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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 by Jennifer Miller; Joseph S Ross; Marc Wilenzick; Michelle M Mello is a Health Professions article available to read on EtoBox.

What is 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 about?

## 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)), and personal communication with drug companies. ## Main outcome measures Company level, multicomponent measure of accessibility of participant level clinical trial data (eg, analysis ready dataset and metadata); drug and trial level measures of registration, results reporting, and publication; company level overall transparency rankings; and feasibility of the measures and ranking tool to improve co

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Author

Jennifer Miller; Joseph S Ross; Marc Wilenzick; Michelle M Mello

Publisher

BMJ

Published

2019

Language

EN

Field

Health Professions (Health Sciences)