Clinical trials - A brave new partnership?

Abstract

The need for informed consent is considered from the patient's viewpoint by an examination of the shortcomings of the UK Ductal Carcinoma In Situ (DCIS) trial and its failure satisfactorily to accrue both profession and patient. The impersonal, negative aspects of the informed consent process in the research situation are contrasted with the positive benefits of confidence fostered by the traditional doctor/patient relationship. The need for new research with a partnership between patient and profession, the necessity for rigorous re-assessment of treatments and care both within and outside of trials to avoid waste by the perpetration of unnecessary treatments together with the need for evaluation of the efficacy of treatments employed outside of trials, especially in 'new' conditions, to foster progress and maintain public confidence in the profession, is advocated.