Drivers and barriers to patient participation in RCTs.

BACKGROUND: Recruitment of patients into randomised clinical trials (RCTs) is essential for treatment evaluation. Appreciation of the barriers and drivers towards participation is important for trial design, communication and information provision. METHOD: As part of an intervention to facilitate effective multidisciplinary team communication about RCTs, cancer patients completed two study-specific questionnaires following trial discussions. One questionnaire examined reasons why patients accepted or declined trial entry, the other perceptions about their health-care professionals' (HCPs) information giving. RESULTS: Questionnaires were completed by 74% (358/486) of patients approached; of these 81% (291/358) had joined an RCT, 16% (56/358) had declined and 3% (11/358) were undecided. Trial participation status of the 128 patients not returning questionnaires is unknown. Trial acceptance was not dependent on disease stage, tumour type, sex or age. Satisfaction with trial information and HCPs' communication was generally very good, irrespective of participation decisions. The primary reason given for trial acceptance was altruism (40%; 110/275), and for declining, trust in the doctor (28%; 12/43). Decliners preferred doctors to choose their treatment rather than be randomised (54% vs 39%; P<0.027). Acceptors were more likely to perceive doctors as wanting them to join trials (54% vs 30%; P<0.001). Trial type, that is, standard treatment vs novel or different durations of treatment, also influenced acceptance rates. CONCLUSION: The drivers and barriers to trial participation are partly related to trial design. Unease about randomisation and impact of duration on treatment efficacy are barriers for some. Altruism and HCPs' perceived attitudes are powerful influencing factors.