Current Monetary Sources of Motivation to Participate in Clinical Trials
Currently, offers of payment to volunteers participating in clinical trials come in three categories, reimbursement for-out-of-pocket expenses, compensation for time and burdens, and recruitment incentive. Reimbursement and compensation are service-based reasons for offering payment; recruitment incentives, by contrast, aim simply to improve participation rates. (1)
The payment guidance document from the Harvard Clinical and Translational Science Center (HCTSC), says that being motivated by payment to participate in research, even when someone would not otherwise have made the choice to participate, is not by itself concerning; payment only raises concerns when it threatens to distort decision-making and that IRBs concerned about undue influence should consider placing increased safeguards around informed consent (such as methods to ensure comprehension) as payment amounts increase.
The clinicaltrials.gov text concludes with the encouraging sentence: “Whatever the motivation, when they choose to participate in a clinical trial, they become a partner in scientific discovery. And their contribution can help future generations lead healthier lives. Major medical breakthroughs could not happen without the generosity of clinical trial volunteers – young and old.”
The question is: Could pharma sponsors be encouraged to see volunteers differently? Could volunteers currently recognized as generous scientific partners also be recognized and treated as business partners, in other words, as investors? Could clinical trial volunteers and the general public be encouraged to share this view? Could this radical change in attitude towards clinical trial volunteers improve participation rates?
Who are the current investors in pharma? Pharma employees from chemists and biologists to statisticians, data managers and regulatory experts are paid for their work regardless of the success or failure of the clinical research program. They cannot be viewed as investors. In most cases, trialists who implement clinical research protocols are also paid for their work regardless of the success or failure of the clinical research program (unless they are investors in the drug, a situation that arises when the trialist is also the inventor of the drug; a special case situation, with the possibility of a conflict of interest when recruiting volunteers, that needs to be disclosed to the volunteers and the IRB supervising the research). In general, therefore, only the sponsor’s shareholders (who own the rights to the drug being developed) can be viewed as investors. All the other participants in the pharma business are doing a paid job.
My position (which does not represent a consensus among Actu-Real management), is that volunteers, in a more equitable business world, should be treated as “investors” because they are indispensable partners in a risky business that currently provides delayed investment returns only to shareholders. This situation should be corrected out of a sense of fairness to the volunteers. This new relationship between the sponsor and volunteers could also be good business for the sponsor (and its shareholders) if the cost of “inviting” volunteers to the shareholders’ table is less than the cost of seeing clinical trials being unduly prolonged or abandoned for lack of participation.
In the next blog, I shall present the theoretical advantages and real difficulties of developing this new relationship, including non-trivial objections to such a plan.
1. Harvard Catalyst. (Harvard Clinical and Translational Science Center) Payment Guidance. Version March 26, 2018
Chief Medical Officer and Co-founder
Pharma industry veteran with 30+ years in large Pharma & in leading small biotechs, spearheading large initiatives and securing funding, psychiatry practice and research for 10+ years.