Cardio-oncology & otherMeta-analysis
Extension Reports in Clinical Trials
- Systematic review (methodological survey) of cardiovascular trial extension reports
- 2 reviewers
- standard proforma
Authors' conclusion
This first systematic investigation into the reporting of extension studies found a great diversity in practice, noting several issues that need more adequate consideration.
Study context
- Population
- Extension reports of CV trials published Jan 2019–Oct 2023 in 7 high-impact medical journals
- Participants
- 69 participants · 64 trials
Pooled result
As reported in the abstract
Characteristics of extension reports of CV trials
- Extension reports identified (of 1,388 papers screened), across 64 trials
- 69
- CHD topic (most common)
- 20
- Original 1-year report with extension at 2, 3, 5 or 10 years (most common)
- 20
- Superiority hypothesis
- 68
- Same primary outcome as original publication
- 53
- Nonrandomized open-label extensions (no concurrent control arm)
- 7
- Treatment crossovers permitted during extension
- 18
- Alternatives to ITT analysis used
- 16
- Prespecified extension studies
- 38
- Dedicated protocols or statistical analysis plans
- 10
- Landmark analyses (not based on original randomized groups)
- 39
- Loss to follow-up >10% (of 50 reports with clear reporting)
- 10
Original publication
Extension Reports in Clinical Trials. J Am Coll Cardiol. Published 11 February 2026. doi:10.1016/j.jacc.2025.12.012
Summarised from the published abstract; every number is checked against it