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Randomized trials

CTSU’s main objective is the treatment and prevention of the major causes of death and disability worldwide, and our trials have largely focussed on cancer (particularly breast cancer) and cardiovascular disease. CTSU is distinctive in that it coordinates some of the world’s largest trials (having pioneered the streamlined “mega-trial” approach), which are uniquely positioned to inform doctors and patients about the efficacy and safety of a wide range of interventions.

CTSU is currently conducting trials in cancer, vascular disease, chronic kidney disease and other chronic diseases.

In cardiovascular disease, we are studying drugs which work through lipid modification, and our completed trials include the HPS and SEARCH, trials of LDL cholesterol reduction with statin therapy and the THRIVE trial of niacin/laropiprant, which raises HDL cholesterol modestly.  The results of the 30,000 patient REVEAL trial, which assessed the CETP-inhibitor anacetrapib, a drug that raises HDL cholesterol to a much greater extent than niacin, were published in 2017. The ORION-4 study is testing whether a new cholesterol-lowering injection safely lowers the risk of heart attacks and strokes in people who have already had one of these conditions, or who have had an operation or procedure to unblock their arteries.

CTSU ran the ASCEND trial to establish the effects of low-dose aspirin and fish oil on major vascular events among people with diabetes who did not have any prior history of vascular disease. ASCEND also tested the hypothesis that aspirin protects against the development of colorectal cancer, and other types of cancer, in people without known cancer. Sub-studies are being undertaken to assess the effects of aspirin and/or omega-3 fatty acids on cognitive function and eye diseases.

In chronic kidney disease (CKD), CTSU previously coordinated the SHARP trial (involving over 9,400 patients in 400 hospitals and 18 countries) which demonstrated that lowering LDL cholesterol reduces the risk of atherosclerotic vascular disease in CKD. More recently, CTSU has conducted the 850 patient 3C trial in UK-based renal transplant patients (making it one of the largest ever trials in this setting), the initial results of which have shown that, as compared to standard basiliximab-based treatment, rejection rates are more than halved by combining alemtuzumab with less intensive (and hence toxic) doses of a calcineurin-inhibitor (view Lancet paper). The EMPA-KIDNEY study is testing whether taking a single pill of empagliflozin every day prevents worsening of kidney disease or deaths from heart disease in people who have chronic kidney disease.

Data Access and Sharing

We welcome proposals from other researchers for collaborative projects involving our trial data. Sharing clinical trial data has become easier since we have adopted the use of CDISC standards (SDTM and ADaM) for our major clinical trials. We also publish detailed tabulations of our major trials on public websites (e.g. clinicaltrials.gov – see SHARP, THRIVE, and REVEAL, for examples) through extensive analyses of adverse event data published alongside the primary publications (e.g. THRIVE, REVEAL) or via links from our websites (e.g. HPS and SEARCH). 

Data from historical trials, which were managed using legacy systems (e.g. HPS and SEARCH), may require significant resource to robustly anonymise and make suitable for individual patient data (IPD) sharing and analysis by an external investigator. Consequently, it is more common for us to generate and provide the requested analyses rather than provide IPD for our older trials. Tabulations of serious adverse events for HPS and tabulations of serious adverse events for SEARCH

For enquiries about HPS and SEARCH please email data.access@ndph.ox.ac.uk.

The EMPA-KIDNEY study is currently active and recruitment is ongoing. Email enquiries for future collaborative proposals to data.access@ndph.ox.ac.uk.

The ORION-4 study is currently active and recruitment is ongoing. Email enquiries for future collaborative proposals to data.access@ndph.ox.ac.uk 

The SHARP data can be shared upon request in line with the data access policy (pdf). Please email initial enquiries to data.access@ndph.ox.ac.uk.

The THRIVE data are available in STDM and ADaM datasets and so would be available for sharing in line with the data access policy with relatively little additional resource required. Email initial enquiries to: data.access@ndph.ox.ac.uk.

The REVEAL study is still active and participants are being followed during post-trial follow-up. Email enquiries for future collaborative proposals to:data.access@ndph.ox.ac.uk

The 3C trial participants are undergoing follow-up through central registries. Email enquiries to data.access@ndph.ox.ac.uk.

The HARP-3 study data is available for sharing. Email enquiries to data.access@ndph.ox.ac.uk.

The BEST-D pilot study data is available for sharing in line with the data access policy. Email enquiries to data.access@ndph.ox.ac.uk.

The ASCEND trial has closed and results were published in August 2018. Data are not available for sharing at present. Please send enquiries about future collaborations to data.access@ndph.ox.ac.uk



Projects within this theme