Scholars argue for regulatory changes to encourage paying trial participants for their data.
The billion-dollar drug development industry depends on data. Before entering the market, a drug must be extensively tested on humans through clinical trials. Researchers learn about the safety and efficacy of a drug by collecting medical data from trial participants. Despite pharmaceutical companies’ financial stake in this data, participants receive payment only for their participation in a trial—not their data.
In a recent article, Steve Calandrillo and several coauthors propose regulatory changes that would encourage research sponsors to compensate participants for data shared in clinical trials. The Calandrillo team argues that fair market value (FMV) payment for data “will improve the recruitment, retention, diversity, and fairness of clinical trials.”
Calandrillo and his coauthors state that a research sponsor, such as a pharmaceutical company, can fund a clinical trial. They explain that, although sponsors do not pay participants for their data, sponsors sometimes pay participants for their involvement in a trial. Such compensation depends on the trial’s time commitment and inconvenience to participants. According to Calandrillo and his coauthors, trial participants are not typically paid substantial sums. A study revealed that participants earn an average of only $4,000 per year.
U.S. Food and Drug Administration (FDA) guidance states that payment for participation in clinical trials must be just, fair, and receive approval from an institutional review board (IRB). According to the Calandrillo team, IRBs evaluate and grant approval to clinical trials based on a trial’s conformity with FDA standards.
Calandrillo and his coauthors argue that compensating participants for their involvement in a trial and not for the data they contribute fails to meet FDA’s “just and fair” standard. They claim that paying participants for their data would increase the fairness and equity of trial payments.
They assert that participants are unfairly uncompensated for the privacy risks they assume by sharing data in a trial. This financial injustice is exacerbated by the fact that non-participants profit by selling participant data, according to Calandrillo and his coauthors. They explain that technological advancements have led to an increase in the amount of participant data collected, reduction in the amount of time participants need to devote to a trial, and an expansion of participants’ exposure to data security risks; these factors combine to strengthen the case for paying participants for their data.
Calandrillo and his coauthors argue that, in addition to advancing equity, paying participants for their data will increase the diversity of clinical trials. They explain that racially and ethnically marginalized people, disabled individuals, senior adults, and members of the LBGTQ+ community are often underrepresented in clinical trials. They state that involvement in clinical trials can be costly for participants, especially those with less socioeconomic privilege. Monetary payments influence individuals’ decisions to consent to and continue involvement in a trial. Thus, according to the Calandrillo team, paying participants for their data will positively affect recruitment, retention, and diversity of clinical trial participants.
Calandrillo and his coauthors also assert that clinical trials lacking in diversity do not meet FDA diversity recommendations. They describe FDA’s 2024 draft guidance suggesting certain clinical trials have a “diversity action plan” that identifies a plan to meet enrollment goals for participants with “clinically relevant” demographics. Although they acknowledge the current Administration may have different priorities, Calandrillo and his coauthors maintain that non-diverse trials threaten the accuracy of research data.
The Calandrillo team proposes that payments to clinical trial participants for their data should be calculated based on fair market value (FMV)—that is, the “sale price agreed upon between buyer and seller.” Calandrillo and his coauthors explain that sponsors already negotiate with research sites to determine a FMV for the budget, including participation payment, for clinical trials. They advocate extending this standard industry practice to determine the financial value of participant data with a few considerations. They argue that the FMV calculation for participant data should consider the high quality and reliability of data generated in a clinical trial, the risk participants assume by sharing data in a particular trial, the degree of invasiveness of data collection, and the value of the data to the participant.
Calandrillo and his coauthors assert that the implementation of a FMV payment for participant data requires regulatory changes. They state that FDA and IRBs should collaborate to generate guidance for compensating participants for data shared in clinical trials. Calandrillo and his coauthors also recommend that the FDA issue guidance that “identifies payment for the FMV of data as a possible payment mechanism” for research sponsors to participants. They argue that, given the function of IRBs as evaluators of conformity with FDA standards, the review boards would likely only approve a sponsor’s FMV payment for participant data with specific FDA guidance.
The authors conclude that such regulatory guidance will better clinical trials and “even help accelerate pharmaceutical development.”
