Contributor: It’s Time to Talk About Paying Clinical Trial Participants More

Clinical trials do not exist without us, so we need to demand more from them.

I have cystic fibrosis (CF), a rare genetic condition that was historically known as a childhood disease. Today, CF is anything but that, and it’s due in large part to the community’s willingness to rally around clinical trial programs. Most people I know with CF have participated in at least 1, if not several clinical trials. I’ve been in a handful myself.

I like to think of clinical trial participants as medical pioneers. Together, we step into medicine’s frontiers, but we do so inside a culture that dismisses the value of patients.

The Problem for Patients

Participating in a trial can be like working for a company that hasn’t made a long-term investment in its employees. Of course, in this case, the employees are clinical trial participants and the pay is low despite the time required to participate in research and the growing number of trials that need participants.

From 2019 to 2022, the number of registered clinical trials grew by 25%—yet participant pay remains arbitrary and inconsistent between studies. It’s almost like mismatched supply-and-demand curves.

Increasing trial participant pay might be a path toward alleviating the participant supply crunch in trials hungry for patients. One key benefit of increasing pay for patients could be substantial: namely, speeding up clinical trials through a more competitive enrollment process.

The Consequences of Enrollment Delays

More than 80% of clinical trials fail to enroll on time, leading to costs of anywhere from $600,000 to $8 million per day and making trials take up to twice as long.

And yet it has been shown that moderately increasing pay can “motivate participation without being an unjust inducement.” In other words, patients are encouraged to participate—but not coerced to do so.

If increasing participant pay can accelerate trial enrollment, then a safe and effective drug can reach market faster and leave products in the prerevenue stage for shorter periods of time. The return on investment for study sponsors who increase participant pay should be clear to see from a business perspective.

From a patient perspective, however, even a marginal improvement on time to accessing new drugs is something worth celebrating. For patients, we pay the cost of delay with our health.

In the latest trial that I participated in, I narrowly fit the inclusion criteria for participation, while a close friend with CF did not. My health saw explosive improvement overnight, making it clear I was receiving the medication, and not the placebo. My friend, on the other hand, went in the other direction. After falling outside the trial’s inclusion criteria, she slipped into end-stage disease and died. She missed the drug’s approval by a matter of months.

Time matters not only for trial participants, but also the community of patients who rely on clinical trial outcomes.

The Need for Fair Participant Pay

The FDA’s guidance on pay has historically been vague. Although the FDA says that pay is a recruitment incentive, the agency leaves questions around the amount to individual internal review boards (IRBs). The result is a wide variation in the governance over research participant pay, with IRBs operating independently of each other.

Although the risk of coercion is certainly worth acknowledging, today’s patients have access to more information about their own health and investigational products than ever before. With scientifically sound resources at hand and a broad cultural shift toward patient-centered trial design, patients have plenty of opportunity to critically appraise trials before consenting.

Now that technology is rapidly advancing to make trials more geographically accessible, it’s time the industry starts to treat patients according to what we are worth to increase trial access and participation. A controlled increase in participant pay is a lever our industry and regulators should examine.

Gunnar Esiason is a patient advocate living with cystic fibrosis and leads patient-facing strategy at Florence Healthcare. Follow him on Twitter @G17Esiason.