Abstract
BACKGROUND: Physicians' perception and attitudes towards a research topic and trial management could influence their participation in a randomized controlled trial. The objectives of this study were to determine the reasons for physicians' participation in and attitudes towards the Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) trial. METHODS: CASE-J's main objective is to compare the effectiveness of an angiotensin II receptor antagonist (candesartan cilexetil) with that of a calcium channel blocker (amlodipine besilate) in terms of the incidence of cardiovascular events among high-risk hypertensive patients. We conducted a questionnaire survey among the physicians (n = 512) participating in that trial to determine the reasons behind their participation and to elicit their reactions to the trial management. RESULTS: Eighty-eight percent of the 512 participating physicians responded to our survey. The main reasons for participation were clear objectives of the trial (85.1%), a simple protocol (61.1%), interest in finding out the inhibiting effects of the drugs on cardiac events (80.2%), and a well-organized support system (59.8%). As for negative factors, case registration and follow-up were considered cumbersome by 28.6% and 10.8%, respectively while 44.2% stated that support by the clinical research coordinators provided by the trial management authority was necessary for case screening, recruitment process, patient registration, and follow-up. Multivariate logistic regression analysis showed that participants who did not use a computer very regularly (odds ratio = 1.9, 95% confidence interval = 1.1-3.6) were more likely to consider the case registration and follow-up procedures as a cumbersome. CONCLUSION: The information generated by this study could be useful in designing future randomized controlled trials in Japan and abroad.