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

Publication Type
Journal Article
Year of Publication
2018
Authors
Huser, Vojtech; Shmueli-Blumberg, Dikla
Secondary
Clin Trials
Volume
15
Start Page
413
Pagination
413-423
Date Published
08/2018
Keywords
common data elements; data sharing; individual participant data
Abstract

Data sharing of de-identified individual participant data is being adopted by an increasing number of sponsors of human clinical trials. In addition to standardizing data syntax for shared trial data, semantic integration of various data elements is the focus of several initiatives that define research common data elements. This perspective article, in the first part, compares several data sharing platforms for de-identified clinical research data in terms of their size, policies and supported features. In the second part, we use a case study approach to describe in greater detail one data sharing platform (Data Share from National Institute of Drug Abuse). We present data on the past use of the platform, data formats offered, data de-identification approaches and its use of research common data elements. We conclude with a summary of current and expected future trends that facilitate secondary research use of data from completed human clinical trials.