title: Processes to manage analyses and publications in a phase III multicenter randomized clinical trial.
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.
  
  
  BACKGROUND
  The HALT-C Trial was registered with clinicaltrials.gov (NCT00006164).
authors.forename: Kristin K
authors.initials: KK
authors.lastname: Snow
authors.forename: Margaret C
authors.initials: MC
authors.lastname: Bell
authors.forename: Anne M
authors.initials: AM
authors.lastname: Stoddard
authors.affiliation: New England Research Institutes, 9 Galen Street, Watertown, MA 02472, USA. tcurto@neriscience.com.
authors.forename: Teresa M
authors.initials: TM
authors.lastname: Curto
authors.forename: Elizabeth C
authors.initials: EC
authors.lastname: Wright
authors.forename: Jules L
authors.initials: JL
authors.lastname: Dienstag
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use; D026661:Clinical Trials Data Monitoring Committees / Q000592:standards*; D003627:Data Interpretation, Statistical; D004359:Drug Therapy, Combination; D019983:Guideline Adherence / Q000592:standards*; D017408:Guidelines as Topic / Q000592:standards*; D006526:Hepatitis C / Q000175:diagnosis / Q000188:drug therapy; D006801:Humans; D033181:Information Dissemination; D016898:Interferon-alpha / Q000627:therapeutic use; D008374:Manuscripts, Medical as Topic; D017712:Peer Review, Research / Q000592:standards; D010506:Periodicals as Topic / Q000592:standards*; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000627:therapeutic use; D012107:Research Design / Q000592:standards* / Q000706:statistics & numerical data; D012254:Ribavirin / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a