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Clinical Trial Transparency and Orphan Drug Development: Recent Trends in Data Sharing by the Pharmaceutical Industry

So D. · Joly Y. · Knoppers B.M.

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Centre for Genomics and Policy, McGill University, Montreal, Que., Canada

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Public Health Genomics 2013;16:322-335

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Article / Publication Details

First-Page Preview
Abstract of  

Published online: February 03, 2014
Issue release date: February 2014

Number of Print Pages: 14
Number of Figures: 4
Number of Tables: 3

ISSN: 1662-4246 (Print)
eISSN: 1662-8063 (Online)

For additional information: https://www.karger.com/PHG

Abstract

Background: Data sharing from clinical trials can be key to the development and approval of medicines for rare diseases. Many events during the first half of 2013 have contributed to the movement for increased transparency. These include the development of the European Medicines Agency's new data publication policy, the creation of the AllTrials petition and GlaxoSmithKline's choice to sign it, the launch of GlaxoSmithKline's system for access to patient-level clinical trial data and Roche's commitment to create a similar system, the release of results from the Yale University Open Data Access project's first medicine analysis for Medtronic, and the creation of the Reg4All website. Aims/Objectives: This paper summarises major developments in clinical trial transparency between January and June 2013 and analyses the composition of datasets released by GlaxoSmithKline. Methods: GlaxoSmithKline's database of available trials was tabulated and graphs of relevant trial characteristics were produced. Results/Conclusions: Due to current transparency initiatives, it is likely that much more data will be made available over the next few years through systems similar to GlaxoSmithKline's. Although some aspects of GlaxoSmithKline's model could limit its usefulness, the data currently listed is diverse and could be promising for researchers interested in rare disease treatment.

© 2013 S. Karger AG, Basel


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Article / Publication Details

First-Page Preview
Abstract of  

Published online: February 03, 2014
Issue release date: February 2014

Number of Print Pages: 14
Number of Figures: 4
Number of Tables: 3

ISSN: 1662-4246 (Print)
eISSN: 1662-8063 (Online)

For additional information: https://www.karger.com/PHG


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