Amnestic MCI Patients’ Perspectives on Volunteer Participation in a Research Context

Abstract

Background: Inclusion of patients in research studies is immensely important when evaluating new biomarkers for Alzheimer’s disease (AD) and when the efficacy of possible treatment options is under trial investigation. If medical treatment is to advance in slowing the progression of AD, or even preventing it, voluntary participation of patients is not only important but also their reliable participation is key. To get closer in achieving this goal, researchers need to understand better what motivates research participants to enroll in a clinical trial and get insight into participants’ expectations about their participation. Furthermore, what researchers perceive as benefits and risks of a study can differ from participants’ view. This difference could lead to a situation in which researchers recruit fewer subjects than they expected or result in unreliable research subject participation.Method: We conducted semi-structured in-depth interviews in 38 patients with amnestic mild cognitive impairment (aMCI) as part of a clinical trial (EUDRACT no. 2013-004671-12) on the predictive value of biomarkers for AD. Patients had the option of receiving their Individual Research Results (IRR; visual binary read amyloid PET results). In this study, the motivations and perceived advantages and disadvantages of trial participation were investigated from the patients’ perspective. Before deciding to participate, patients received an information brochure describing the possible benefits and risks of participation.Results: The two most frequently mentioned reasons for volunteering for the trial were to contribute to scientific progress and to receive their IRRs. Participating to ameliorate scientific progress was not solely motivated by altruistic reasons; it was mostly mentioned along with the possibility of receiving a valuable result about their health condition, suggesting that self-interest also motivated patients to participate. The two most frequently mentioned disadvantages were the possible risks related to being subjected to invasive medical procedures and that volunteering was considered to be time consuming. Most patients felt that their partner and children supported their decision to enroll in the biomarker study.Conclusion: aMCI patients have several reasons for wanting to volunteer in a clinical trial, with the option of IRR disclosure being the primary motivation for enrolling. Most of our patients felt that family members supported their decision to volunteer. However, researchers need to be cautious when recruiting subjects for clinical trials by ensuring that they truly desire to participate in the study and those family members are not coercing them into doing so. In addition, what the information brochure mentions as possible benefits and risks of trial participation was not always perceived similarly by patients.