Matcham James, Julious Steven, Pyke Stephen, O'Kelly Michael, Todd Susan, Seldrup Jorgen, Day Simon
Amgen Ltd., Global Biostatistics and Epidemiology, Cambridge, UK.
Pharm Stat. 2011 Jan-Feb;10(1):70-3. doi: 10.1002/pst.417.
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.
在本文中，我们阐述了我们认为制药行业资助的临床试验报告中统计学家应遵循的一系列最佳实践。我们提出了八项建议，涵盖：作者职责与认可；发表时机；利益冲突；行动自由；作者全面获取数据；试验注册与独立审查。这些建议是在统计学家在制药行业资助试验的设计、实施、分析和报告中所发挥的突出作用以及更广泛社区对这些试验报告的认知背景下提出的。
