Editor—Lilford uses the example of the ProtecT study to raise concerns about recruitment to clinical trials, taking quotations out of context from Donovan et al.1,2 Lilford asserts that in this study men are simply told that the best treatment for localised prostate cancer is “uncertain” that they are not given enough information or time to question the recruiter about essential details about treatments and side effects; and that they are not given sufficient clinical information about their disease. None of these assertions is true, as we argue on bmj.com.3
The ProtecT trial has been subject to extensive peer review and is conducted according to MRC guidelines for good clinical practice, with scrutiny by steering and data monitoring committees and the NHS research and development health technology assessment programme. Outside the trial a patient's choice of treatment is influenced by personal preference, the media, and recommendations by potentially biased clinicians.4,5 Within the trial we are committed to providing accessible, balanced, and comprehensive written and oral information about prostate cancer. Participants are encouraged to express and discuss their views, being given ample time to reflect before making the decision to join the trial or choose their treatment.3
Lilford's statements about what is “unknown” and “uncertain” in relation to prostate cancer are vague, confused, and misleading. Within ProtecT we give precise information on the risks and benefits of treatments, based on current evidence, for particular tumours. The ability to prolong survival and improve quality of life in localised prostate cancer is uncertain, with choice of treatment particularly difficult because of the balance between potential for cure and overtreatment. In this well informed context, randomisation often provides a solution to the dilemma of decision making.
Lilford's assertions about the conduct of ProtecT are inaccurate and unjustified. We utterly refute that we are “glossing over the ethical complexities” and using “misleading” language.1 In the ProtecT study well informed patients and dedicated clinicians, nurses, and trialists are working together to provide robust and ethically based evidence, so urgently required in the management of prostate cancer.
FCH, JLD, and DEN are principal investigators and JAL is coordinator of the ProtecT study.
Competing interests: None declared.
References
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