Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices.

ABSTRACT:

Objectives

To develop and pilot a tool to measure and improve pharmaceutical companies' clinical trial data sharing policies and practices.

Design

Cross sectional descriptive analysis.

Setting

Large pharmaceutical companies with novel drugs approved by the US Food and Drug Administration in 2015.

Data sources

Data sharing measures were adapted from 10 prominent data sharing guidelines from expert bodies and refined through a multi-stakeholder deliberative process engaging patients, industry, academics, regulators, and others. Data sharing practices and policies were assessed using data from ClinicalTrials.gov, Drugs@FDA, corporate websites, data sharing platforms and registries (eg, the Yale Open Data Access (YODA) Project and Clinical Study Data Request (CSDR)

SUBMITTER: Miller J 

PROVIDER: S-EPMC6614834 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature