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dc.contributor.authorSnow, Kristin Ken_US
dc.contributor.authorBell, Margaret Cen_US
dc.contributor.authorStoddard, Anne Men_US
dc.contributor.authorCurto, Teresa Men_US
dc.contributor.authorWright, Elizabeth Cen_US
dc.contributor.authorDienstag, Jules Len_US
dc.date.accessioned2014-07-07T17:04:13Z
dc.date.issued2014en_US
dc.identifier.citationSnow, Kristin K, Margaret C Bell, Anne M Stoddard, Teresa M Curto, Elizabeth C Wright, and Jules L Dienstag. 2014. “Processes to manage analyses and publications in a phase III multicenter randomized clinical trial.” Trials 15 (1): 159. doi:10.1186/1745-6215-15-159. http://dx.doi.org/10.1186/1745-6215-15-159.en
dc.identifier.issn1745-6215en
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:12406792
dc.description.abstractBackground: 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).en
dc.language.isoen_USen
dc.publisherBioMed Centralen
dc.relation.isversionofdoi:10.1186/1745-6215-15-159en
dc.relation.hasversionhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC4040510/pdf/en
dash.licenseLAAen_US
dc.subjectPublication guidelinesen
dc.subjectPublication processesen
dc.subjectPublication managementen
dc.subjectHALT-C trialen
dc.subjectAuthorship assignmenten
dc.subjectAuthorship allocationen
dc.titleProcesses to manage analyses and publications in a phase III multicenter randomized clinical trialen
dc.typeJournal Articleen_US
dc.description.versionVersion of Recorden
dc.relation.journalTrialsen
dash.depositing.authorDienstag, Jules Len_US
dc.date.available2014-07-07T17:04:13Z
dc.identifier.doi10.1186/1745-6215-15-159*
dash.contributor.affiliatedDienstag, Jules


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