Rallying Around Clinical Trial Programs

Nov 18, 2022 at 02:41 pm by kbarrettalley

Gunnar Esiason

By LYNNE JETER

 

For the last three years, clinical trials have grown by 25 percent, yet participant pay remains arbitrary and inconsistent among studies.

 

“It’s almost like mismatched supply and demand curves,” said Gunnar Esiason, a patient advocate living with cystic fibrosis and a patient-facing strategist at Atlanta-based Florence Healthcare. “It’s time to talk about paying clinical trial participants more.”

 

Esiason, who has been involved in several clinical trials, likens clinical trial participants to medical pioneers.

“Together, we step into medicine’s frontiers, but we do so inside a culture that dismisses the value of patients,” he emphasized.

Participating in a trial can be like working for a company that hasn’t invested in its employees in a long time, explained Esiason, whose role at Florence Healthcare entails working with internal teams to set product and market priorities and speaking externally to the market to advocate for closing gaps in clinical trial processes.

“Of course, in this case, the employees are clinical trial participants,” he said. “The pay is low despite the time required to participate in research – and the growing number of trials that need participants. 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.”

More than 80 percent of clinical trials fail to enroll on time, leading to costs of anywhere from $600,000 to $8 million daily and prompting trials to last twice as long. Moderately increasing pay has been shown to “motivate participation without being an unjust inducement,” said Esiason.

“In other words, patients are encouraged to participate–but not coerced to do so,” he said. “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, even a marginal improvement on time to accessing new drugs is celebratory. Patients pay the cost of delay with their health.

“In the latest trial that I participated in, I narrowly fit the inclusion criteria for participation, while a close friend with cystic fibrosis didn’t,” said Esiason. “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.” 

Patient compensation is typically based on the complexity of trials, independent of therapeutic focus, said Catherine Gregor, MBA, CCRP, chief clinical trial officer for Florence Healthcare.

“For example, CAR-T cell studies have a higher compensation than first-line chemo,” she said.

While the FDA acknowledges pay as a recruitment incentive, the agency leaves questions around the amount to individual review boards (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,” said Esiason. “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.”

With technology rapidly advancing to make trials more geographically accessible, it’s time the industry starts to treat patients according to what they are worth to increase trial access and participation, noted Esiason.

“A controlled increase in participant pay is a lever our industry and regulators should examine,” he said.

Even though inadequate pay for clinical trial participants has been an historical issue for decades, practical experience has shown a number of costs endured by participants are not compensated in traditional stipends, such as copays, lost wages, childcare expenses, et cetera, said Esiason.

“Questions have always been about how to justify the cost to sponsors in the budget and then how to make sure we are ‘compensating’ and not ‘incentivizing.’ Recent guidance from the FDA on inclusion and diversity in 2020 and 2022 suggests that sponsors and sites need to evaluate the use of compensation to reduce barriers to recruitment and level the divide in socioeconomic impact,” he added. 

Esiason emphasized his gratitude for the community’s willingness to rally around clinical trial programs.

“But clinical trials don’t exist without us, so we need to demand more from them,” he said.

Sections: Clinical



November 2022

Nov 18, 2022 at 03:06 pm by steve

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