Motivations and Burdens of Participation in Parkinson’s Disease Clinical Trials: Experiences from a Disease-modifying Phase 2 Study
Emily Tharp1, Juan Martinez Lemus1, Vanessa Thyne1, Chiamaka Onuigbo1, Tran Le1, Robert Ritter III1, Mya Schiess1
1Movement Disorders Division, McGovern Medical School at UTHealth Houston
Objective:
To assess the motivations for and burdens of participation in a clinical trial for Parkinson’s Disease (PD).
Background:
Clinical trials are essential for evaluating novel therapeutics and establishing evidence based clinical practice. Evidence from a 2020 review of 26 studies reports that perceived personal benefit and altruism are the most common reasons for participating in clinical trials. Evidence also shows that participation in clinical trials causes high physical and physiological burden in participants. These reports have not, however, included patients with neurological conditions.
Design/Methods:
Patients were enrolled in a Phase 2 clinical trial that compared rates of PD progression in intravenous allogeneic mesenchymal stem cell infusions and placebo (NCT04506073). After their final study visit, either one year following the last infusion or during their early termination visit, a participant feedback questionnaire was administered. Patients were asked to identify their top three reasons for participating in the study and their three least favorite aspects of participation.
Results:
Of the 49 participants that were given the questionnaire, 29 provided responses. Among responders, 62.2% were motivated by the potential improve of PD symptoms, 57.8% desired to contribute to science, and 57.8% wanted to help others with PD. The most frequently reported burdens of the study were undergoing lumbar punctures (LP), MRI scans, and traveling to visits, cited by 34.5%, 20.7%, and 20.7% of patients, respectively. However, 24.1% of responders denied any complaints about study participation.
Conclusions:
Consistent with prior data, the perceived benefits to self and/or to others were the primary motivators for study participation in PD patients. The physical burdens including LP and MRI were patients’ least favorite aspect of the study. Due to the discomfort of neurological diagnostic tools, the physical burdens of our clinical trials may be higher than that reported in other disease states.
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