Masahiro Hinoshita

Consent for Enrolment in Randomised Controlled Trials: a Questionnaire Study

Abstract Objectives: To test the hypothesis that the enrolment rate in a randomised controlled trial involving ‘malignant tumours’ would be lower than that involving ‘common illness’. Patients and Methods: Outpatients from oral and maxillofacial surgery clinics were requested to select from among the following 3 statements that which most closely reflected their attitude toward randomised controlled trials for a hypothetical common illness and a malignant tumour: “I may take part in a randomised controlled trial” (accept), “I will take part in a clinical study based on study conditions” (conditional), or “I will not take part in a randomised controlled trial” (refuse). Results: For common illness, 117 of 1083 participants (10.8%) selected ‘accept’, 664 (61.3%) selected ‘conditional’, and 302 (27.9%) selected ‘refuse’. For malignant tumours, 137 participants (12.7%) selected ‘accept’, 644 (59.5%) selected ‘conditional’, and 302 (27.9%) selected ‘refuse’. Among those who would refuse to participate in a randomised clinical trial for a common illness, 27.2% of patients selected “I will take part in a clinical study based on study conditions” or “I may take part in a randomised controlled trial” for malignant tumour. Conclusion: The hypothesis that the enrolment rate in a randomised controlled trial may be lower when patients are thought to suffer from malignant tumours than when they are thought to suffer from common illness is not justifiable.