A perspective piece, published by researchers from Rutgers University, laments the lack of interest shown by researchers in a clinical trial data-sharing project launched in January 2014.
A perspective piece, published by researchers from Rutgers University in the New England Journal of Medicine, laments the lack of interest shown by researchers in a clinical trial data-sharing project launched in January 2014. The website for the project, ClinicalStudyDataRequest.com (CSDR), provides researchers access to raw patient data, which can further improve the understanding of specific studies. However, the project seems to have had a very slow start.
Through CSDR, researchers have the freedom to access de-identified patient data; this initially included data from more than 200 trials conducted since January 2007 and made available by GlaxoSmithKline. Subsequent participants in the project included several other companies, including Astellas, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Eisai, GlaxoSmithKline, Lilly, Novartis, Roche, Sanofi, and Takeda. In January 2014, CSDR began accepting researcher requests for access to this data, which is reviewed by an independent panel, prior to approval. In 2015, the Wellcome Trust then took over the operations of the review panel, and vetoes were restricted to encourage increased data mining.
The authors—who were a part of the original review committee—have provided feedback based on a survey sent to lead investigators whose protocols were approved by the committee, as well as a survey filled out by sponsors about publications that they were aware of.
During a 2-year period between May 7, 2013, and November 14, 2015, the committee reviewed about 177 research proposals, 144 of which were approved. The proposals included requests for data from 237 studies that were not in the CSDR system, and access was granted to 179. A majority of proposals planned to conduct a new study, and the most common diseases being studied were cancer (34), cardiovascular disease (21), asthma and chronic obstructive pulmonary disease (13), and HIV (8).
When asked whether researchers were just not aware of the existence of this data-sharing project, Brian Strom, MD, MPH, chancellor, Rutgers Biomedical and Health Sciences, and lead author on the article, said in an e-mail, "That is possible, but even those who applied and were granted access did not use it enough to result in published papers."
The survey received a lukewarm response, with only 24 investigators participating. Half the respondents (13) indicated that they were still analyzing data at the time of the survey, 3 had completed their analysis, and 8 said their application was still under review, awaiting resubmission, or pending legalities between the applicant institution and the sponsor. Strikingly, only 1 paper has been published out of the proposed projects that were approved during the 2-year period.
The authors indicate that certain inhibitions that the pharmaceutical industry had, regarding reanalysis of their original data or their findings being disproved, were not realized. This could encourage increased participation in CSDR by drug developers in the future.
The authors blame several factors for the poor interest in CSDR, including data analysis behind a firewall, inefficiency of the proposal approval process, and incomplete proposal submission by the investigators. Considering the potential impact of such a data-sharing project on clinical research, the authors emphasize the need to develop better ways to improve use and the output of such projects by clinicians.
According to Strom, while new data from both the pharmaceutical industry and froma cademia can broaden the scope of this project, "it is probably better to find out from users why they did not make use of the old system first."
Strom BL, Buyse ME, Hughes J, and Knoppers BM. Data sharing—is the juice worth the squeeze? N Engl J Med. 2016; 375:1608-1609. doi: 10.1056/NEJMp1610336.