Transparency, trust and minimizing burden to increase recruitment and retention in trials: a systematic review

Highlights oThe barriers and facilitators to trial participation from the patient perspectives are captured in the themes of ambiguity of context and benefit, lacking awareness of opportunity, wary of added burden, skepticism, fear and mistrust, building confidence, and social gains and belonging to the community.oTrials were perceived as an opportunity for some patients to access free and high-quality healthcareoPatients feared discrimination and inequities in accessing healthcare, particularly among patients from vulnerable ethnic minority groups, discouraged participation in trials.Study Design and Setting Systematic review of qualitative studies that reported the perspective of adult patients with any health condition who accepted or declined to participate in clinical trials.Results Sixty-three articles involving 1681 adult patients were included. Six themes were identified. Four themes reflected barriers: ambiguity of context and benefit - patients were unaware of the research question and felt pressured in making decisions; lacking awareness of opportunities - some believed health professionals obscured trials opportunities, or felt confused because of language barriers; wary of added burden - patients were without capacity because of sickness or competing priorities; and skepticism, fear and mistrust - patients feared loss of privacy, were suspicious of doctor's motivation, afraid of being a guinea pig, and disengaged from not knowing outcomes. Two themes captured facilitators: building confidence - patients hoped for better treatment, were supported from family members and trusted medical staff; and social gains and belonging to the community - altruism, a sense of belonging and peer encouragement motivated participation in trials.Conclusion Improving the visibility and transparency of trials, supporting informed decision making, minimizing burden, and ensuring confidence and trust may improve patient participation in trials.