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Pharm Stat. 2011 Jan-Feb;10(1):70-3. doi: 10.1002/pst.417.

Proposed best practice for statisticians in the reporting and publication of pharmaceutical industry-sponsored clinical trials.

Author information

1
Amgen Ltd., Global Biostatistics and Epidemiology, Cambridge, UK. jamesm@amgen.com

Abstract

In this paper we set out what we consider to be a set of best practices for statisticians in the reporting of pharmaceutical industry-sponsored clinical trials. We make eight recommendations covering: author responsibilities and recognition; publication timing; conflicts of interest; freedom to act; full author access to data; trial registration and independent review. These recommendations are made in the context of the prominent role played by statisticians in the design, conduct, analysis and reporting of pharmaceutical sponsored trials and the perception of the reporting of these trials in the wider community.

PMID:
20187020
DOI:
10.1002/pst.417
[Indexed for MEDLINE]

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