A Policy of Diversity and Inclusiveness in Clinical Trials: What it Means for African Americans with Cancer

Evan Hsiang

Abstract

African Americans with cancer face many challenges to their care. Clinical trials can offer these patients life-saving options, and their participation can provide researchers and clinicians with a better understanding of their disease and treatment strategies. Given today’s focus on targeted approaches, clinical trial participants can also gain access to more customized therapies uniquely designed for them. However, Black patients only represent 5 percent of trial participants despite making up 15 percent of cancer patients. 1 More needs to be done to connect them to current scientific studies. A diverse and inclusive policy strategy for recruiting these patients can lead to higher rates of enrollment in clinical trials and better overall outcomes.

Introduction

Clinical trials compare standard therapies to experimental ones, with the latter often producing better outcomes. In cancer, trial volunteers with locally advanced or metastatic solid tumors have benefited from this added survival. 2 However, African Americans seldom enroll in these investigations despite being greatly affected. For instance, Black patients make up 22 percent of Multiple Myeloma cases each year but only 4.5 percent of participation in these trials. 3 A lack of representation means a lack of understanding of factors that affect clinical outcomes. This is exemplified by the fact that researchers have not yet elucidated why Black women have more aggressive subtypes of breast cancer than white women. Given that African Americans disproportionately face adverse socioeconomic hurdles like less education and disposable income along with unequal access to health care due to inadequate insurance and distant treatment centers, boosting their trial involvement would require a careful consideration of how to tackle these historical impediments. 4 Abstract ideas of racial diversity and inclusiveness need to translate into action plans that include ease of access, administrative commitment, and race-conscious trial designs.

Bringing Trials to Patients

Compared to other kinds of patients, cancer patients are often sicker and require more complicated and costly treatments. Undergoing therapies as part of investigations only increases their burdens. Patients in studies face more questions and tests than non-enrollees in order to satisfy their trial requirements, and almost three-fourths of them live more than three hours from a trial center. 5 African Americans frequently experience even greater hardships than participants of other races. They may have to contend with fewer transportation options or limited available time off from work. 6 These factors contributed to a two-and-a-half-time hospitalization rate compared to white patients when the Covid-19 pandemic began. 7 However, Covid-19 did offer an unexpected benefit particularly for African Americans by accelerating the shift to virtual clinical trials. In 2020, as a result of efforts to decrease in-person interactions, patient access to trials decreased by 80 percent. 8 In response to this alarming drop, pharmaceutical executives had to change gears. Instead of forcing patients to travel to a few academic research centers for clinical trials, patients could participate remotely. Videoconference consent and monitoring along with at-home phlebotomy became common practices. Since 98% of patients liked this telemedicine approach, St. Louis scientists completed a remote study comparing fluvoxamine to placebo in Covid-19 patients. 9,10 Communicating by email, phone, and videoconferencing, they guided participants through self-assessments using equipment that had been shipped to their homes. According to McKinsey & Company, this decentralized recruitment strategy likely netted a more diverse pool of patients. 11

Administrative Commitment to Diversity

Diversity in trial participants can only come from leadership commitment to inclusiveness. Administrators can learn from past successes like the trials by the National Heart, Lung, and Blood Institute, which addressed high blood pressure, particularly for African Americans. 12 Led by Epidemiologist Thomas Ramsey in 2010, organizers considered race by intentionally featuring people of color in their brochures, posters, and newspaper ads. Patient questions were answered by nurses and physicians, many of whom were also people of color. This diversity recruitment led to minorities representing almost half of the 9,250 enrolled individuals.

Hiring more diverse recruiting staff also aids diversity in trials. Because of the racial homogeneity at institutions like the University of Wisconsin-Madison, where 80% of faculty are white, trial participants often receive explanations of scientific terms from white trial investigators. 13 Minorities may not trust their pitch or feel supported by their proposals. Having someone who may better connect with recruits makes a difference. The University of Alabama utilizes “lay community navigators” to link patients with trial investigators. Helping patients deal with their disease through education and guidance, these assistants are often more representative of the local population and may have a greater familiarity with the socioeconomic and cultural barriers facing their patients. 14 These efforts eliminated mammography screening rate disparities from 1999 to 2012. 15

Building trust with participants takes time, especially for African Americans who have collectively experienced experiments on slaves, forced sterilization, and the withholding of syphilis treatment. 16 With more diverse leadership and recruitment staff, African Americans can see themselves represented and feel more inclined to participate in clinical trials.

Changing the Design of Trials

If principal investigators set out to recruit patients of color, then more African Americans would join. For the immunotherapy drug Provenge that activates one’s own immune system to fight prostate cancer, pooled data from early trials suggested a higher survival rate for African Americans who received this therapy compared to Caucasians. 17 However, since the number of Black trial participants was small, scientists wanted to run a definitive trial with more patients. Appealing to community practices nationwide and making a concerted recruitment effort, they created a participant pool comprised of 12 percent Black men. Due to this outreach, they confirmed that Provenge conferred a 9.5-month survival advantage to Black men compared to white men. 18 Scientists can promote inclusive study designs through research and regulatory agencies. The National Institutes of Health now requires trial grant applications to demonstrate plans for recruiting minorities. 19 And American Society of Clinical Oncology researchers have proposed a minimum threshold of African American trial enrollment before a drug can receive FDA approval. 20 Moreover, since trials can inadvertently leave out minorities through exclusion criteria like body mass index or performance status, the FDA has recommended decreasing “unnecessary” exclusions to improve recruitment. 21

Conclusion

Cancer investigations enable scientists to evaluate differences in tumor biology, genetics, and physiology. While trial participants can improve their health outcomes and contribute to the development of new therapies, African Americans continue to be underrepresented in the enrollment of these studies. Virtual capabilities, diversity-conscious administrators, and inclusive trial designs can remove socioeconomic and distrust issues that lead to their decreased participation. Government agencies and cancer organizations can align researchers and their patients to close the gap in cancer outcome disparities. Trial enrollment increases today will save more lives tomorrow.

About the Author

Evan Hsiang is a student at Harvard College and a senior editor of the Harvard Health Policy Review.

References

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