CTSU clinical trial follow-up service for EBCTCG

• Research type

  Research Study

• Full title

  CTSU clinical trial follow-up service with NHS Digital to provide de-identified follow-up data for use in the EBCTCG breast cancer meta-analyses

• IRAS ID

  261085

• Contact name

  Robert Hills

• Contact email

  robert.hills@ndph.ox.ac.uk

• Sponsor organisation

  Clinical Trials & Research Governance

• Clinicaltrials.gov Identifier

  MR360, NHS Digital reference

• Duration of Study in the UK

  4 years, 11 months, 31 days

• Research summary

  Many treatments for early breast cancer are likely to have only moderate effects; distinguishing between treatments that are beneficial, neutral or harmful requires large-scale randomised evidence and long-term follow up of the trial participants. The Clinical Trial Service Unit (CTSU) was set up in the 1980s to aid clinical researchers in designing, conducting and analysing the types of clinical trial that would provide this. One service offered was assistance in obtaining long-term follow-up of UK clinical trials through the Office of National Statistics. This service was used by researchers for their own analyses and for contribution of data to the Early Breast Cancer Trialists' Collaborative Group (EBCTCG) meta-analyses of clinical trials of breast cancer treatments.
  In high-income countries, the majority of breast cancers are diagnosed at an early stage when the disease can be removed surgically. Although most women with early breast cancer now survive, there is an ongoing need to identify which treatments are effective, which requires long-term follow up of the women who joined randomised trials, accurate data and efforts to minimise bias arising from the selective exclusion of eligible participants or trials from the analysis.
  Since the 1940s, there have been several hundred randomised trials of treatment of women with early breast cancer, involving several hundred thousand women. To understand this huge body of evidence, every few years starting in 1985, the EBCTCG has brought together all the evidence on the major questions for central meta-analyses of the anonymised individual participant data (IPD). It continues to do so, with an emphasis on large-scale randomisation and long-term follow-up. This 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. It provides a definitive summary of research findings that have accumulated over many years.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  19/SC/0590

• Date of REC Opinion

  18 Dec 2019

• REC opinion

  Further Information Favourable Opinion