Resource implications of preparing individual participant data from a clinical trial to share with external researchers.

ABSTRACT:

Background

Demands are increasingly being made for clinical trialists to actively share individual participant data (IPD) collected from clinical trials using responsible methods that protect the confidentiality and privacy of clinical trial participants. Clinical trialists, particularly those receiving public funding, are often concerned about the additional time and money that data-sharing activities will require, but few published empirical data are available to help inform these decisions. We sought to evaluate the activity and resources required to prepare anonymised IPD from a clinical trial in anticipation of a future data-sharing request.

Methods

Data from two UK publicly funded clinical trials were used for this exercise: 2437 participants with epilepsy recruited fr

SUBMITTER: Tudur Smith C 

PROVIDER: S-EPMC5512949 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature