Cancer in adolescents and young adults

To the Editor: It has been claimed that patients are missing out on the most effective current treatments if they are not given an opportunity to enrol in clinical trials. Such statements are misleading and have the potential both to create concern in those without access to trials and to reduce the likelihood of true informed consent for involvement in trials.

Trials are, by definition, just that — trials. Treatment in the “innovative” arm(s) may result in worse outcomes. The finding that those involved in trials have a better outcome (eg, 5-year survival) may have numerous explanations. It is unlikely that the innovation is an adequate explanation for the finding — confounding factors such as selection bias, adherence to best current practice, and intensity of monitoring are more likely explanatory factors.

Furthermore, it is important to focus on other outcomes of therapeutic endeavour, such as quality of life, and the impact of the illness on other family members. Patients who live some distance away from tertiary referral centres or trial centres may have a greater adverse effect from involvement in a trial than other patients who live close to such centres.

Well designed trials are a crucial part of advancing medical therapeutics. However, the recent editorial by Cole1 and the article by Mitchell and colleagues2 in the Journal have been picked up by the news media as demonstrating that only through involvement in clinical trials can patients get best-quality care. It is not surprising that this is the way that the message has been received. The truth is importantly different. It is only through the conduct of clinical trials that best practice can be defined. However, patients anywhere in the country should be able to access current best-practice treatment even if they do not want to be involved in a clinical trial. Encouragement to participate in clinical trials should be based on arguments about the “greater good” and not about issues of quality of care. To use the latter as the basis for argument must be seen as coercion and as unethical.