The National Drug Abuse Treatment Clinical Trials Network Data Share project: Website design, usage, challenges, and future directions.

There are many benefits of data sharing, including the promotion of new research from effective use of existing data, replication of findings through re-analysis of pooled data files, meta-analysis using individual patient data, and reinforcement of open scientific inquiry. A randomized controlled trial is considered the “gold standard” for establishing treatment effectiveness, but clinical trial research is very costly — sharing data is an opportunity to expand the investment of the clinical trial beyond its original goals at minimal cost. This article describes the goals, developments, and usage of the Data Share website for the National Drug Abuse Treatment Clinical Trials Network (CTN) in the U.S., including lessons learned, limitations, and major revisions, and considerations for future directions to improve data sharing. Since its inception in 2006 and through October 2012, nearly 1700 downloads from 27 clinical trials have been accessed from the Data Share website, with use increasing over the years. Individuals from 31 countries have downloaded data from the site, and there have been at least 13 publications derived from analysis of data obtained through the public Data Share website. Limitations of the website include minimal control over data requests and usage, which has resulted in little information and lack of control regarding how the data from the website are being used, and a lack of uniformity in data elements collected across CTN trials, which has limited cross-study analyses.

Conclusions: The Data Share website offers researchers easy access to de-identified data files with the goal to promote additional research and identify new findings from completed CTN studies. To maximize the utility of the website, ongoing collaborative efforts are needed to standardize the core measures used for data collection in the CTN studies with the goal of increasing their comparability and facilitating the ability to pool data files for cross-study analyses.

Supported by the Duke Clinical Research Institute (CTN DSC 1).