Paying patients for participating in clinical trials and reimbursing the additional costs of travel, food, and caregivers, have always been subjects of heated debate. Emerging voices like Gunnar Esiason, a patient advocate living with cystic fibrosis and leading patient-facing strategy at Florence Healthcare, says that the discussion on the value that the patient brings to clinical drug development needs to start now. “I don’t expect this to change overnight, but it is time to talk about it,” he says.

Esiason knows first-hand what it means to participate in clinical trials. Over the last decade, he has spent more time in clinical trials than out of them. While money should not be an incentive for patients to participate in clinical research, it is an important aspect to value them for what they truly are—a finite resource that drives clinical trials forward. Often, the pay and reimbursement do not match the actual patient burden, if they exist at all.

Esiason shares with Clinical Trials Arena his case for increased pay in clinical trials, what the current regulations and laws are in the US, and who needs to lead the change for more equitable compensation.

Better pay for better recruitment and retention

One of the main benefits of increasing pay for clinical trial participants is improved recruitment and retention, which would eventually result in lower clinical trial execution costs, Esiason says. He explains that a clinical trial protocol can be seen as an employment contract because a person signs up a certain amount of their life for research. “I am not saying that participants should be seen as employees, but it’s a useful analogy,” he says. Improving those “working conditions” might help attract more attention from eligible participants.

Patient retention in a study can also be improved by increased pay. Esiason shares his experiences from participating in clinical trials, whether assigned to the placebo or active drug arm, where he would not notice health benefits. “I would wonder, why am I still doing this, if there are no changes in my health and I am travelling to the clinic for over an hour?” he explains.

While increased pay might not be the panacea to every single issue of recruitment and retention, it certainly could be one of the levers that are worth pulling to benefit the business, Esiason says. “There has to be some break-even point where increased pay enrols trials marginally faster. I think that the return on investment would warrant that discovery process,” he adds.

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It also can be used as a competitive advantage for certain sponsors. “Let’s say you are in a crowded therapeutic area, and everyone is competing for a finite number of patients with a small disease patient population,” he explains, noting that such an approach should be approved by a regulatory body beforehand.

Gunnar Esiason, a patient advocate living with cystic fibrosis and leading patient-facing strategy at Florence Healthcare.

US regulation and income caps

The issue is not just about the amount the participant gets, but also how that income will affect their access to healthcare benefits. Before the Ensuring Access to Clinical Trials Act of 2015, which made the Improving Access to Clinical Trials Act of 2009 permanent in the US, clinical trial pay was counted towards taxable income, putting people with rare diseases at risk of losing healthcare benefits, Esiason explains. “Policymakers realised this situation excluded a big and important part of the population from participating in clinical trials,” he adds.

Now, these patients can receive up to $2,000 without it being counted towards their income caps. While this was a huge win at the time, it does not match the current economic environment, Esiason says. “We’re living in a period of high inflation and the cost of living is going up. Why do we stop at $2,000?” he asks.

Even though trials are typically designed with that pay in mind, paying beyond that limit could risk excluding potential participants because of the concern around losing healthcare benefits, he explains. “I see raising the $2,000 cap as one of the initial steps towards raising participant pay more broadly,” he adds.

Who leads the change?

The change regarding pay increases depends on all the people involved in clinical research. Regulators need to open the door for the change, patients need to be at the centre asking for it, and sponsors need to be willing to make it happen, Esiason explains.

“Sponsors need to be able to do it knowing that the regulators have their back and allowing them on trial with increased reimbursement,” he says, noting that in the meantime, patients need to be loud about their participation experiences, as clinical trials do not exist without patients.

For the sponsors wondering how much a participant should be paid, Esiason advises them to start discussions with patients and patient advocate groups early. “As soon as [sponsors] are about to start their programs and advance their trials, they need to work with patient communities to actually understand what that patient needs, what endpoints should be measured, and what are the reasonable tasks a patient could do,” he explains.

Determining what’s ethical

There is still a debate around increased pay and coercion to participate in clinical research, Esiason says. The FDA outlines that small payments throughout the study can act as an incentive for completion and is accepted by the agency. However, sponsors need to prove that the “incentive is not coercive”.

Still, regulations and laws offer little guidance on what makes a payment ethically acceptable, and where the line is for undue inducement. He explains that while this might be true in some cases and there need to be controls around how to govern increased pay, patients usually make choices in their best interest.

Each therapeutic area needs to address these issues differently. In certain disease areas, like mental health or substance use disorders, cash might not be a correct way to entice patients to be more involved, Esiason says. Indeed, in some substance use disorder trials, participants receive vouchers at the completion of different milestones.

To ensure that the level of compensation that patients receive for participating in clinical trials is equitable and non-coercive, sponsors should discuss this issue with patient advocacy groups. “While patients have our best interest in mind, we need to have a central body, such as patient advocacy groups, to look out for us and understand the issue within the community,” he adds.