2022 Trend: Clinical Trials are Becoming More Inclusive and Diverse

August 03, 2022
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Key phrase: Clinical trials are becoming more inclusive and diverse

Author: Rebecca Schlossberg

The biotech and clinical trial industry has for some time overlooked and ignored people of color, but recently that has started to change. The last decade has seen a lot of advancement in the pharmaceutical and biotech space, with thousands of revolutionary products being brought to market. Most of these innovations require thorough clinical trials to ensure it’s the safety and efficacy. Unfortunately, the majority of clinical trials enroll white patients at a higher rate than people of color. According to Yele Aluko M.D., the chief medical officer for EY Americas about 130 million Americans across various races are being deprioritized and ignored in clinical trials (LaHucik, 2021a). Not only are they not included in the trials but pharma and biotech companies assume that their drugs will work just as effectively in all people, despite not formally testing it across all ethnicities and races. Evidence has shown that side effects and treatment effectiveness is not universal across gender and race. It is crucial for drug makers to recognize that not all experiences will mimic those of the population they test, if the group being tested isn’t diverse.

Interestingly, it is not only the trial patients that are not diverse; the majority of site personnel at clinical trials are white. In academic and community hospital settings the staff, personnel, and on site investigators are a shocking 68% white. That number is lower in private practices, at 56% white (LaHucik, 2021). 

 

With this in mind, at the start of 2022 many in the industry have made a commitment to diversify their clinical trials through multi year efforts. For example, Novartis has set aside $13.7 million for clinical trials at three research centers at the Morehouse School of Medicine, a historically black college. Additionally, Abbott has also dedicated $5 million for the next five years to Howard University with the goal to diversify clinical trials. Another biotech company, Eli Lilly has made dramatic strides in this arena by addressing a lack of trust in medicine, establishing community partnerships, and reducing barriers of entry to boost minority enrollment in clinical trials. One area in which they are lagging is oncology trials, where black people only represent 11.5% of patients (Armstrong, 2021). The oncology field at large seems to be following this theme as seen across all clinical trials for cancer. In breast cancer, out of four new treatments that the FDA approved in 2020, the patient makeup was 2%-9% Black and 0%-9% Hispanic or Latino. Eli Lilly is working hard to address this concern and hopes that with the coming year they will do better. 

However, it is not only biotech companies who are making changes, regulatory agencies are also making efforts to encourage clinical trials to become more inclusive and diverse. For example, the FDA will no longer approve drugs when applications come to them without a diverse population in the trials. Just this summer, the FDA rejected Incyte’s PD-1 retifanlimab, for anal cancer, after finding that the trial had a lack of diverse participants among other reasons (Adams, 2021). 

 

As we enter into an era where clinical trials are becoming decentralized, ethnic and racial minorities will have more access to clinical trials enabling them to enroll in trials they previously did not have access to. Time will tell whether these changes will truly result in diversification and inclusion in the clinical trial space.

 

LaHucik, K. (2021, December 22). 2022 forecast: Pharma has the tools. Will clinical trials be less white in next year? Fierce Biotech. https://www.fiercebiotech.com/biotech/2022-forecast-calls-for-clinical-trial-diversity-aren-t-going-away-as-majority-studies

 

LaHucik, K. (2021a, November 23). Reify Health taps into renewed drive to improve clinical trial diversity, releasing new tool to give drug sponsors more insight. Fierce Biotech. https://www.fiercebiotech.com/cro/reify-health-releases-tool-to-give-drug-sponsors-insight-trial-diversity

 

Armstrong, A. (2021, September 20). Q&A: Eli Lilly is making strides in overall trial diversity, but oncology lags behind. Fierce Biotech. https://www.fiercebiotech.com/biotech/q-a-eli-lilly-diversity-oncology-clinical-trials

Adams, B. (2021, July 26). FDA deals blow to Incyte’s PD-1 retifanlimab after battering advisory panel meeting. Fierce Biotech. https://www.fiercebiotech.com/biotech/fda-demands-for-data-from-incyte-as-it-rejects-pd-1-retifanlimab-for-approval

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