Systemic sclerosis & Raynaud's
Trial-level factors affecting accrual rate of systemic sclerosis randomized clinical trials
Authors' conclusion
Recruiting SSc patients for RCTs has been challenging, with generally slow accrual over the past 20 years and no significant improvement over time.
Study context
- Population
- Published systemic sclerosis (SSc) randomized controlled trials (RCTs) indexed in PubMed 2000–2024, recruitment completed before the COVID-19 pandemic
- Participants
- 80 RCTs
- Outcome
- Enrollment duration and accrual rate (participants per month)
Methodological detailsmeta-research, multivariable negative binomial generalized linear model
- Meta-research
- Multivariable negative binomial generalized linear model
Pooled result
As reported in the abstract
Median recruitment time, months (IQR 9.9 - 30.0)
15
Median accrual rate, participants per month (IQR 1.6 - 5.5)
3.1
Further pooled results
Factors associated with accrual rate (multivariable analysis)
- Accrual rate positively associated with skewed randomization, blinding, non-industry funding, international recruitment, and inclusion of both SSc subsets, especially vs studies involving only dcSSc patients
Accrual over time
- Faster accrual early in the 2000s and after 2012, slower period in between
Trial characteristics
- Single-country
- 75.0 %
- Industry-funded
- 57.5 %
- Recruiting in Europe
- 36.2 %
- Recruiting in North America
- 22.5 %
- Both limited and diffuse SSc enrolled
- 65 %
- Median sample size, patients
- 40.5
- RCTs enrolling ≥100 patients
- 20 %
Original publication
Trial-level factors affecting accrual rate of systemic sclerosis randomized clinical trials. Semin Arthritis Rheum. Published 3 May 2025. doi:10.
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