CTSU clinical trial follow-up service Privacy Notice

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.

Linkage of participants’ data by NHS Digital via the CTSU clinical trial follow-up service is only for participants enrolled into eighteen UK clinical trials for breast cancer, enrolling 1948-2003, which are no longer being followed up by their relevant researchers or practitioners. Follow-up information from up to 19,023 participants is still required to complete the data collection from these trials. Details of the trials can be found in the Appendix.

Long-term follow-up data from the clinical trials will be identified by NHS Digital using a linkage established with participant identity information provided by, or with the consent of the original trialists. This identity information may include name, date of birth, NHS number and address. Once the link is established with NHS Digital the CTSU Clinical Trial Follow-up Service will delete the participants’ identifiable information from their own database within three months. The new follow-up information from NHS Digital will then be supplied with a pseudo-identifier so it can be linked to the correct trial participant and added to the EBCTCG analysis database. The linkage will end when all participants are confirmed to be deceased or permanently lost to follow-up.

The follow-up information received from NHS digital can include date, type and site of cancer, and the hospital or GP where the cancer was registered. When a participant is deceased, the date and causes of death will be received.

The EBCTCG analysis database (which includes the information supplied by NHS Digital) will contain no personal identifiers. Importantly, whilst the information supplied is specific to each participant, no individual person will be identifiable in any publication arising from this work. Your personal data will not be shared with any third parties and will not be used for any automated decision making or profiling. If you would like to have this data withdrawn, please contact the study team using the details given below.

This study has been reviewed and approved by the South Central - Oxford C Research Ethics Committee, reference number 19/SC/0590.

More information about the EBCTCG project can be found at: https://www.ctsu.ox.ac.uk/research/ebctcg

Research is a task that we perform in the public interest. The University of Oxford, as sponsor, is the data controller. This means that we, as University of Oxford researchers, are responsible for looking after your information and using it properly. We will use the minimum personally-identifiable information possible.

The legal basis for the processing and storage of personal data for the CTSU Clinical Trial Follow-up Service is that it is ‘a task in the public interest’ (article 6 (1) (e)) and, that sensitive personal data is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes (article 9 (2) (j), based on Article 89 (1)).

Under Section 251 of the NHS Act 2006, we have permission to conduct this study without consent.

We have special permission to conduct the CTSU clinical trial follow-up service without study-specific consent (i.e. link, transfer, process and analyse the data) from the Confidential Advisory Group. This permission is given under Section 251 of the National Health Service Act 2006 and its current regulations, the Health Service (Control of Patient Information Regulations 2002) (CAG reference number: 20/CAG/0143).

What to do next?

If you decide you do not want your data to be linked in this way you can withdraw from this follow-up, without affecting your current medical care, by contacting the study team at the email address given below.

Data protection regulation provides you with control over your personal data and how it is used. When you agree to your information being used in research, [Where we have received special permission from the Confidential Advisory Group] however, some of those rights may be limited in order for the research to be reliable and accurate. Further information about your rights with respect to your personal data, specifically your right to lodge a complaint with a supervisory authority, is available at https://compliance.web.ox.ac.uk/individual-rights or by contacting our data protection officer at data.protection@admin.ox.ac.uk or the study team using the details below.

If you have further questions, please contact the study team at the following email address:

Email: bc.overview@ndph.ox.ac.uk