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

Kristin K Snow, Margaret C Bell, Anne M Stoddard, Teresa M Curto, Elizabeth C Wright, Jules L Dienstag, Kristin K Snow, Margaret C Bell, Anne M Stoddard, Teresa M Curto, Elizabeth C Wright, Jules L Dienstag

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).

Figures

Figure 1
Figure 1
HALT-C manuscript timelines. This figure includes publications that were tracked starting in July of study year 9. Thirty-three publications, classified as study-wide, local, or secondary, were analyzed at the DCC and ten publications were analyzed at other institutions using a DUA. The color codes indicate the activity stage. DCC, data coordinating center; DUA, data use agreement.
Figure 2
Figure 2
Number of HALT-C publications and abstracts by year published. A: The light grey portions are for the 36 publications that used only baseline or lead-in phase data and the dark grey portions are for the 38 publications using data from the randomized phase of the HALT-C trial. B: The light grey portions are for the 33 abstracts that used only baseline or lead-in phase data and the dark grey portions are for the 22 abstracts using data from the randomized phase of the HALT-C trial. Study year represents the number of years from the start of the study.
Figure 3
Figure 3
Cumulative distribution of time from start of analysis to journal acceptance. These 33 HALT-C publications, closely tracked by the publications committee, had a median time from start of analysis to acceptance of 18 months (range 5 to 57).

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Source: PubMed

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