Positive Outcomes Influence the Rate and Time to Publication, but Not the Impact Factor of Publications of Clinical Trial Results
TLDR
Clinical trials with positive outcomes have significantly higher rates and shorter times to publication than those with negative results, however, no differences have been found in terms of impact factor.Abstract:
Objectives
Publication bias may affect the validity of evidence based medical decisions. The aim of this study is to assess whether research outcomes affect the dissemination of clinical trial findings, in terms of rate, time to publication, and impact factor of journal publications.
Methods and Findings
All drug-evaluating clinical trials submitted to and approved by a general hospital ethics committee between 1997 and 2004 were prospectively followed to analyze their fate and publication. Published articles were identified by searching Pubmed and other electronic databases. Clinical study final reports submitted to the ethics committee, final reports synopses available online and meeting abstracts were also considered as sources of study results. Study outcomes were classified as positive (when statistical significance favoring experimental drug was achieved), negative (when no statistical significance was achieved or it favored control drug) and descriptive (for non-controlled studies). Time to publication was defined as time from study closure to publication. A survival analysis was performed using a Cox regression model to analyze time to publication. Journal impact factors of identified publications were recorded. Publication rate was 48·4% (380/785). Study results were identified for 68·9% of all completed clinical trials (541/785). Publication rate was 84·9% (180/212) for studies with results classified as positive and 68·9% (128/186) for studies with results classified as negative (p<0·001). Median time to publication was 2·09 years (IC95 1·61–2·56) for studies with results classified as positive and 3·21 years (IC95 2·69–3·70) for studies with results classified as negative (hazard ratio 1·99 (IC95 1·55–2·55). No differences were found in publication impact factor between positive (median 6·308, interquartile range: 3·141–28·409) and negative result studies (median 8·266, interquartile range: 4·135–17·157).
Conclusions
Clinical trials with positive outcomes have significantly higher rates and shorter times to publication than those with negative results. However, no differences have been found in terms of impact factor.read more
Citations
More filters
Journal ArticleDOI
Repeated Structural Imaging Reveals Nonlinear Progression of Experience-Dependent Volume Changes in Human Motor Cortex.
Elisabeth Wenger,Simone Kühn,Julius Verrel,Johan Mårtensson,Nils Bodammer,Ulman Lindenberger,Martin Lövdén,Martin Lövdén +7 more
TL;DR: Time‐series analyses revealed that gray matter in the primary motor cortices expanded during the first 4 weeks and then partially renormalized, in particular in the right hemisphere, despite continued practice and increasing task proficiency, and may qualify as a general principle of structural plasticity.
Journal ArticleDOI
Synovial tissue signatures enhance clinical classification and prognostic/treatment response algorithms in early inflammatory arthritis and predict requirement for subsequent biological therapy: results from the pathobiology of early arthritis cohort (PEAC)
Gloria Lliso-Ribera,Frances Humby,Myles Lewis,Alessandra Nerviani,Daniele Mauro,Felice Rivellese,Stephen Kelly,Rebecca Hands,F Bene,Nandhini Ramamoorthi,Jason A. Hackney,Alberto Cauli,Ernest Choy,Andrew Filer,Peter C. Taylor,Iain B. McInnes,Michael J. Townsend,Costantino Pitzalis +17 more
TL;DR: The capacity to refine early clinical classification criteria through synovial pathobiological markers offers the potential to predict disease outcome and stratify therapeutic intervention to patients most in need.
Journal ArticleDOI
Molecular mechanism of ligand recognition by membrane transport protein, Mhp1
Katie J. Simmons,Scott M. Jackson,Florian Brueckner,Florian Brueckner,Simon G. Patching,Oliver Beckstein,Oliver Beckstein,Ekaterina Ivanova,Tian Geng,Tian Geng,Simone Weyand,Simone Weyand,David A. Drew,Joseph Lanigan,David Sharples,Mark S.P. Sansom,So Iwata,So Iwata,Colin W. G. Fishwick,A. Peter Johnson,Alexander D. Cameron,Alexander D. Cameron,Peter J. F. Henderson +22 more
TL;DR: The molecular events that underlie acquisition and transport of a ligand by Mhp1 are deduced, through a combination of crystallography, molecular dynamics, site‐directed mutagenesis, biochemical/biophysical assays, and the design and synthesis of novel ligands.
Journal ArticleDOI
Disease-modifying treatments and cognition in relapsing-remitting multiple sclerosis: A meta-analysis.
Nils C. Landmeyer,Paul-Christian Bürkner,H. Wiendl,Tobias Ruck,Hans-Peter Hartung,Heinz Holling,Sven G. Meuth,Andreas Johnen +7 more
TL;DR: DMTs are effective in improving cognitive test performance in RRMS, but a treatment escalation mainly to amend cognition is not supported by the current evidence.
Posted ContentDOI
Functional Interpretation of Single-Cell Similarity Maps
TL;DR: The utility of VISION is demonstrated using a relatively homogeneous set of B cells from a cohort of lupus patients and healthy controls and it is shown that it can derive important sources of cellular variation and link them to clinical phenotypes in a stratification free manner.
References
More filters
Journal ArticleDOI
Pharmacological interventions for somatoform disorders in adults.
Maria Kleinstäuber,Michael Witthöft,Andrés Steffanowski,Harm W.J. van Marwijk,Wolfgang Hiller,Michael J. Lambert +5 more
TL;DR: A systematic review and meta-analysis of placebo-controlled studies examined the efficacy and tolerability of different types of antidepressants, the combination of an antidepressant and an antipsychotic, antipsychotics alone, or natural products in adults with somatoform disorders in adults to improve optimal treatment decisions.
Journal ArticleDOI
Improving the quality of reporting of randomized controlled trials. The CONSORT statement.
Colin B. Begg,Mildred K. Cho,Susan Eastwood,Richard Horton,David Moher,Ingram Olkin,Roy M. Pitkin,Drummond Rennie,Kenneth F. Schulz,David L. Simel,Donna F. Stroup +10 more
TL;DR: For RCTs to ultimately benefit patients, the published report should be of the highest possible standard and should provide the reader with the ability to make informed judgments regarding the internal and external validity of the trial.
Journal ArticleDOI
Publication bias in clinical research
TL;DR: The presence of publication bias in a cohort of clinical research studies is confirmed and it is suggested that conclusions based only on a review of published data should be interpreted cautiously, especially for observational studies.
Journal ArticleDOI
Improving the quality of reporting of randomized controlled trials. The CONSORT statement
Colin B. Begg,Mildred K. Cho,Susan Eastwood,Richard Horton,David Moher,Ingram Olkin,Roy M. Pitkin,Drummond Rennie,Kenneth F. Schulz,David L. Simel,Donna F. Stroup +10 more
TL;DR: For RCTs to ultimately benefit patients, the published report should be of the highest possible standard and accurate and complete reporting is needed.
Journal ArticleDOI
Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.
TL;DR: The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols and Published articles, as well as reviews that incorporate them, may therefore be unreliable and overestimate the benefits of an intervention.