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 my community’s willingness to rally around clinical trial programs. Most people I know with CF have participated in at least one, 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 insid me 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 invested in its employees in a long time. Of course, in this case, the employees are clinical trial participants. The pay is low despite the time required to participate in research and the growing number of trials that need participants.
From 2019-2022, 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-$8,000,
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 therefore leave products in the pre-revenue 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, though, 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 cystic fibrosis did not. My health saw explosive improvement overnight, making it clear I was receiving the medication, and not the placebo, during the study. 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 sadly passed away. 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. While the FDA says that pay is a recruitment incentive, the agency leaves questions around the amount to individual IRBs. The result is a wide variation in the governance over research participant pay, with IRBs operating independently of each other.
While the risk of coercion is certainly one 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 towards 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.