Unpublished clinical trials of common rheumatic diseases
Authors' conclusion
Nearly one in five RCTs in rheumatology remain unpublished 2 years after trial completion, and publication is associated with positive primary outcome measures.
Study context
- Population
- Registered randomized controlled trials (RCTs) in five rheumatic diseases (SLE, vasculitis, SpA, SS and PsA) with over 30 months since study completion, ClinicalTrials.gov
- Participants
- 203 RCTs
- Exposure
- Published vs unpublished registered RCTs
- Outcome
- Proportion of unpublished RCTs and factors associated with publication
Methodological detailsregistry-based (ClinicalTrials.gov), survey of corresponding authors, multivariable Cox proportional hazards model
- Registry-based (ClinicalTrials.gov)
- Survey of corresponding authors
- Multivariable Cox proportional hazards model
Main finding
As reported in the abstract
Unpublished RCTs
Unpublished
17.2%
- Trial participants in unpublished RCTs
- 4281
Observational data: associations, not effects.
Further findings
Phase 3 RCTs
P < 0.05
Positive primary outcome measure
P < 0.001
| Outcome | HR (95% CI) | |
|---|---|---|
| Publication, positivevs non-positive outcome (multivariable Cox model) | 1.55 (1.09–2.22) | |
| 0.512Hazard ratio (log scale) |
Reasons for non-publication (corresponding authors of 10 unpublished trials)
- Ongoing preparation of the manuscript
- 50.0%
- Sponsor/funder issues
- 40.0%
- Unimportant/negative result
- 20.0%
Original publication
Unpublished clinical trials of common rheumatic diseases. Rheumatology (Oxford). Published 27 March 2023. doi:10.
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