By Allison Proffitt

May 7, 2019 | Patients, their caregivers, and advocates have become key contributors in the development of countless medical advances by providing their first-hand accounts to researchers, and even co-creating solutions based on their experiences living with a condition or disease. A group of pharmaceutical representatives, patient advocates, and researchers have released a call-to-action, advancing the conversation around fair compensation for this type of work.

The group, which included individuals from AstraZeneca, HealthiVibe, Janssen, Luck Fupus, Novartis, UCB Biosciences and more, recently released the fair market value call-to-action.

"Patient insights work" as the group calls it, includes, "a wide array of patient, caregiver, or advocate activities including online, telephone, or paper-based surveys; in-person or virtual focus groups, advisory boards, or long-term advisory panels; simulations; in-person or virtual in-depth interviews (IDI) or tele-depth interviews (TDI); co-creation workshops; and in-home ethnographic studies."

All of these efforts are meant to better incorporate patient feedback or experience into clinical research planning and design. And there's an emerging consensus that patients, caregivers, and advocates should be compensated for this work. The terms of such compensation, though, are not well-defined.

In the new Call-to-Action, the authors' goal is not to be prescriptive, but to, "contribute to the conversation on the integral issue of fair compensation for patient insights participants."

Fair Market Value

The call-to-action starts with a discussion of the fair market value (FMV) for time. FMV is well established for healthcare professional thought leaders and subject matter experts, they write. Charitable organizations often place a fair market value on volunteer time, represented as a financial contribution from individuals who give of their time and talents. But patient insight work isn't just serving non-profit organizations, it is often providing great value and direction for a for-profit industry.

"Many laws, regulations, and standards related to clinical research and trial participation require that fair market value for clinical research services be determined," the authors write, "therefore, it may be prudent for healthcare researchers to consider FMV for time and service toward participant insights work, too."

There have already been some suggestions and guidances in existence. For instance, The European Pharmaceutical Market Research Association suggests that participants be compensated, "no more than the FMV for that individual's professional consultancy or advice". In the U.S., the Food and Drug Administration (FDA) has acknowledged that for healthcare-related research, patient-participants may require compensation for their contribution, expertise, and time commitment.

The European Patients' Academy on Therapeutic Innovation (EUPATI), a joint consortium project between industry and the EU, issued guidance suggesting that compensation should cover at least time and expenses, and emphasized the importance of transparency and documentation of compensation arrangements and policies.

Compensation Models

The authors explore several compensation models, such as the wage payment model, which is one of the more frequently used. In this case, "payment is designed to be compensation for the time and contribution the participant makes to the research," they write. "Money offered to participants is calculated by a standardized hourly 'wage' offered to compensate for their hours of participation, with reasonable additions made for added inconvenience."

In groups already using a wage payment model, common themes emerge. In-person experiences earn the most, with in-home studies being the highest paid. Patient insights work that can be completed online or over the phone—surveys, for example—are paid at a lower rate. Compensation varies by geography, and by the outside expertise of the participant. Patients and caregivers may earn one rate, while a patient who has additional relevant technical expertise may earn a different rate. An individual may be paid a different wage from someone representing the collective views of a patient organization.

When calculating a fair standardized hourly "wage" to compensate patient insight participants for their time and energy, the group recommends considering the time commitment, complexity of the work, and the experience or expertise level of the ideal participant. Location should be considered to account for geographic variations. Reasonable adjustment can be made for any added inconveniences.

The authors acknowledge that the issue will remain challenging but say "strides toward compensatory alignment are being made" and encourage companies to consider examining their own patient insights work. "In partnership with patients, the medical and pharmaceutical research industries should work toward harmonization on this topic," they write.