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

Abstract

Background The 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 as the “gold standard” for establishing treatment effectiveness, but clinical trial research is very costly and sharing data is an opportunity to expand the investment of the clinical trial beyond its original goals at minimal costs. Purpose We describe the goals, developments, and usage of the Data Share website (www.ctndatashare.org) for the National Drug Abuse Treatment Clinical Trials Network (CTN) in the US, including lessons learned, limitations and major revisions and considerations for future directions to improve data sharing. Methods Data management and programming procedures were conducted to produce uniform and Health Insurance Portability and Accountability Act (HIPAA)-compliant de-identified research data files from the completed trials of the CTN for archiving, managing, and sharing on the Data Share website. Results 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 the use increasing over the years. Individuals from 31 countries have downloaded data from the website, and there have been at least 13 publications derived from analyzing data through the public Data Share website. Limitations Minimal control over data requests and usage has resulted in little information and lack of control regarding how the data from the website are used. Lack of uniformity in data elements collected across CTN trials has limited cross-study analyses. Conclusions The Data Share website offers researchers easy access to deidentified data files with the goal to promote additional research and identify new findings from completed CTN studies. To maximize the utility of the website, on-going collaborative efforts are needed to standardize the core measures used for data collection in the CTN studies with the goal to increase their comparability and to facilitate the ability to pool data files for cross-study analyses.

Transparency and objectivity in governance of clinical trials data sharing: Current practices and approaches

“…This is in contrast to an open access model, which allows access to the datasets without any constraints. Since companies and other data holders have interests and responsibilities in managing access to data, adopting an open access model may seem disadvantageous, as “there is little information and a lack of control regarding how the data are used.” 4 In addition, privacy concerns regarding sharing health and genomic data underlines the importance of adopting a level of control when sharing individuals’ data.…”

“…Examples include the Immune Tolerance Network-Trial Share and the National Drug Abuse Treatment Clinical Trials Network Data Share. 4,5 In addition to efforts for data sharing in publicly funded trials, several pharmaceutical companies announced their commitment to data sharing. Moreover, various professional organizations have published statements supporting clinical trials data sharing.…”

Data sharing platforms for de-identified data from human clinical trials

“…We analyze in greater detail one data platform called Data Share of the National Institute on Drug Abuse (NIDA; available at https://datashare.nida.nih.gov). 24 NIDA is the lead federal agency supporting scientific research on drug use. This section will present descriptive information about this data sharing platform that we were able to obtain through affiliation with Data Share.…”

“…The Data Share portal is meant to increase data circulation and use within the larger scientific community, to promote new research as well as secondary analyses and to increase the ultimate scientific contribution of the original research. 24 See Table 3 for the most downloaded studies in Data Share.…”

Core outcomes set for research on the treatment of opioid use disorder (COS-OUD): the National Institute on Drug Abuse Clinical Trials Network protocol for an e-Delphi consensus study

“…Established in 1999, the National Drug Abuse Treatment Clinical Trials Network (CTN) is a network of university- and health system-based research groups and healthcare service providers that collaborate on research on OUD and other substance use disorders, and coordinates data and discovery across a multitude of trials. De-identified research data from these completed trials are distributed to the scientific community and the public at large through an electronic repository, the National Institute on Drug Abuse Data Share website [ 6 , 7 ]. One feature of the website is that it displays the assessments used in each study, by construct-based category, and identifies studies that use similar assessments.…”