Part In Medical Research Research Articles

Testing a drug during labour: The experiences of women who participated in a clinical trial

Interviews were conducted with 104 patients who had participated in medical research involving pharmaceutical drugs. All patients were asked about the amount of information they had been given prior to being invited to participate, and about their understanding of, and satisfaction with, that information. Patients were also invited to comment on their reasons for having agreed to take part in medical research. Each had participated in one of 14 different drug studies. One of these studies involved a drug that was being used for the first time during labour. When analysing these data, it became apparent to the author that responses from some of those involved in the labour drug study were different from those of patients who had participated in the other studies. This paper compares the views of the 26 patients in the labour study with those of the 78 other patients. The women in the labour trial were generally less satisfied than patients in the comparative sample with the information which they had been given, and reported lower levels of understanding of that information. They had asked fewer questions about their study and reported lower levels of satisfaction with the answers they had received to those questions. This raises concerns as to whether the consent to participation given by women in the labour trial was in all cases fully informed. This in turn suggests the possibility of a gender bias in fulfilling ethical obligations in medical research.

Attitudes of patients to randomised clinical trials of cancer therapy.

The aim of this study was to test an instrument which might be useful for doctors in explaining the randomisation procedure to an individual patient. The sample comprised 323 patients with cancer attending for out-patient appointments and/or chemotherapy treatment in two major cancer centres in the U.K. 315 patients completed a self-report questionnaire--The Attitudes to Randomised Trials Questionnaire (ARTQ). The results show that the majority of subjects 287 (91.1%) believe that patients should be asked to take part in medical research, but only 242 (76.8%) would be prepared to take part in a study comparing two treatments. If treatment was randomised, only 141 (44.8%) would agree to participate. When given further information about the randomisation procedure, 119 (68.4%) of the 174 (55.2%) who initially said 'no' to randomisation or who were unsure, would change their minds and take part in a trial. The ARTQ discriminated between three categories of patient with the following prevailing attitudes: (a) those who seem comfortable with the concept of randomisation; (b) those with some concerns, who with fuller explanation are prepared to consider randomisation; and (c) those firmly against randomisation and participation in trials whatever information is provided. Prior knowledge of patients' attitudes might assist communication about trials and encourage more doctors to approach eligible patients.