Extent of and Reasons for Discontinuation and Nonpublication of Interventional Trials on Connective Tissue Diseases: An Observational Study
Authors' conclusion
One of 3 registered RCTs on CTDs fails to be completed or published.
Study context
- Population
- Interventional randomized controlled trials (RCTs) on connective tissue diseases registered in ClinicalTrials.gov since 2000
- Participants
- 175 studies
- Exposure
- Completed vs Discontinued
- Discontinuedn = 58reference
- Outcome
- Proportion of, reasons for, and factors associated with discontinuation or nonpublication of RCTs on CTDs
Methodological detailscross-sectional analysis of registered RCTs, ClinicalTrials.gov registry search, multivariable logistic regression
- Cross-sectional analysis of registered RCTs
- ClinicalTrials.gov registry search
- Multivariable logistic regression
Main finding
As reported in the abstract
- Discontinued trials, mainly for insufficient patient accrual
- 58 (33%)
- Discontinuation rates across connective tissue diseases (CTDs)
- P > 0.5
- Unpublished among 130 studies with ≥1 patient included
- 46 (35%)
- Published in peer-reviewed journal
- 86 (65%)
- Time from completion to publication, median (IQR)
- 24 months (15-41)
Observational data: associations, not effects.
Further findings
Publication rate, completed vs discontinued studies
P < 0.001
Factors associated with noncompletion and nonpublication
- Small sample size (<100 participants) was the only associated factor
- Reasons for nonpublication obtained in one-third of cases
Original publication
Extent of and Reasons for Discontinuation and Nonpublication of Interventional Trials on Connective Tissue Diseases: An Observational Study. Arthritis Care Res (Hoboken). Published 13 November 2022. doi:10.
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