Editor—Lilford suggests that indicating to a patient offered entry to a clinical trial that the best treatment was unknown suppresses sophisticated questioning on behalf of the patient.1 I believe the opposite to be the case.
As a clinician active in recruiting older patients to randomised trials assessing the role of breast radiotherapy, I have found that patients carefully weigh up the risks and benefits of treatment in each trial arm.
There is great diversity in the response of patients to the offer of entry to a clinical trial. Often the prospect of admission for 4-6 weeks for radiotherapy and separation from family deters older patients from attending for treatment. For other patients the small risk of serious radiation induced complications dissuades them from trial entry. Conversely, some patients elect to have radiotherapy even if the reduction in the risk of recurrence of breast cancer may be small.
Many patients debate these issues with other healthcare professionals such as breast care nurses and their general practitioner before coming to a decision. In addition, ethics committees pay close attention to ensuring that patient information sheets accurately reflect the state of knowledge about treatment options and their risks and benefits. All these avenues of consultation encourage patients to make fully informed choices about trial entry.
Competing interests: None declared.
References
- 1.Lilford RJ. Ethics of clinical trials from a bayesian and decision analytic perspective: whose equipoise is it anyway? BMJ 2003;326: 980-1. (3 May.) [DOI] [PMC free article] [PubMed] [Google Scholar]