Sharing and reuse of individual participant data from clinical trials: principles and recommendations.

ABSTRACT:

Objectives

We examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach.

Design and methods

This was a consensus-building process among the members of a multistakeholder task force, involving a wide range of experts (researchers, patient representatives, methodologists, information technology experts, and representatives from funders, infrastructures and standards development organisations). An independent facilitator supported the process using the nominal group technique. The consensus was reached in a series of three workshops held over 1 year, supported by exchange of documents and teleconferences withi

SUBMITTER: Ohmann C 

PROVIDER: S-EPMC5736032 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature