On the tail of the FDA guidance on diversity in clinical trials, pharma companies are incensed to close racial disparity gaps in treatment.
A recent white paper issued by Trinity Life Sciences, a life science consultancy, sheds light on a critical disparity in pharmaceutical research: the lack of racial and ethnic diversity in clinical trials. This omission raises concerns about the effectiveness and safety of medications for minority populations. The report, titled “Diversity in Clinical Trials: Life Sciences Initiatives and Challenges in Light of the FDA’s Latest Guidance”, emphasizes a troubling gap between pharmaceutical companies’ acknowledgment of the importance of diversity and their actions to achieve it.
“For our literature review, we assessed company coverage of clinical trial diversity activities in the public domain,” explains Monique Marsh, Associate Director of Primary Market Research and lead author of the white paper. “We aimed to examine trends in current company engagement to understand how this landscape is evolving at an institutional level.”
The research paints a concerning picture. While over 40 percent of the United States population identifies as racial or ethnic minorities, according to the U.S. Census Bureau, their representation in clinical trials is woefully inadequate. “[We found that] only 5 to 10% of clinical trial participants represent any minority population,” the white paper addresses. This disparity can have serious consequences. Medications that haven’t been rigorously tested on a diverse range of people may have unintended side effects or prove less effective for certain populations.
Recognizing the gravity of the situation, the U.S. Food and Drug Administration (FDA) has taken action. In 2022, the FDA released draft guidance outlining strategies and plans to improve clinical trial participation from underrepresented racial and ethnic populations within the U.S. “[The FDA’s focus on this topic] with clearer guidelines coming into view, there has been a significant uptick in pharmaceutical engagement on the topic,” the paper states
While the industry is starting to take notice, the report identifies a concerning lack of transparency. “We see big pharma leading the charge with presentations and emphasis on company engagement in diversity,” the paper adds. However, the report goes on to state, “There’s a general lack of consistency in communication and transparency in company activities related to clinical trial activities.”
One company stands out for its commitment to transparency. “[GSK appears to be a leader on this front, reporting that 100% of its Phase 3 trials included a diversity plan at the end of 2022,” the report highlights. GSK’s dedication to providing details on its research and activities supporting clinical trial diversity, along with a roadmap for future work, sets a commendable example for the industry.
The lack of transparency isn’t the only hurdle. The report identifies several challenges that contribute to the underrepresentation of minorities in clinical trials. These include:
Historical abuses in medical research, like the infamous Tuskegee experiment, have left a legacy of skepticism, particularly among Black American communities. “[From our research,] 5 out of 15 executives explicitly mentioned that mistrust in the healthcare system remains a significant barrier to diverse enrollment in clinical trials,” the report reveals.
The inability to communicate effectively can lead to confusion and hesitation. “Language barriers often play a significant role in the lack of clinical trial participation amongst ethnic participants,” the report states.
Beyond these human factors, logistical challenges also play a part. Traveling for trial visits can be a burden, especially for those in rural areas.
The report highlights promising tactics that companies are employing to improve diversity in clinical trials:
Companies are creating dedicated positions focused on diversity, equity, and inclusion (DEI) efforts within clinical trials. “[One of the clearest efforts on the part of organizations is] the creation of senior level roles responsible for diversity, equity and inclusion (DEI) initiatives within trials,” the report emphasizes.
Utilizing telehealth appointments for trial follow-ups can significantly improve access for people in geographically remote areas. “Telehealth visits… are one of the most common (and reasonably easy) tactics biopharma has implemented,” the report acknowledges.
Traditionally, clinical trial eligibility criteria may have inadvertently excluded certain populations. “[Companies are] broadening eligibility criteria” to ensure trials are more inclusive, the report notes.
Looking ahead, the white paper emphasizes the need for greater transparency from pharmaceutical companies. “[The onus is on] pharmaceutical companies to proactively share results,” the report argues. By openly communicating their DEI efforts and the impact on clinical trials, companies can build trust and public confidence in their commitment to achieving greater diversity.
Trinity concludes the report with a hopeful outlook: “There is an opportunity for companies to catalyze change and evolve the dynamics of clinical development, but the industry must acknowledge historic challenges and approach this new environment with greater transparency and proactive engagement.” By acknowledging the problem, embracing transparency, and implementing effective strategies, the pharmaceutical industry can ensure that everyone has access to the best treatment.
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