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Proposed best practice for statisticians in the reporting and publication of pharmaceutical industry‐sponsored clinical trials |
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| Authors: | James Matcham Steven Julious Stephen Pyke Michael O'Kelly Susan Todd Jorgen Seldrup Simon Day |
| Affiliation: | 1. Amgen Ltd., Cambridge, UK;2. Medical Statistics Group, ScHARR, University of Sheffield, Sheffield, UK;3. Pfizer Ltd., Sandwich, UK;4. Quintiles Ireland Ltd., Dublin, Ireland;5. Applied Statistics, The University of Reading, Reading, UK;6. Quintiles, Rue Jean‐Dominique Cassini, Illkirch, France;7. Roche Products Limited, Welwyn Garden City, UK |
| 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. Copyright © 2010 John Wiley & Sons, Ltd. |
| Keywords: | trial reports trial protocols publication authorship clinical trial registration |