Evidence map›Paper›PMID 24886378›Full record

Trial reportTrials2014

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

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00006164 (Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00006164 phase3completednot on this map

Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial (HALT-C)

TypeinterventionalSponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Ran2000 to 2009Enrolled1,050ConditionsChronic Hepatitis c, Cirrhosis, Liver, Fibrosis, Liver, Hepatic CirrhosisArmsPeginterferon alfa-2a + Ribavirin, Peginterferon alfa-2a
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Kristin K Snow
Margaret C Bell
Anne M Stoddard
Teresa M CurtoNew England Research Institutes, 9 Galen Street, Watertown, MA 02472, USA. tcurto@neriscience.com.
Elizabeth C Wright
Jules L Dienstag

Funding

HEPATITIS C CLINICAL TRIAL-DATA COORDINATING CENTER-267092328N01DK092328 · NIDDK · NEW ENGLAND RESEARCH INSTITUTES, INC. · 1999 to 2004
$1.5M
HEPATITIS C CLINICAL TRIAL-CLINICAL CENTERSN01DK092326 · NIDDK · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI BONKOVSKY, HERBERT L · 1999 to 2000
$872k
HEPATITIS C CLINICAL TRIAL- CLINICAL CENTERSN01DK092322 · NIDDK · VIRGINIA COMMONWEALTH UNIVERSITY · PI SHIFFMAN, MITCHELL L · 1999 to 2000
$699k
HEPATITIS C CLINICAL TRIAL-CLINICAL CENTERSN01DK092325 · NIDDK · UNIVERSITY OF SOUTHERN CALIFORNIA · PI LINDSAY, KAREN L · 1999 to 2000
$697k
HEPATITIS C CLINICAL TRIALS- CLINICAL CENTERSN01DK092320 · NIDDK · UNIVERSITY OF CALIFORNIA IRVINE · PI HOEFS, JOHN C · 1999 to 2000
$627k
HEPATITIS C CLINICAL TRIAL-CLINICAL CENTERSN01DK092324 · NIDDK · SAINT LOUIS UNIVERSITY · PI BISCEGLIE, ADRIAN · 1999 to 2000
$568k
HEPATITIS C CLINICAL TRIAL-CLINICAL CENTERSN01DK092327 · NIDDK · UNIVERSITY OF COLORADO DENVER · PI EVERSON, GREGORY THOMAS · 1999 to 2000
$512k
HEPATITIS C CLINICAL TRIAL- VIROLOGY LABORATORYN01DK092318 · NIDDK · UNIVERSITY OF WASHINGTON · PI GREYCH, DAVID · 1999 to 2000
$317k
HEPATITIS C CLINICAL TRIAL-CLINICAL CENTERSN01DK092323 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI LOK, ANNA SF · 1999 to 2000
$233k
HEPATITIS C CLINICAL TRIAL-CLINICAL CENTERSN01DK092319 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI DIENSTAG, JULES LEONARD · 1999 to 2000
$211k
HEPATITIS C CLINICAL TRIAL- CLINICAL CENTERSN01DK092321 · NIDDK · UNIVERSITY OF TEXAS SW MED CTR/DALLAS · PI LEE, WILLIAM M · 1999 to 2000
$109k
NIDDK NIH HHS N01-DK-9-2318NIDDK NIH HHS N01-DK-9-2319NIDDK NIH HHS N01-DK-9-2320NIDDK NIH HHS N01-DK-9-2321NIDDK NIH HHS N01-DK-9-2322NIDDK NIH HHS N01-DK-9-2323NIDDK NIH HHS N01-DK-9-2324NIDDK NIH HHS N01-DK-9-2325NIDDK NIH HHS N01-DK-9-2326NIDDK NIH HHS N01-DK-9-2327NIDDK NIH HHS N01-DK-9-2328
6 · The paper itself

Abstract

backgroundThe 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.

methodsThe 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.

resultsA 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.

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

Indexed as

Data Interpretation, StatisticalManuscripts, Medical as TopicAntiviral AgentsClinical Trials Data Monitoring CommitteesDrug Therapy, CombinationGuideline AdherenceGuidelines as TopicHepatitis CHumansInformation DisseminationInterferon-alphaPeer Review, ResearchPeriodicals as TopicPolyethylene GlycolsRecombinant ProteinsResearch DesignAntiviral AgentsInterferon-alphapeginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsRibavirin

Identifiers

PMID24886378
PMCPMC4040510

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.