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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. The unit pioneered the streamlined 'mega-trial' approach and coordinates some of the world’s largest trials, which are uniquely positioned to inform doctors and patients about the efficacy and safety of a wide range of interventions.

We are 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. 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 30,000 patient REVEAL trial assessed anacetrapib, a CEPT-inhibitor drug that raises HDL cholesterol to a much greater extent than niacin, and results 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.

We 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. Results were published in 2018 and sub-studies are assessing the effects of aspirin and/or omega-3 fatty acids on cognitive function and eye diseases.

We coordinated the SHARP trial  which involved over 9,400 patients in 400 hospitals and 18 countries. The results demonstrated that lowering LDL cholesterol reduces the risk of atherosclerotic vascular disease in chronic kidney disease. The 850 patient 3C trial in UK-based renal transplant patients was one of the largest ever trials in this setting. Initial results showed that, 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



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