Exhibit 095 · Cohort study
Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study
4209 trials were due to report results; 1722 (40·9%; 95% CI 39·4-42·2) did so within the 1-year deadline.
Of 4,209 trials due to report results under the FDA Amendments Act Final Rule, 1,722 (40.9%) had submitted results on time by the 16 September 2019 cutoff, and 2,686 (63.8%) had submitted by that date, counting submissions under quality review. Trials not yet due, outside the rule, or granted a delay were excluded. Industry sponsors had higher adjusted odds of compliance than non-industry, non-US-government sponsors (OR 3.08, 95% CI 2.52–3.77).
- Source
- DeVito et al., The Lancet
- Date
- 2020
- Quoted from
- Abstract, Findings (PubMed PMID 31958402; Lancet 2020;395:361-369)
- Grade
- Peer-reviewed
- Document
- https://doi.org/10.1016/S0140-6736(19)33220-9
- Accessed
- 2026-11-09
- Cited by
- Findings citing this exhibit
- Note
- Author-institution abstract: https://www.bennett.ox.ac.uk/papers/172/.