Acute stroke: trial by jury. The toothless tiger (role of the principal investigator).
All trials require a principal investigator to take the lead role and act as main contact amongst the various groups of participants. His role ranges from assistance in protocol design; through selection of investigators, monitoring of study conduct and responding to Safety Committee recommendations; to involvement in study reporting and in maintaining access to the data set after the conclusion of the trial. This article describes the role of the principal investigator and Steering Committee in more detail and discusses the issues that arise out of the organisational requirements of modern clinical trials and the potential tensions between the various participating groups.
Lees
Kennedy R
KR
University Department of Medicine and Therapeutics, Gardiner Institute, Western Infirmary, Glasgow G11 6NT, Scotland, UK. k.r.lees@clinmed.gla.ac.uk
Orgogozo
Jean-Marc
JM
D000208:Acute Disease; D026661:Clinical Trials Data Monitoring Committees / Q000941:ethics; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards*; D028741:Ethics Committees, Clinical; D006801:Humans; D020521:Stroke / Q000188:drug therapy*; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use*
D010959:Tissue Plasminogen Activator