In this exclusive interview, we sit down with Donna Libretti Cooke, JD, a distinguished clinical operations specialized consultant known for her extensive work in the pharmaceutical industry, including her time at Bayer. We’re delving into her innovative global mapping project, a pioneering effort to align participant payments with the evolving landscape of clinical trials. Join us as we explore the multifaceted challenges, innovative solutions, and forward-looking perspectives on participant compensation in clinical trials, all through the lens of Donna’s expert insights and strategic thinking.

Donna, what inspired you to initiate the global mapping project on participant payments, and what were your key findings?

Donna Libretti Cooke: I started this project at Bayer, driven by the realization that participant payments weren’t aligning with the evolving complexities of clinical trials. The project spanned numerous countries, assessing regulations and practices in participant payments. Not surprisingly, I found significant disparities and a lack of consistency, particularly in regulatory aspects. This highlighted the urgent need for standardization, where permitted per local regulations, and alignment with the complexities of clinical trials.

How do you ensure patient compensation for their time, effort, and inconvenience, especially from a global perspective?

Donna Libretti Cooke: It’s crucial to compensate participants for more than just expenses, but several countries restrict payments to just reimbursement for expenses and/or only permit them for Phase 1 Healthy Volunteer studies. While the the FDA and OHRP Guidance acknowledge compensation for time, effort burden, and inconvenience,   this isn’t uniformly seen worldwide. A striking example is the outdated mindset in oncology trials, where there’s a reluctance to compensate participants for time and effort due to an assumption of a lack of alternative treatments. To better ensure a fairer approach from a global perspective, organizations should host awareness calls and allow for open dialogue on what local regulations

Donna Libretti Cooke JD

do or do not allow. I encouraged countries to pilot a study to get Ethics/Health Authority feedback if the country had not tried the new approach. Some country colleagues were pleasantly surprised when local Ethics approved the payment plan. However, the discussions should not stop due to the evolving landscape of clinical trials. Continue the conversation and such pilots to help shift the perspective and recognize participants’ invaluable contributions to research.

Can you elaborate on the impact of industry collaborations and initiatives in shaping participant payment policies?

Donna Libretti Cooke: There’s a convergence of very active industry projects, like the SCRS Participant Payment Workstream, the Diversity Convergence Project’s one focus area for Fair Payment Strategies (initiated by CTTI), and LUNGevity’s Best Practices for Assuring Financial Neutrality for Patients that are aiming to shape participant payment approaches and policies significantly. Additionally, the 2022 National Academies Report recommended improving diversity by developing explicit guidance to direct local IRBs on equitable compensation to participants and their caregivers, including lost wages for lower socio-economic participants. These collaborative efforts aim to create guidelines and fundamentally shift the industry’s approach to participant compensation, focusing on diversity and fairness.

Stay updated with FDA guidance, EU CTR, other country regulations, and industry trends with the help of global clinical operations/regulatory colleagues. During my global mapping project, I learned that Belgium was starting a concerted effort to harness clearer guidance from their local Health Authority due to the trends they started seeing with approvals for loss of income. Such efforts should involve collaborating with Health Authorities, central IRBs, and regulatory bodies to ensure ethically and legally sound compensation strategies. It’s about aligning with evolving standards and best practices.

Moe Alsumidaie: How did you tackle the varied financial regulations impacting patient payments in your global mapping project?

Donna Libretti Cooke: There were clear rules in countries with strict financial oversight. However, in countries with ambiguous regulations, I encouraged trial teams to seek ethical committee approvals for innovative payment strategies. This approach led to successful implementations, showing the importance of adaptability in global trial operations.

How do you align participant payment budgeting with varied legal environments? Can you provide an example?

Donna Libretti Cooke: While the site budget development was centralized, the participant payment section often requires customization based on local regulations and practices. For example, in some countries, we modified budgets to separate reimbursements from payments for time and inconvenience, which allowed countries to eliminate a category if their local laws were strict in not permitting a particular payment category, thereby aligning with their local requirements. This ensures fair and compliant participant payments.

Finally, what are your expectations for the industry regarding participant payments in the coming years?

Donna Libretti Cooke: With the active industry initiatives mentioned above, I’m optimistic about the future, anticipating pivotal changes in participant payment approaches. Albeit in practice, my experience has been that some mindset shifts still need to occur. Nevertheless, organizations like LUNGevity’s efforts to date are quite impressive. This, along with SCRS and the Diversity Convergence Project, influences industry standards. I look to continue my passion for driving advancements to improve global access and eliminate financial barriers in clinical trials.

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Moe Alsumidaie Chief Editor
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.