Current Non-Monetary Sources of Motivation to Participate in Clinical Trials
The motivations of volunteers in clinical research are listed on the clinicaltrials.gov site; there is no treatment for their health problem or the treatments they have tried did not work or they may find out about new treatments before they are widely available, or they may contribute to the discovery of a treatment that could prevent a disease that is common in their family. For some, participating is a way to play a more active role in their own health care or they want to help researchers learn more about certain health problems.
These findings are largely supported by the results of the CISCRP (Center for Information and Study on Clinical Research Participation) 2017 study (1) which included responses from 12,427 individuals (a 10% participation convenience sample) from 68 countries.
Advantages and Perceptions of Clinical Trial Participation
Participation in a clinical trial generally offers the best quality medical care that might not be available to non-volunteers because it could be judged as excessive by their insurer. This type of extra care of course has value, and its cost is born by the trial’s sponsor This advantage is probably represented in the benefit line “may represent the best treatment option”, mentioned by 8.2% of volunteers in the CSICRP survey.
Clinical trial volunteers are usually held in high esteem by their health providers, something that makes them feel good. This advantage is probably represented in the benefit line “may receive more care and attention from physicians and staff”, mentioned by 4.1% of volunteers.
The CIRSCRP study also pointed to roadblocks, including knowledge gaps among the public, limited physician involvement in discussing clinical trials as treatment options, and the inconveniences that patients encounter after they volunteer to participate.
Factors for Enhancing Volunteer Experience in Clinical Trials
In his review of factors associated with clinical trials that fail and opportunities for improving the likelihood of success, Fogel lists items that could minimize volunteer burden and maximize appreciation (2): (a) easy to understand materials, (b) leadership and enthusiasm from the principal investigator, (c) an adaptable schedule (time and events) sensitive to volunteer’s constraints, (d) trial management software to send effective reminders about visits and protocol adherence via phone, text, or email, including supporting multiple languages in multilingual areas,(e) setting expectations appropriately and (h) providing appropriate empathy for any burdens that a volunteer is undergoing during a trial including those they cannot avoid, depending on the therapy and testing involved plus, as it may occur, the burden of perceiving that their condition is not improving.
Fogel also states that volunteers deserve to have (future) access to reports from studies in which they participate as this privilege increases the sense of being appreciated (and intellectually capable) and decreases the risk of dropping out. Yet, Ziv reported that, after completion, most studies are not available via open access (3).
Sponsors should wish for all their clinical trial volunteers to have the same reaction as Susan, a retired nurse in her mid-60s, who had been involved since phase I in the clinical program for tominersen, an antisense oligonucleotide for the treatment of Huntington’s disease. When she learnt that the program had been stopped, she was disappointed in the news but grateful for the care she had received as a clinical trial volunteer. “I’ve been so privileged to be part of this trial right since day one. Now it’s just about patience and reviewing. There’s no alternative, is there?” (4)
References:
1. Anderson et al. Global public attitudes about clinical research and patient
experiences with clinical trials. JAMA Network Open. 2018;1(6):e182969
2. Fogel, D. Factors associated with clinical trials that fail and opportunities for
improving the likelihood of success: A review. Contemporary Clinical Trials Communications, 11, 156-164 (2018)
3. Ziv, S. How to Design a Better Clinical trial with the patient Experience in Mind,
Newsweek, 2017 July 21
4. Kwon D. Genetic Therapies offer new hope against incurable brain diseases. Nature 592, 180-183 (2021)
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