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Open Access Research

Processes to manage analyses and publications in a phase III multicenter randomized clinical trial

Kristin K Snow12, Margaret C Bell1, Anne M Stoddard1, Teresa M Curto1*, Elizabeth C Wright3 and Jules L Dienstag45

Author Affiliations

1 New England Research Institutes, 9 Galen Street, Watertown, MA 02472, USA

2 Division of Public Health Services, New Hampshire Department of Health and Human Services, Bureau of Public Health Statistics and Informatics, 129 Pleasant Street, Concord, NH 03301, USA

3 Office of the Director, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Bethesda, MD 20892, USA

4 Gastrointestinal Unit, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA

5 Department of Medicine, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA

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Trials 2014, 15:159  doi:10.1186/1745-6215-15-159

Published: 7 May 2014

Abstract

Background

The timely publication of findings in peer-reviewed journals is a primary goal of clinical research. In clinical trials, the processes leading to publication can be complex from choice and prioritization of analytic topics through to journal submission and revisions. As little literature exists on the publication process for multicenter trials, we describe the development, implementation, and effectiveness of such a process in a multicenter trial.

Methods

The Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) trial included a data coordinating center (DCC) and clinical centers that recruited and followed more than 1,000 patients. Publication guidelines were approved by the steering committee, and the publications committee monitored the publication process from selection of topics to publication.

Results

A total of 73 manuscripts were published in 23 peer-reviewed journals. When manuscripts were closely tracked, the median time for analyses and drafting of manuscripts was 8 months. The median time for data analyses was 5 months and the median time for manuscript drafting was 3 months. The median time for publications committee review, submission, and journal acceptance was 7 months, and the median time from analytic start to journal acceptance was 18 months.

Conclusions

Effective publication guidelines must be comprehensive, implemented early in a trial, and require active management by study investigators. Successful collaboration, such as in the HALT-C trial, can serve as a model for others involved in multidisciplinary and multicenter research programs.

Trial registration

The HALT-C Trial was registered with clinicaltrials.gov (NCT00006164).

Keywords:
Publication guidelines; Publication processes; Publication management; HALT-C trial; Authorship assignment; Authorship allocation