Attitudes to randomized clinical trials amongst out‐patients attending a medical oncology clinic

Abstract

Objective To assess the understanding of and attitudes towards randomized clinical trials amongst patients attending oncology outpatient clinics.Design Cross-sectional survey.Subjects Patients attending medical oncology out-patient clinics at a Sydney teaching hospital.Main outcome Patients' willingness to participate in a randomized clinical trial.Results Sixty consecutive patients were surveyed. The mean age was 55.2 (SD 14) years. Eighty-eight per cent of respondents thought that patients should be asked to participate in trials testing new treatments, however, only a third would consider participating in a randomized trial themselves. If a trial was endorsed by an independent cancer information service such as the NSW Cancer Council, 72% of respondents would be more likely to participate. Knowledge about randomized trials was not high. Respondents scored a median of 3 out of 7 (interquartile range, 2±4) correct answers to a series of questions about randomized trials. Patients willing to participate in a randomized trial were more likely to perceive the doctor favourably (P 0.05), less likely to perceive trials as experimental (P 0.05) and less likely to perceive trials as representing an inconvenience or loss of control (P 0.09).Conclusions Understanding amongst patients of the need for and mechanisms of randomized clinical trials is not good. This may contribute to the di culties investigators face in seeking consent for clinical trials. Evaluation of new strategies to educate the public and patients about randomized trials is needed. Involvement of consumers in the design and conduct of clinical trials and evaluation of strategies to improve doctors' communication of clinical trial information is also required.

Factors that influence the recruitment of patients to Phase III studies in oncology

“…This differs somewhat from the recommendations of many authors, who have suggested communication workshops and specific training for physicians who must discuss recruitment into clinical trials with patients. [27][28][29] Unfortunately, the results of such communication workshops have not been consistent. 30 For the relatively large group of academic oncologists at the HRCC who are involved in clinical research, communication skills may be relatively homogeneous.…”

Ethical communication in clinical trials

“…8 In an Australian study, 50% of clinicians surveyed were not participating in any trials, whereas a further 25% were participating in selected trials. 13 Various clinician barriers to recruitment have been identified, including lack of time and resources, patient characteristics that make some patients more difficult to approach than others, difficulties associated with obtaining informed consent and conveying complex information, and conflicts between the role of clinician and scientist. 8 Anxiety that disclosure of uncertainty may affect the physician-patient relationship also has been expressed.…”

Décision de participer à un essai clinique en cancérologie: influence du vécu sur les attitudes

“…Une association identique entre rô le actif et participation a dé jà é té observé e [17]. Toutefois, d'autres auteurs n'ont pas mis en é vidence une telle relation [7] ou ont observé une relation opposé e [6]. Ici, les patientes ayant refusé de participer semblaient avoir un profil suffisamment autonome pour pouvoir refuser de participer si elles ne le souhaitaient pas (par aversion pour la randomisation par exemple).…”

“…Toutefois, certains pré -fè rent dé lé guer la responsabilité de ce choix à leur mé decin [16] comme pour les choix thé rapeutiques en gé né ral [4]. Les rares é tudes disponibles ont montré des ré sultats contradictoires concernant le lien entre la pré fé rence pour le mode de prise de dé cision et la participation à un ERC [6,7,11].…”