Original Paper How Do Doctors Explain Randomised Clinical Trials to their Patients? V.A. Jenkins, L.J. Fallow®eld, A. Souhami and M. Sawtell Department of Oncology, University College Medical School, Bland Sutton Institute, 48 Riding House Street, London W1P 7PL, U.K. As part of a larger study designed to improve doctor±patient communication in randomised clinical trials (RCT), we audiotaped the discussions between doctor and patient in which consent was being obtained for a RCT. This paper reports on 82 discussions conducted by 5 clinical oncologists in both District General and University Hospital outpatient departments. When introducing the subject of trials, uncertainty about treatment decisions was expressed by the doctors in the majority of cases (79, 96.3%). This was most often stated in a general sense (78, 95.1%), but some mentioned personal uncertainty (12, 14.6%), an approach which helps to maintain a trusting doctor±patient relationship. The word randomisation was mentioned in 51 (62.2%) consultations, although the process itself was usually described implicitly (78, 95.1%), e.g. by telling the patient that they would be allocated either one or other treatment. Analogies were used in 28 (34.1%) cases to describe the randomisation pro- cess. In addition, although treatments and side-eVects were described frequently, (68, 82.9%) and (72, 87.8%) respectively, information lea¯ets about the trials were not given to 23 (28%) patients. The study shows that U.K. clinicians adopt individual methods when providing information and eliciting consent to trials. # 1999 Elsevier Science Ltd. All rights reserved. Key words: clinical trials, randomised doctor±patient, communication, cancer, audiotape, informed consent Eur J Cancer, Vol. 35, No. 8, pp. 1187±1193, 1999 INTRODUCTION Randomised clinical trials (RCT) are an essential compo- nent in the validation of new cancer treatments. Low levels of recruitment are a major problem in some cancer trials and it is necessary to ®nd methods which will help to increase the recruitment of patients [1±5]. In the U.K. the recruitment rate is between 5 and 10% for all trials, with lowest rates for patients with common tumours, i.e. 1±2% for lung and 2% for colorectal [6]. These ®gures cause great concern as low or slow recruitment threatens the validity of the trial. It has also been suggested that patients involved in trials may have better clinical outcomes. Whether this is due to the treatment or the expertise of institutions and individuals committed to trials or other factors such as age and health status has yet to be established [7]. A number of factors have been identi®ed that hinder the entry of patients into trials. These are discussed in detail elsewhere [8±10] but can be divided into those aVecting the clinician and those aVecting the patient. The main diYculties facing the clinician include time pressures, no support staV, having to explain randomisation and obtain informed consent [8]. Giving complex information to patients about trials and describing the concept of randomisation in simple terms were the primary problems highlighted in a postal survey of 357 clinicians that established their attitudes to clinical trials of cancer therapy [11]. These communication diYculties were emphasised also by senior U.K. oncologists during commu- nication skill training courses [12]. The patients' diYculties include an overall lack of infor- mation, uncertainty about personal bene®t, poor compre- hension about the value of trials and an aversion to randomisation [9]. The concept of randomisation is a diY- cult one for many patients newly diagnosed with cancer to comprehend [13]. It emerged as a major barrier in a study that examined patients' attitudes to the randomised clinical trial [14]. Results showed that the majority of cancer patients (287, 91.1%) believed that patients should be asked to take European Journal of Cancer, Vol. 35, No. 8, pp. 1187±1193, 1999 # 1999 Elsevier Science Ltd. All rights reserved. Pergamon Printed in Great Britain PII: S0959-8049(99)00116-1 0959-8049/99/$ - see front matter 1187 Correspondence to V. Jenkins, e-mail: v.a.jenkins@ucl.ac.uk Received 25 Jan. 1999; accepted 18 Apr. 1999.