Proposed best practice for statisticians in the reporting and publication of pharmaceutical industry-sponsored clinical trials.
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.
Matcham
James
J
Amgen Ltd., Global Biostatistics and Epidemiology, Cambridge, UK. jamesm@amgen.com
Julious
Steven
S
Pyke
Stephen
S
O'Kelly
Michael
M
Todd
Susan
S
Seldrup
Jorgen
J
Day
Simon
S
D022126:Access to Information / Q000941:ethics; D002986:Clinical Trials as Topic / Q000191:economics / Q000379:methods*; D016265:Conflict of Interest / Q000191:economics; D004345:Drug Industry / Q000191:economics*; D006801:Humans; D011642:Publications / Q000941:ethics / Q000592:standards*; D011643:Publishing / Q000941:ethics / Q000592:standards*; D012042:Registries; D012109:Research Support as Topic / Q000191:economics / Q000941:ethics; D013223:Statistics as Topic / Q000592:standards*