Regulatory Frameworks for Clinical Trial Data Sharing: Scoping Review.

ABSTRACT:

Background

Although well recognized for its scientific value, data sharing from clinical trials remains limited. Steps toward harmonization and standardization are increasing in various pockets of the global scientific community. This issue has gained salience during the COVID-19 pandemic. Even for agencies willing to share data, data exclusivity practices complicate matters; strict regulations by funders affect this even further. Finally, many low- and middle-income countries (LMICs) have weaker institutional mechanisms. This complex of factors hampers research and rapid response during public health emergencies. This drew our attention to the need for a review of the regulatory landscape governing clinical trial data sharing.

Objective

This review seeks to identify regulat

SUBMITTER: Gudi N 

PROVIDER: S-EPMC9118011 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature