Who is taking part in ASCEND?
ASCEND involves the collaboration of many hospitals and GP practices throughout the UK. Diabetologists from around the UK have been invited to collaborate in ASCEND to allow the invitation of potentially suitable participants from their locally held diabetes registers Potentially eligible participants will also be identified directly from general practice.
Do you have Ethics Committee approval for ASCEND?
Yes, we have obtained research ethics approval for ASCEND from the North West Multi-Centre Research Ethics Committee (Reference MREC 03/8/087). Since local involvement is minimal, the North West MREC has indicated that local research ethics committees (LRECs) need only be informed and no formal local submission is required.
How were study participants identified?
People with diabetes were sought from 3 main sources: diabetes registers, trial databases and general practice. Hospital-based diabetologists and local GPs from around the UK were invited to collaborate by identifying potentially suitable individuals from their locally held diabetes registers. This approach has previously allowed large numbers of participants to be recruited by the Clinical Trial Service Unit into other studies such as the Heart Protection Study (HPS) and the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH), and is more efficient and cost-effective than mailings sent direct from individual centres or practices. Diabetologists and other collaborators were asked to identify local general practices with computerized diabetes registers, and to seek their agreement to invite potentially eligible individuals to participate.
Do you have approval to access diabetic registers?
The Patient Information Advisory Group (PIAG), set up under the Health and Social Care Act 2001 (covering England and Wales), gave approval for us to process patient-identifiable data from hospital registers (confidentially on behalf of local collaborators) in order to generate invitations to potentially eligible study participants.
(Note: PIAG no longer exists and it’s duties are now undertaken by the Data Access Advisory Group (DAAG) at NHS digital).
Does ASCEND have a CTA (Clinical Trial Authorisation)?
Yes - Aspirin (DDX number: MF/8000/13137) and Omega-3 fatty acid (DDX number MF/8000/13138). A Doctors and Dentists Exemption (DDX) was obtained for ASCEND prior to 1 May 2004. These DDXs will automatically convert to a CTA, but the CTA number is not yet available.
Who is coordinating this trial?
The Clinical Trial Service Unit (CTSU) at Oxford University is coordinating this study and will have overall responsibility for the administration and coordination of the study. There is a Steering Committee to oversee the trial conduct. The CTSU will be responsible for the training and monitoring of all staff directly involved in the study; for the supply of packaged study drugs and other study materials; for the identification (with the assistance of the local medical collaborators) of potentially eligible participants; for obtaining any relevant permissions to invite suitable patients to participate; for the initial invitation of participants and subsequent randomisation and follow-up by mail; for the provision of a 24-hour Freefone telephone service; and for the collection and analysis of data, and blood and urine samples.
How is ASCEND funded?
ASCEND is co-ordinated by CTSU which It is funded by the Medical Research Council, which supports an embedded MRC unit, as well as by grants from the British Heart Foundation and from Cancer Research UK. Funding for this study is provided by the British Heart Foundation to cover the administrative and coordination costs of the trial. Aspirin and matching placebo is being provided by Bayer Healthcare AG, and omega-3 fatty acid and matching placebo capsules by Mylan (previously Solvay Pharmaceuticals), with some funding from each company to cover drug packaging. Alzheimer's Research UK have provided a grant to measure cognitive fuction in ASCEND participants. The University of Oxford is acting as the sponsor of this study.