COTA’s Chief Medical Officer, C.K. Wang recently spoke at the 2022 Office of Human Research Protections (OHRP) exploratory workshop, Beyond altruism – Exploring payment for research participation. Here is a summary of his comments prepared by the OHRP and the Department of
Health and Human Services.
Panel Discussion 1
Dr. Wang added that recent research confirms both the importance of readable consent forms and after-trial planning in building and sustaining trust with subjects. Dr. Dickert reflected that the discussion suggests that trust is built or harmed within the larger context of interactions with the subjects of which payment is a part.
Session II: Practical Challenges and Implementations
It’s Not All about the Benjamins – Other Hurdles Presented by Research Participation, and
why Payment won’t Resolve Them
Dr. Wang gave several examples of hurdles to research participation that cannot be removed by payment. The first case study he presented was a 55-year-old Asian female from Laos with locally advanced carcinoma who was seen in the oncology clinic at her local safety net hospital. She was offered the opportunity to participate in a Phase III trial for which she was a good candidate. However, she had limited English proficiency and the consent form was available only in English, she lacked reliable transportation and access to communication, she was suspicious of the clinical trial mechanism, and she did not like the randomized nature of the treatment arms that offered no guaranteed access to potential treatment. Even when transportation issues were addressed by community allies, she ultimately declined clinical trial participation due to the number of required visits (labs, procedures, office visits) and the randomized nature of the trial.
A recent study cited by the speaker explored how remote technology and other tools for decentralization might be employed to overcome the burdens of time and travel, resulting in increased likelihood of enrollment in cancer clinical trials (Adams, Lon & Fluery, 2022). A cross-sectional survey was administered to cancer patients and survivors in the U.S. who had been diagnosed with or treated for cancer in the previous 7 years. The majority of 1183 respondents (60%-85%) reported that they were more likely to enroll if the participation-related time and travel burden decreased as a result of decentralization practices.
Dr. Wang noted that many novel trial designs are being explored today. He highlighted the use of Real-World Data (RWD) to construct a control arm, thereby replacing a traditional clinical trial control arm. All participants receive treatment. RWD could also help to contextualize trials by providing a better understanding of the intent-to-treat population and helping to enroll appropriate patients in trials.
Dr. Wang also stressed the importance of enrolling underrepresented racial and ethnic populations and cited FDA’s draft guidance on the development of diversity plan’s (2021). He noted that the guidance “sets a high bar” for research teams. The speaker suggested that the solutions to present-day challenges in achieving diverse participation in research may come in many forms.
Panel Discussion 2
Dr. Wang wondered whether the nature of the problems the workshop has explored stem in part from a misalignment of goals. Researchers want to develop a study that passes muster and gets funded, so they try to pack as much as they can into the study. Patients’ goals may be very different. The different perspectives can only be aligned through a two-way conversation.
Watch the full session here.