Mindy Schuster, MD; Helene Panzer, PhD; John Edwards, MD
Potential Financial Conflicts of Interest:Employment: H. Panzer (Pfizer). Grants received: M. Schuster (Pfizer, Astellas, Merck). Consultancies: J. Edwards (Merck, Pfizer, Cerexa, Eisai, Enzon).
Schuster M., Panzer H., Edwards J.; Empirical Use of Fluconazole in Critically Ill Patients: Good Study, but What Was the Hold-up?. Ann Intern Med. 2009;150:59-60. doi: 10.7326/0003-4819-150-1-200901060-00018
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Published: Ann Intern Med. 2009;150(1):59-60.
We appreciate the readers' interest in our study. Dr. Shelburne and Dr. Lee bring up the very important issue of publication delay. Some of the delays that occurred in the reporting of this trial—and in other, similarly complex, multicentered clinical trials conducted in critically ill patient populations—are invariably due to the difficulties in completing the data set after the final patient is enrolled. Performance of quality assurance, data cleaning, site answers to data queries, and review of each individual case by a busy data review committee can be cumbersome and time-intensive processes, which clearly took too long in our study. A study such as ours is a joint venture between the investigators and the sponsor. Although there was an element of initial disappointment with a trial yielding negative results and although the focus of many involved may have been diverted at times during the long process, there was no intentional delay in the publication of these results. Efforts to improve the speed of publication and promote the publication of important clinical trials with negative findings are critical to the dissemination of data that may affect clinical practice. Policies that may speed the publication of clinical trial results include the assignment of dedicated clinical monitors to each study site and the formation of a publication committee and timeline at the onset of the project. In September 2004, an editorial published by the International Committee of Medical Journal Editors (1) stated that, beginning in September 2005, clinical trials could only be considered for publication if they had been publicly registered before patient enrollment. This policy will help promote the reporting of all clinical trials.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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