The NHS Breast Cancer Screening Age Extension Randomised Controlled Trial (RCT) continued during the Independent Review of breast cancer screening and even after the report (Marmot) had shown women were 3 times more likely to be harmed than to benefit from screening; it continues today, as the Parliamentary Inquiry into breast screening is being carried out.
Some concerns about the trial, key issues of Research Practice and Good Clinical Practice (GCP), have been raised on Healthwatch.org by Susan Bewley and Les Rose:
1 The research question
2 The trial personnel’s qualifications
3 Lack of informed consent
4 Little effective governance
5 Roll-out of the age extension, irrespective of the trial
6 The trial protocol
7 Difficulties accessing relevant information
8 No action on published cost-effectiveness analysis (Pharoah PDP et al) as recommended by Marmot
9 Investigator seemingly affiliated to sponsor
Healthwatch says, ‘These would be serious issues for an industry-sponsored trial. The Medicines and Healthcare products Regulatory Agency (MHRA) would not tolerate such a lack of governance’.
They end: ‘…here we have not only the largest clinical trial ever attempted, funded by the public purse, but it is being set up to support a public health policy for which there is doubtful evidence. Such a research programme should surely be subject to the utmost transparency, and be conducted to the most rigorous standards of quality and governance. But simple questions go unanswered, and oversight
Healthwatch says its aim is ‘to promote evidence-based healthcare’. The Home Page can be found at