Association between trial registration and positive study findings: cross sectional study (Epidemiological Study of Randomized Trials—ESORT)

Ayodele Odutayo · Connor A. Emdin · Allan J. Hsiao · Mubeen Shakir · Bethan J Copsey · Susan Dutton +6 more

51 citations0/0 files storedBMJ

No readable copy stored yet — this record is metadata only.

No open-access location is known for this record yet.

Literature note Cite in a project Citation map

Meta-analysis and systematic reviews Academic Publishing and Open Access Pharmaceutical industry and healthcare

Abstract

Abstract Objective To assess whether randomised controlled trials (RCTs) that were registered were less likely to report positive study findings compared with RCTs that were not registered and whether the association varied by funding source. Design Cross sectional study. Study sample All primary RCTs published in December 2012 and indexed in PubMed by November 2013. Trial registration was determined based on the report of a trial registration number in published RCTs or the identification of the trial in a search of trial registries. Trials were separated into prospectively and retrospectively registered studies. Main outcome measure Association between trial registration and positive study findings. Results 1122 eligible RCTs were identified, of which 593 (52.9%) were registered and 529 (47.1%) were not registered. Overall, registration was marginally associated with positive study findings (adjusted risk ratio 0.87, 95% confidence interval 0.78 to 0.98), even with stratification as prospectively and retrospectively registered trials (0.87, 0.74 to 1.03 and 0.88, 0.78 to 1.00, respectively). The interaction term between overall registration and funding source was marginally statistically significant and relative risk estimates were imprecise (0.75, 0.63 to 0.89 for non-industry funded and 1.03, 0.79 to 1.36 for industry funded, P interaction=0.046). Furthermore, a statistically significant interaction was not maintained in sensitivity analyses. Within each stratum of funding source, relative risk estimates were also imprecise for the association between positive study findings and prospective and retrospective registration. Conclusion Among published RCTs, there was little evidence of a difference in positive study findings between registered and non-registered clinical trials, even with stratification by timing of registration. Relative risk estimates were imprecise in subgroups of non-industry and industry funded trials.

Paper brief

Loading…

Cite this work

Citation unavailable for this work.

BibTeX RIS CSL-JSON

No public copy is stored for this record, so only the metadata is cited.

Citations in this library

Citation map →

Stored only when both papers are in the corpus — 51 citations exist upstream.

References

2010CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials 2012Influence of Reported Study Design Characteristics on Intervention Effect Estimates From Randomized, Controlled Trials 2002Development of a highly sensitive search strategy for the retrieval of reports of controlled trials using PubMed 2009Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials 2005Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors 2004Clinical trial registration: a statement from the International Committee of Medical Journal Editors 2014Reporting of Results in ClinicalTrials.gov and High-Impact Journals 2016Make journals report clinical trials properly

Cited by

2018Evaluating the Completeness of ClinicalTrials.gov 2024A systematic review and meta-analysis of strategies to promote vaccination uptake 2024Improving the transparency and reliability of observational studies through registration 2018Registered trials report less beneficial treatment effects than unregistered ones: a meta-epidemiological study in orthodontics

Explore the map →

Papers that cite the same references — the relational fallback while embeddings are still backfilling.

Imported from OpenAlex (CC0) — nothing here is generated.