Difficulties can arise in organizing, conducting and publishing the results of clinical trials of novel pharmaceuticals since the objectives of investigators, the FDA and industry sponsors are not always identical. Nascent changes in the traditional requirements placed upon investigators by some industry sponsors of antibiotic clinical trials now seek to fundamentally alter traditional policies relating to the presentation and publication of the data arising from such trials. These developments prompt the Council of the Surgical Infection Society to restate the following relevant principles which traditionally have governed clinical investigations.
Investigators have an unlimited right to all data generated by their participation in a clinical trial.
The analysis and presentation of data are the responsibility of investigators and cannot be separated from the body of ethical requirements placed upon and ac cepted by investigators through their participation in a clinical trial.
The context and interpretation of any presentation