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Can Paying More to Participants Increase Diversity in Clinical Trials?
(Thursday, January 12, 2023) A recent academic study found, surprisingly (pun intended), that paying people $500 to participate in a study that involved shipping self-collected blood samples to a lab and answering a short questionnaire, led to almost everybody participating compared to when no compensation was offered. The authors concluded that by offering higher compensation for participation, sponsors can increase the recruitment of poor and minority populations. The study seems like an obvious outcome study; of course, paying people a large amount of money for participating could coerce most of them to enroll, particularly if the cash offered means a lot to them, such as poor participants. This is not a new debate, but financial coercion is a major concern for payment to participants, particularly for clinical trials that might involve high risk investigational products. From the beginning of modern clinical trials, policies and laws have tried to address any forms of coercion, and financial coercion is the top of that list. Ironically, this was the major concern raised by governments of developing and poor countries in the last two decades when companies based in rich countries wanted to move their clinical trials there. Several regulations were placed in those countries to primarily protect participants from financial coercion. Coming back to the US, underrepresentation of minorities in clinical trials is no doubt an issue but bribing them to participate in clinical trials would open new wounds. It is important that the compensation offered to the trial participants be fair. IRBs need to carefully review the justification for the offered compensation for participation and monitor that the payment is devoid of financial pressures. Also, higher compensation will attract everyone, not just minorities and poor patients, which may create other issues, which the study did not address. For sponsors, it is important to follow FDA and IRB processes for payments to participants. This study could be used to rationalize the proposed payment to participants but there should be additional measures to assure that patients are not enrolling in studies that they would otherwise not enroll, financial pressures aside. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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