Two reporting requirements, divergent compliance: results-posting rises while PCR-correction stalls in 2,039 registered malaria trials

Abstract

Do malaria trials registered on ClinicalTrials.gov comply with two reporting requirements â the FDAAA results-posting mandate and the WHO PCR-correction declaration in primary outcomes? The AACT 2026-04-12 snapshot of 2,039 registered malaria trials, 2004â2024 by primary completion date, was analyzed. P01 = the fraction posting results within 12 months; P03 = the fraction declaring PCR-correction (strict regex plus ACPR-inclusive broad regex), with Wilson 95% CIs. Compliance was below target: P01 = 5.3% [4.2, 6.6] of 1,407 completed trials; P03 strict = 5.4% [4.3, 6.7] / broad = 9.0% [7.6, 10.7] of 1,302 drug-efficacy trials. Trajectories diverged: FDAAA results-posting rose 2.5% â 10.1% pre/post-2017 (Fisher p<0.001), whereas WHO PCR-correction did not significantly change, 6.8% â 5.1% pre/post-2009 (p=0.43). Malaria-specific FDAAA compliance trails the ~41% cross-disease benchmark ~eightfold; the WHO methodological standard has not moved without enforcement infrastructure. P03 strict is a lower bound; trials registered only in PACTR/CTRI/ISRCTN are outside this corpus.