Clinical trials do not exist without us, so we need to demand more from them.
I am a strategist at a health tech company and also live with cystic fibrosis. While cystic fibrosis was historically known as a childhood disease, it is anything but that today. This is due in large part to my community's willingness to rally around clinical trial programs. Most people I know with cystic fibrosis 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 within the bounds of 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. 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 globally -- yet participant pay remains arbitrary and between studies. It's almost like mismatched supply and demand curves, where participants are in high demand but unwilling to participate.
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
of clinical trials fail to enroll on time, leading to costs of anywhere from and making trials take .
And yet it has been 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 the market faster and therefore reduce the amount of time products remain in the pre-revenue stage. The return on investment for study sponsors who increase participant pay should be clear from a business perspective.
From a patient perspective, even a marginal improvement in time to accessing new drugs is something worth celebrating. For patients, we pay the cost of delays 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 me feel confident I was receiving the medication (not the placebo) during the study. My friend went in the other direction. Soon after falling outside of 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 broader 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 that pay is a recruitment incentive, the agency leaves questions around the amount to individual institutional review boards (IRBs). The result is a 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 , patients have greater 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.
is a patient advocate living with cystic fibrosis and leads patient-facing strategy at , a clinical trial workflows platform.