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The Early Breast Cancer Trialists’ Collaborative Group (EBCTCG)

The EBCTCG overview is a series of IPD meta-analyses. The project includes women diagnosed with operable breast cancer (or breast cancer which might become operable through the use of pre-surgical therapy) and enrolled on randomised trials comparing treatments for breast cancer, with recurrence or death as a principal outcome. Meta-analysis of results from randomised trials of the treatment of women with early breast cancer provides reliable and robust evidence to inform the thousands of decisions about the management of breast cancer that take place every day around the world.

The women who joined several important UK clinical trials included in the EBCTCG overview are no longer being actively followed up by the researchers who recruited them, or by their practitioners, for the outcomes measured for the original trials or those needed for the EBCTCG meta-analyses. Therefore, the only way that these participants’ outcomes can be collected and added to the EBCTCG analyses is by linkage of their medical records via the NHS, by their information processing service, NHS Digital. If this is not done, the data on the women who agreed to join these trials will not be able to continue to contribute to the meta-analysis of long-term follow-up, and this opportunity to evaluate the long-term harms and benefits of treatment in a cost-effective way will be wasted.

The protocols of most of the randomised controlled trials included in the EBCTCG overview would require participants to give informed consent to long term follow-up of their treatment outcomes, including details of disease recurrence, adverse effects and death. However, in the earliest clinical trials for breast cancer treatment, explicit consent for long-term follow-up by data linkage was not sought at the time of randomisation. In circumstances such as this we can seek permission from the NHS Confidentiality Advisory Group to link, transfer, process and analyse the data without the knowledge or consent of the participants.