The scribe of stroke trials.
The responsibility for reports about drug trials in medical journals should lie with the clinicians in the steering committee, not with the industrial sponsor. Examples of undue influence of sponsors on the conduct and analysis are the choice of surrogate outcome events, changes in the protocol during the trial, discontinuation of the study, post hoc analyses and suppression of publication. Since this essay was written, the International Committee of Medical Journal Editors ("Vancouver Group") has issued the condition that authors of submitted manuscripts should guarantee their independence in data analysis and reporting. Nevertheless, this "security check" occurs at a late stage and may not apply to journals that are less well known. Institutional Review Boards should routinely take the matter of independence into account. Also, European guidelines should be rewritten to reflect these fundamental issues rather than a multitude of details. In fact not sponsors or physicians but patients and the general public are the true owners of trial data.
van Gijn
J
J
Department of Neurology, Room G03.228, University Medical Centre, Heidelberglaan 100, NL-3584 CX Utrecht, The Netherlands. J.vanGijn@neuro.azn.nl
D026661:Clinical Trials Data Monitoring Committees / Q000941:ethics; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards*; D028741:Ethics Committees, Clinical; D026690:Ethics, Clinical; D005060:Europe; D006801:Humans