What is broken at clinical research sites? This question posed at CORE East, a three-day intensive retreat produced by Halloran and held in Chatham, Massachusetts, sought to gather answers. In particular, the panel “Clinical Research Site Barriers: What’s Broken and Where’s the Opportunity?” led by Katie McCarthy, Chief Innovation Officer at Halloran, brought together industry experts to examine the clinical trial compensation model – one of the areas in need of improvement.
Panelists included Lora Parahovnik, President of Accel Research Sites Network, and Lindsay McNair, Principal Consultant at Equipoise Consulting.
The problem is that high compensation may serve as undue inducement to participate, while low compensation or reimbursement often leads to patient dissatisfaction and dropout. So, where is the appropriate middle ground?
In this article, we’ll review trial compensation models, summarize FDA’s latest information sheet on payment and reimbursement, and offer suggestions shared during the panel to move towards a better clinical compensation approach for trial participants.
Clinical Trial Compensation: A Brief Overview
Compensation in clinical trials can mean two distinct outcomes – when participants receive monetary or other benefits for their participation in the clinical trial. While this model is an established practice, to this date, we are yet to reach any consensus about the right way of going about compensation or whether it should be practiced in the first place.
Compensation is paid for reasons like relieving participants of financial sacrifice, acknowledgment of their time and effort, a token of appreciation of the participant’s contribution to medical science, for achieving adequate recruitment in the required time, and more, including cases of trial-related injuries.
There are several proposed models of making payments to clinical trial participants. The common models include:
FDA on Compensation Models
In 2018, the U.S. Food and Drug Administration (FDA) released a final information sheet on “Payment and Reimbursement to Research Subjects.”
The FDA maintains that paying research participants in exchange for their participation is a common and, in general, acceptable practice. But the agency also recognizes that payment for participation may raise difficult questions that should be addressed by the Institutional Review Board (IRB).
The amount and schedule of payments should be presented in the clinical trial protocol to the IRB at the time of initial review. The IRB should review both the amount of payment and the proposed method and timing of reimbursement to assure that neither are coercive or present undue influence.
While the entire payment should not be contingent upon completion of the entire study, payment of a small proportion as an incentive for completion of the study is acceptable to the FDA, providing that such incentive is not coercive.
Ethical Considerations
From an ethical perspective, when the IRB approves a clinical trial protocol that includes the amount and schedule of payments, they do so based on alignment with specific criteria. For example, they will review the risks compared to the benefits of the study, and whether those benefits are towards a participant or the scientific knowledge resulting from the study.
If the IRB has decided that a protocol is reasonable, the risks are reasonable, and participants can enroll in the study, then offering to pay them for their time and being part of the study does not change the risks and is also considered reasonable.
But what is, truly, reasonable and fair? How much is enough? Our industry still has a way to go to gain complete alignment. But it starts with understanding regulatory and ethical boundaries, getting to know your patients before they enroll in the trial, understanding what is meaningful to your patients based on their time and efforts to participate in the study, and then compensating appropriately based on their burden and their contribution to the study.
If you are struggling with your compensation model in your clinical trial protocol or preparing for your IRB review, contact us today. We are here to listen to your challenges and offer solutions.