CTT meta-analyses of adverse events (extension)
Research type
Research Database
IRAS ID
369423
Contact name
Christina Reith
Contact email
Research summary
Cholesterol Treatment Trialists' (CTT) Collaboration Database
REC name
South Central - Oxford C Research Ethics Committee
REC reference
26/SC/0066
Date of REC Opinion
3 Mar 2026
REC opinion
Favourable Opinion
Data collection arrangements
The Cholesterol Treatment Trialists' (CTT) Collaboration database previously included data from numerous randomised controlled trials of statin therapy. However, the data held did not previously include information on adverse events other than major vascular events, cancers and deaths, and so for the CTT to be able to address the pressing public health question as to whether statins cause additional effects required additional individual patient data on adverse events to be collected from trialists.
The sponsors and investigators of trials participating in the CTT were asked to provide pseudonymised data on the occurrence and timing of all adverse events recorded in their trials. A protocol describing the project was agreed by the collaboration and was published in 2016 (see: https://www.cttcollaboration.org/news/p) and the methods used to create the database were published in detail in 2022 (see: https://www.cttcollaboration.org/news/large-review-of-statin-clinical-trial-data-could-soon-end-remaining-uncertainty-on-possible-statin-side-effects).Research programme
There has been professional and public concern that statins may cause a wide range of side effects, resulting in significant numbers of patients at high risk of cardiovascular disease stopping statin therapy. However, these concerns arise mainly from non-randomized observational studies or reports, which are potentially subject to bias. The most reliable way to assess whether statins cause any adverse events is through meta-analyses of the data from the large randomized trials of statin therapy, which can be done by extension of the existing Cholesterol Treatment Trialists' dataset. This will result in a comprehensive understanding of the nature and magnitude of any other effects of statin therapy so that the balance of benefits and harms in specific types of individuals can be determined.
Research database title
Cholesterol Treatment Trialists' (CTT) Collaboration Database
Establishment organisation
Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), Nuffield Department of Population Health (NDPH), University of Oxford
Establishment organisation address
Richard Doll Building
Old Road Campus, Roosevelt Drive
Oxford
OX3 7LF