Difficulty accessing data from randomised trials of drugs for heart failure: a call for action

Access to individual patient data from published research has the potential to improve patient outcomes by enabling researchers to answer new questions with existing data, to validate findings, and to combine the power from individual studies, for example in meta-analyses.1 It may also deter selective reporting and analysis, and research fraud. Difficulty accessing data from clinical trials means that only part of the evidence is available, which may lead to erroneous clinical decisions.

A survey of corresponding authors of clinical trials found that, although in principle they agreed with sharing their data, they also had concerns about appropriate data use, investigator or funder interests, and protection of trial participants.2 Sometimes data are not available because the trial was not published. For example, the Carcinoembryonic Antigen Second Look Trial in colorectal cancer was not published until over 20 years after completion and reported no benefit for the common use of carcinoembryonic antigen to detect and resect disseminated cancer.3 Barriers to accessing data have led to delays in determining the effectiveness or adverse effects of commonly used drugs such as oseltamivir, rofecoxib, and rosiglitazone.4 5 6

To make research data more widely available several journals and funders have published statements supporting data sharing for all published articles.1 7 8 9 10 The Association of Medical Research Charities (AMRC) in the United Kingdom, the European Medicines Agency, and the Institute of Medicine in the United States all recommend data sharing between researchers.11 12 13

Here, we describe our experiences trying …