percent of US-based trials.

The reality is that diverse patient populations have different responses to certain pharmaceuticals, and ignoring this poses a significant community and global health risk.

A critical reason behind this lack of diversity is the inherent difficulty in recruiting enough patients who statistically represent the population that makes up the disease; in short, the demographics of clinical trials don’t represent the demographics of the patient population. As such, regulators have made a series of well-intentioned attempts to rectify the problem.The FDA highly encourages and is tightening the reinson ensuring that clinical trials enroll racially, ethnically, and linguistically diverse patients, and Congress continues to work to pass laws intended to facilitate and encourage the FDA and industry to improve diversity in clinical trials.

Still, meaningful advancement has been minimal and the challenges that diverse populations face when it comes to participating in clinical trials remain.A study published in May 2019found that participation barriers continue to include mistrust, lack of comfort with the clinical trial process, lack of information about clinical trials, time and resource constraints, and lack of awareness about the existence and importance of clinical trials.

Furthermore, the continued lack of diversity in clinical trials is compounding long-held enrollment and execution inefficiencies. Case in point:Just 5 percent of research sites conduct 70 percent of clinical trials today, which means 95 percent of sites are underutilized in clinical trials.Twenty-five percent of cancer trials fail to enroll as many participants as they need, and 18 percent of trials close with fewer than half of the target number of participants after three or more years. As many as86 percent of clinical trials do not reach recruitment targets within their specified time periods.

A Marketplace Ecosystem is Essential for Democratizing Clinical Research

As a society, we’re having critical discussions right now about racial inequities and disparities that have long plagued this country. The clinical trial industry needs to do its part by ensuring clinical trial data is anti-racist and representative of all people. This is not only a moral issue; it’s a scientific imperative. Providers simply cannot properly treat diverse patient populations with new therapeutic offerings if they are unable to access adequate clinical trial data.

Creating an “exclusive” clinical trials environment that’s nearly impossible for new sites to penetrate results in dangerous harm to patients in desperate need of trial therapies. To be more inclusive, biopharma companies and clinical research organizations must make a commitment to access a wider range of clinical trial sites, providers and patients. Doing this means shedding inherent biases for conducting trials with “tried and true” sites, and expanding trial sponsorships to the vast majority of qualified and experienced sites that represent more diverse patient populations.

A marketplace ecosystem is the solution for creating greater visibility across a more diverse population of doctors and patients. By matching the most appropriate sites to the most relevant clinical trials, a marketplace model offers the ability to finally flip the broken, traditional approach of sponsors repeatedly tapping the same few doctors and research sites that typically represent primarily white, male patient pools. Furthermore, by empowering sites to apply to participate in trials that are most aligned with their interests and specific patient demographics, a marketplace ecosystem can allow sites—especially lower profile and untapped ones—to better promote themselves and gain access to a more level playing field.

We Need to Act Together, and Now

Collectively, the clinical trial sector needs to address its lack of diversity head on by employing a more accessible, transparent, marketplace-based approach — one that supports clinical trial data actually being representative of the disease in question. Now is the ideal time to make progress like we never have before. As an industry, we must collaborate and work together to diversify the pool of patients involved in clinical research and ensure all demographics are accurately and fairly represented in the years to come.

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