patients' satisfaction in clinical trials

EDITORIAL Patients' satisfaction in clinical trials Medical progress is dependent on new treatment or diagnostic protocols, new drugs or drug regimens. There is hope that the soon completed sequence of nucleotides in the human genome will generate a large number of potential new drug targets. This wealth of new information, as well as the sensitive nature of animal experimentation, may increase the need for clinical trials. The conduct of clinical trials requires adequate time to devote to the patients participating in the trial. However, clinical research is increasingly pressured by the demands on doctors interested in and capable of conducting clinical trials. It has even been debated whether there are enough clinical scientists and whether those who technically might be available are adequately trained. Although it is hard to define the ideal proportions between laboratory science and clinical science, the factors mentioned all work in the direction of potentially limiting clinical research [1]. Ethical considerations of clinical trials weigh the benefits and hazards the patients are subjected to. The trial should be motivated from a treatment or diagnostic perspective, but also scientifically, i.e. the increase of new knowledge. Patients are protected in the protocols approved by the ethical committees. Still, a clinical trial may induce discomfort or risks, particularly when the treatment principle is new and not yet investigated. There is an obvious risk that changes in the biomedical perspective as a result of the new developments in genomics and functional genomics will increase the demands on the competence of the clinical scientist. He/she may be enthralled by the enthusiasms expressed by the laboratory investigator, who is anxious to see his ideas tested, and not be aware of potential hazards in terms of side-effects. Likewise, competence in the ethical committees, which is essential for the responsible development of clinical science, needs continued attention. The recruitment of eligible patients for a clinical trial must obviously be based on a trustful relation- ship with the clinician. It is important that patients participating in a trial are representative of the patient population at large. It is therefore essential that the patients are adequately informed about the purpose of the trial and its predicted outcome in terms of new knowledge. Patient recruitment in clinical trials has been studied by several authors and reasons for declining to participate may vary from `no time' to `not interested'. A paper in this journal issue [2] analyses the level of satisfaction in patients who participated in two different clinical trials, a trial of interferon-2a versus a standard treatment with predinsolone in ulcerative colitis, and a study of MRI, a noninvasive imaging technique for the evaluation of inflammatory disease. The two studies typify a therapeutic and a diagnostic trial, respectively. The level of discomfort was significantly greater in the therapeutic study. Interestingly, the level of satisfaction was similar in the two groups. When asked what made them accept to participate in the trial the patients explained that their participation would increase medical knowledge and eventually lead to better treatment (either for personal benefit or for the help of others). Although most patients expressed un- realistic reasons for participation, all expressed satisfaction with becoming more informed and being better cared for. They also valued continuity (seeing one doctor). This is interesting information, which suggests that in a clinical trial a control or comparison group may not be comparable to the average treated patient. This bias is perhaps unavoidable, but certainly a caveat for clinical trials Journal of Internal Medicine 2000; 248: 441±442 # 2000 Blackwell Science Ltd 441

patients' satisfaction in clinical trials

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