ArticlePloS one2011
Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy.
Article in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 9 of them syntheses that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
52 citing papers in PubMed, 9 syntheses or guidelines pooled it, 119 citations in OpenAlex.
- Estimating the prevalence of discrepancies between study registrations and publications: a systematic review and meta-analyses.BMJ open · 2023Pooled it
- Endorsement of reporting guidelines and study registration by endocrine and internal medicine journals: meta-epidemiological study.BMJ open · 2019Pooled it
- An empirical assessment of research practices across 163 clinical trials of tumor-bearing companion dogs.Scientific reports · 2019Pooled it
- Outcome reporting bias in randomized-controlled trials investigating antipsychotic drugs.Translational psychiatry · 2017Pooled it
- A systematic review of the processes used to link clinical trial registrations to their published results.Systematic reviews · 2017Pooled it
- Comparison of registered and published outcomes in randomized controlled trials: a systematic review.BMC medicine · 2015Pooled it
- Inadequate use and regulation of interventions against publication bias decreases their effectiveness: a systematic review.Journal of clinical epidemiology · 2015Pooled it
- Neuraminidase inhibitors for preventing and treating influenza in adults and children.The Cochrane database of systematic reviews · 2014Pooled it
- Systematic review of the empirical evidence of study publication bias and outcome reporting bias - an updated review.PloS one · 2013Pooled it
- Development and Evaluation of a Human-in-the-Loop Data Curation Training Program to Support a Digital Clinical Trial Platform: Descriptive Feasibility Study.JMIR formative research · 2026Article
- Risk of Editorial Bias: A Case Study of Factors Contributing to Review Time in a Leading Journal in Dentistry.Clinical and experimental dental research · 2025Article
- Article
- Frequency of multiple changes to prespecified primary outcomes of clinical trials completed between 2009 and 2017 in German university medical centers: A meta-research study.PLoS medicine · 2023Article
- Rotavirus vaccine clinical trials: a cross-sectional analysis of clinical trials registries.Trials · 2022Article
- Outcome reporting bias in nephrology randomized clinical trials: Examining outcomes represented by graphical illustrations.Contemporary clinical trials communications · 2022Article
- Article
- Discrepancies between FDA documents and ClinicalTrials.gov for Orphan Drug-related clinical trial data.PLOS global public health · 2022Article
- Transparency of clinical trials in pancreatic cancer: An analysis of availability of trial results from the ClinicalTrials.gov database.Frontiers in oncology · 2022Article
- Agreement of primary outcomes in chiropractic-related clinical trials registered in clinicaltrials.gov with corresponding publication.The Journal of the Canadian Chiropractic Association · 2021Article
- Prospective registration and reporting of trial number in randomised clinical trials: global cross sectional study of the adoption of ICMJE and Declaration of Helsinki recommendations.BMJ (Clinical research ed.) · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveWe assessed the adequacy of randomized controlled trial (RCT) registration, changes to registration data and reporting completeness for articles in ICMJE journals during 2.5 years after registration requirement policy.
methodsFor a set of 149 reports of 152 RCTs with ClinicalTrials.gov registration number, published from September 2005 to April 2008, we evaluated the completeness of 9 items from WHO 20-item Minimum Data Set relevant for assessing trial quality. We also assessed changes to the registration elements at the Archive site of ClinicalTrials.gov and compared published and registry data.
resultsRCTs were mostly registered before 13 September 2005 deadline (n = 101, 66.4%); 118 (77.6%) started recruitment before and 31 (20.4%) after registration. At the time of registration, 152 RCTs had a total of 224 missing registry fields, most commonly 'Key secondary outcomes' (44.1% RCTs) and 'Primary outcome' (38.8%). More RCTs with post-registration recruitment had missing Minimum Data Set items than RCTs with pre-registration recruitment: 57/118 (48.3%) vs. 24/31 (77.4%) (χ(2) (1) = 7.255, P = 0.007). Major changes in the data entries were found for 31 (25.2%) RCTs. The number of RCTs with differences between registered and published data ranged from 21 (13.8%) for Study type to 118 (77.6%) for Target sample size.
conclusionsICMJE journals published RCTs with proper registration but the registration data were often not adequate, underwent substantial changes in the registry over time and differed in registered and published data. Editors need to establish quality control procedures in the journals so that they continue to contribute to the increased transparency of clinical trials.
Indexed as
Identifiers
What OpenQuestion holds
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.