A survey of the ethical considerations in randomised trials for lung cancer

In order to promote a more productive debate on the ethics of randomised clinical trials (RCTs), we present a survey on the ethical aspects of published RCTs for lung cancer.

Data from 92 published reports of RCTs for lung cancer, as identified from the Cancerlit 1993-1995 database were supplemented by a questionnaire mailed to the authors of those publications. The analysis focused on respect of autonomy, non-maleficence, beneficence, and justice as the ethical principles applicable to society, patients in trials, patients not included in RCTs and physicians. ETHICAL ANALYSIS: The benefits to society include an objective evaluation of new treatments. The principle of autonomy was often violated for patients who were inadequately informed about the disease or about RCT. In some trials with prolonged recruitment, the principle of non-maleficence was not fully respected since patients continued to be randomised in spite of an obvious advantage of one of the treatments. When compared to those not included in a trial, patients in RCTs were reported to benefit from more precise standards, superior quality assurance of diagnostic and therapeutic procedures, more attention from the physician, easier appointments and easier access to hospitalisation. However, these benefits diminish patients' autonomy and lead to injustice towards patients not included in the trials. While benefits to physicians were usually modest and in proportion to their contribution, an influence upon their autonomy cannot be excluded.

More attention to the aforementioned ethical caveats of RCTs should alleviate the ethical costs and might also bring more patients into future trials.