CLINICAL TRIALS


touches on issues of equality and the elimination of disparities, which are core values of the field.


The bottom line is that in order to clinical trial participants need to reflect the populations who suffer from the disease being investigated. It is therefore important to include in drug development an accurate representation of the broad range of patients who will eventually receive the drug, including people of both genders, representatives of major racial/ethnic groups, and patients with a wide range of disease severity, concomitant illnesses, and use of concomitant treatments.


Causes of the Minority Gap in Clinical Trials


Trust, or the lack of it, is one barrier to increased participation. Many minorities have had less than excellent cultural experiences which have made them distrustful of authority figures. Minorities are thus often wary of sharing the most intimate details of their health in a clinical trial setting. Many minorities simply haven’t learned about the vital role these trials play in creating new treatments and cures.


There can be other concrete matters that hinder participant diversity. Sometimes trial materials haven’t been translated into a minority’s native language, or may be somewhat insensitive to their religious beliefs. Transportation to and from clinical sites can be prohibitively expensive or even unavailable for some potential participants, while others simply can’t afford to miss work. In addition, sponsors repeatedly run trials in large city hospitals, not small community hospitals that can’t support clinical trials, but where many minority patients seek treatment. Sometimes, doctors don’t invite minorities, making assumptions based on institutional bias, that all minorities lack funds, compliance, transportation, and a desire to follow through.


Finally, studies show that minority patients are more comfortable self- reporting to minority, rather than non-minority, doctors. Yet, in 2010, out of 13,000 oncologists, only 3% were black and 7.5% Hispanic, according to the American Association of Clinical Oncology.


Solutions to the Minority Gap in Clinical Trials


In addition to the FDA, other groups are coming forward to close the minority gap in clinical trials. Eli Lilly and The Center for Drug Development and Clinical Trials at Roswell Park Cancer Institute in Buffalo, New York developed a program in 2013 to train minority doctors to become principle investigators, based on the notion that recruiting minority physicians to care for minority communities will increase cultural comfort with clinical trials. The partnership has resulted in an annual 3-day workshop, “Reducing Cancer Disparities Through the Training of Diverse Workforce,” which trains minority oncologists in research and trial design for underserved populations in order to become principal investigators, with the intention to reduce cancer health inequalities among minorities. The program provides continued mentorship with the workshop faculty for participating physicians and, according to Vun-Sin Lim, M.D., research associate at Roswell Park, enhances collaboration among participants, who can pass their training on to other physicians. “The result,” says Lim, “is better patient care.”


The National Minority Quality Forum (NMQF) is also attempting to fill the diversity discrepancy. NMQF is a nonprofit research and educational organization focused on improving healthcare to high-risk ethnic populations by integrating data and expert initiatives to eliminate health disparities. “We have billions of patient records to help us understand who and where populations are that have diseases, and rare diseases that hit Americans,” says Gary Puckrein, Ph.D., president and chief executive officer. Between the years 2000-2014, NMQF collected data on how many people at specific ZIP codes had particular diseases,


such as diabetes, HIV, and hepatitis C, and who treated them. Sponsors can now use this data to help facilitate trial recruitment. In addition, NMQF and the Pharmaceutical Research and Manufacturers of America (PhRMA) launched “I’m In,” a national education program designed to engage underrepresented populations and communicate the value of clinical trials. This program also connects with prominent local figures and care providers to encourage minority patients to enroll.


Conclusion


The importance of diversity in clinical trial participants has been known for some time. Yet a minority, and sometimes a gender, gap still remains a major issue – a problem we can only expect to increase in magnitude as medicines become more precise and tailored to individual genomes. Increasing the participation of all minorities and women in clinical trials is vitally important in order to generate knowledge about new therapies and improve the generalizability of medicine. Increasing minority participation in clinical trials should be a top priority throughout the health care system.


Fortunately, steps are being taken by a variety of industry stakeholders in order to effectively close the diversity gap in clinical trials. But in order to close the diversity gap, we need more companies and public agencies to throw their weight behind initiatives like these. These steps will help the industry to more effectively develop medicines, to diminish minority health disparities and to achieve a stronger overall public health benefit.


References


1. Diversity in Clinical and Biomedical Research: A Promise Yet to Be Fulfilled. Published: December 15, 2015. Available at: http://dx.doi.org/10.1371/journal.pmed.1001918


2. Clinical Trials Still Don’t Reflect the Diversity of America. Posted December 16, 2015. Available at: http://www.npr.org/sections/health-shots/2015/12/16/459666750/clinical- trials-still-dont-reflect-the-diversity-of-america


3. Be a Champion for Clinical Trial Diversity. Bull, Jonca. Posted on June 14, 2016 by FDA Voice. Available at: http://blogs.fda.gov/fdavoice/index.php/2016/06/be-a-champion-for- clinical-trial-diversity/


4. US 2015 Census Data. Available at: https://www.census.gov/quickfacts/table/ PST045215/00


5. MONITORING ADHERENCE TO THE NIH POLICY ON THE INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH. Department of Health and Human Services National Institutes of Health. 2013 report. Available at: http://orwh.od.nih.gov/ research/inclusion/pdf/Inclusion-ComprehensiveReport-FY-2011-2012.pdf


6. Evelyn B, Toigo T, Banks D, et al. Participation of racial/ethnic groups in clinical trials and race-related labeling: a review of new molecular entities approved 1995-1999. Journal of the National Medical Association. 2001;93(12 Suppl):18S-24S.


7. Successful Strategies for Engaging Women and Minorities in Clinical Trials. The Society for Women’s Health Research United States Food and Drug Administration Office of Women’s Health. Published September 2011. Available at: http://www.fda.gov/downloads/ ScienceResearch/SpecialTopics/WomensHealthResearch/UCM334959.pdf


8. Where are all the female participants in Sports and Exercise Medicine research? Joseph T. Costello , Francois Bieuzen , Chris M. Bleakley. European Journal of Sport Science. Vol. 14, Iss. 8, 2014.


9. Do Women Have More Adverse Drug Reactions? Dr. Marius Rademaker. American Journal of Clinical Dermatology. Volume 2, Issue 6 , pp 349-351.


Sujay has over 20 years of experience with leading Silicon Valley software providers with a life sciences focus. Sujay was most recently Senior VP of Global Corporate Strategy and Development at Model N, where he filled multiple roles, from corporate development to overseeing their life sciences analytics and SaaS


business unit. Sujay started as employee #6 and was instrumental in the growth of Model N to 600 employees, over $100M in revenue, and its eventual IPO (NYSE: MODN). His career has also included strategy consulting at Booz Allen Hamilton, product strategy at CommerceOne, and general management roles at Singapore Telecom. He received his undergraduate degree from the University of South Australia and an MBA from Harvard University.


Pharmaceutical Outsourcing | 34 | November/December 2016


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