CTT meta-analyses of adverse events
Research type
Research Database
IRAS ID
190579
Contact name
Colin Baigent
Contact email
Research summary
Cholesterol Treatment Trialists' (CTT) Collaboration Database
REC name
South Central - Oxford C Research Ethics Committee
REC reference
16/SC/0094
Date of REC Opinion
4 Mar 2016
REC opinion
Favourable Opinion
Data collection arrangements
The Cholesterol Treatment Trialists' (CTT) Collaboration database currently includes data from 27 statin trials among 175,000 patients. However, the data held do not currently 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 side effects requires additional individual patient data on adverse events to be collected from trialists and linked to the existing CTT data held for each trial.
The sponsors and investigators of trials participating in the CTT will be asked to provide data on the occurrence and timing of all adverse events recorded in their trials (together with the unique patient identifiers that will allow the new data to be linked to existing CTT records). These data will be supplemented by supporting materials that will facilitate interpretation of records and by supporting data on particular events. A protocol describing the project has been agreed by the collaboration and has been accepted for publication.Research programme
There is currently 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), University of Oxford
Establishment organisation address
Richard Doll Building, Old Road Campus
Roosevelt Drive
Oxford
OX3 7LF