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How Much to Pay the Patients to Participate in Clinical Trials in the Pandemic
(Thursday, May 6, 2021) Paying patients to participate in clinical trials is common practice. Generally, these payments to clinical trial participants are justified to compensate for their time, inconvenience, discomfort, or some other considerations. Should a patient be paid higher for the increased perceived risk of visiting a clinic in the pandemic, or paid less because they are participating in a virtual trial where there are no visits, and the patients participate from the comfort of their homes? Payments to clinical trial participants are not regulated by the FDA; it is the responsibility of the IRBs to decide if the payment being offered to participants is justified. IRBs must weigh the coercive potential of the payment being offered compared to a reasonable compensation to support participants. In a pandemic, the perceived higher risk to visit a clinic for a participant has led to studies being closed, suspended, or severely limited. With more than a year of the pandemic related delays, sponsors desperate to entice participants in their clinical trials may want to offer higher payment for participation which could be perceived as financial coercion. This is particularly true where trials have been redesigned to add virtual elements to reduce site visits, remote data collection, and lower inconvenience to the study participants. On the other hand, increasing financial incentive may be needed to reinvigorate recruitment. It can also be argued that since the work and inconvenience for the trial participants is reduced, the payment offered pre-pandemic is already high. This is not a new issue as virtual clinical trials have always dealt with reasonable payment to participants. In virtual clinical trials, potential clinical trial participants provide data without the normal inconveniences seen in conventional site-based clinical trials. There are few or no visits to clinics, most observations are remotely collected, and in many cases, data is automatically collected without much effort from the patients. In virtual trials, the payments are primarily to incentivize patients above and beyond the compensation for additional work. So, if you are restarting your clinical trial in the post-pandemic world, you need to review the compensation models for virtual trials and add any considerations for your hybrid trials with a mix of conventional and virtual elements, to define a justifiable payment to the patients in your trial. IRBs need to carefully review those justifications to approve such payments. IRBs have been quite liberal with allowing payments for participating in virtual trials, they would likely approve increased payment for post-pandemic trials provided there is a reasonable justification. Payments to patients are not the only way to revigorated recruitment but it is an important one. The pandemic has changed practically all aspects of conventional trials, patient compensation included. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: mkumar@fdamap.com Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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