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Challenges and opportunities in accessing trial data: an example from statin primary prevention trials
  1. Genevieve Umeh,
  2. Mark D Huffman
  1. Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
  1. Correspondence to Dr Mark D Huffman, Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, 680 N. Lake Shore Drive, Suite 1400, Chicago, IL 60611, USA; m-huffman{at}

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In 2013, the Cochrane Heart Group published an update to the systematic review of statins for primary prevention of cardiovascular disease (CVD). The objectives were to assess the effects, both harms and benefits, of statins in people with no history of CVD. Our results showed that statins reduced all-cause mortality (OR=0.86, 95% CI 0.79 to 0.94) and fatal and non-fatal cardiovascular events (RR=0.75, 95% CI 0.70 to 0.81) with no increased risk of adverse events (RR=1.00, 95% CI 0.97 to 1.03).1

Despite consistent findings of the benefits of statins for primary prevention of CVD, the validity of these results has been challenged by some authors.2 Observational studies have demonstrated associations between statin exposure and adverse outcomes,such as impaired cognition and dementia,3 but it is uncertain whether or not such relationships are causal given the non-randomised nature of these study designs. It is also uncertain whether these types of adverse events or other outcomes such as health-related quality of life, which was reported in only 2 of the 19 statin primary prevention trials as of 2013, were even collected in statin primary prevention clinical trials.

Since 2012, models have been developed to respond to calls for greater sharing of clinical trial data sharing from organisations such as the AllTrials campaign ( as well as the National Academy of Medicine4 and International Consortium of Medical Journal Editors.5 These principles for broader data sharing have garnered support from the Pharmaceutical Research and Manufacturers of America, the European Federation of Pharmaceutical Industries and Associations, the Biotechnology Industry Organization and even the United Nations.6 Data-sharing models include academic organisations serving as data hosts and intermediaries for requests, governmental institutions responding to information requests and pharmaceutical industry-sponsored sites where users can access trial data through secure platforms. New data-sharing models …

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