By Aaron Krol 

October 21, 2014 | In May 2013, GlaxoSmithKline launched a system for sharing its raw, patient-level clinical trial data with outside researchers, including data on trials reaching back to 2007, in a first-of-its-kind trial transparency initiative for the pharmaceutical industry. Other pharma companies soon joined the program, including several in the top ten: Novartis, Roche, Sanofi and Lilly have all signed on to disclose their future trial data through the system. Researchers can apply for data access online, and their request will be processed by an independent review board — with members at this time appointed by GSK.

Now, the four initial members of the review board have published an open access article in the New England Journal of Medicine, explaining their role and describing the progress of the trial transparency program to date. The authors write that their default position was to allow access to data, without considering the scientific merits of a given request. “However,” they add, “the committee was also tasked with screening for ‘rogue reanalysis by nonexperts or by analysts who have conflicts of interest,’ analyses by teams lacking the skills to perform such analyses, and analyses without accompanying plans for disclosing the results publicly.”

According to the authors, the review board has approved 36 requests for clinical trial data since the system’s launch, with the largest approved request retrieving data from 11 different studies. Researchers using the program have outlined projects to search for novel biomarkers and risk factors in large patient populations, to compare the efficacy of different treatments, and to use retrospective data to create and refine new data analysis methodologies.

Moving forward, the authors recommend that a new independent panel, separate from GSK, be brought together to manage the trial transparency system as new pharma partners are added. They also suggest that academic researchers overseeing studies of large patient populations place their data in the same system, to encourage data aggregation. “Some of us believe that all clinical trial data should eventually be put into the public domain for unconditional, universal access,” the authors conclude, “but we see the current initiative as an important, swiftly implemented, and successful first step.”

At present, the large majority of studies included in the system still come from GSK, which has made data from roughly 950 trials available and is steadily adding studies dating back to the company’s formation. Data from another 250 trials has been contributed by the other participating companies.

“Greater access to patient level data from clinical trials offers significant opportunities to conduct further research to advance medical science and improve patient care,” a GSK representative told Clinical Informatics News in reference to the company’s recent transparency initiatives. “This ability to replicate, challenge or combine data is key to scientific progress and with large studies the usual scientific method of repeating the experiment is often not an option. Greater access to patient level data therefore helps ensure the data provided by research participants are used to maximum effect in the creation of knowledge and understanding.”

Meanwhile, a separate system for sharing patient-level data from Johnson & Johnson’s clinical trials began considering requests this week, under the management of a review board at Yale University.