Preparing individual patient data from clinical trials for sharing: the GlaxoSmithKline approach-Reference-Cited by-同舟云学术

Preparing individual patient data from clinical trials for sharing: the GlaxoSmithKline approach

Published:2014-03-25 Issue:3 Volume:13 Page:179-183
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceut. Statist.

Author:

Hughes Sara¹,Wells Karen²,McSorley Paul³,Freeman Andrew⁴

Affiliation:

1. Clinical Statistics; GSK Research and Development; Stockley Park West Uxbridge Middlesex UB11 1BT UK

2. Statistical Governance; GSK Research and Development; Stockley Park West Uxbridge Middlesex UB11 1BT UK

3. Clinical Statistics; GSK Research and Development; 5 Moore Drive, Research Triangle Park NC 27709 USA

4. Office of the Chief Medical Officer; GSK Research and Development; 980 Great West Road Brentford Middlesex TW8 9GS UK

Funder

GlaxoSmithKline

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference14 articles.

1. European Medicines Agency releases for public consultation its draft policy on the publication and access to clinical-trial data http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/06/news_detail_001825.jsp&mid=WC0b01ac058004d5c1 th

2. Clinical trial data for all drugs in current use;Godlee;British Medical Journal,2012

3. European Federation of Pharmaceutical Industries and Associations & Pharmaceutical Research & Manufacturers of America Principles for responsible data sharing 2013 http://transparency.efpia.eu/uploads/Modules/Documents/data-sharing-prin-final.pdf nd

4. United States Food & Drugs Administration Availability of masked and de-identified non-summary safety and efficacy data: request for comments 2013 https://www.federalregister.gov/articles/2013/06/04/2013-13083/availability-of-masked-and-de-identified-non-summary-safety-and-efficacy-data-request-for-comments nd

5. Access to patient-level data from GlaxoSmithKline clinical trials;Nisen;New England Journal of Medicine,2013

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