Observational studyTherapeutic innovation & regulatory science2025
Incidence and Characterization of Important Protocol Deviations in Clinical Trials in Argentina.
Observational study in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Protocol Deviations at an Academic Clinical Research Unit: Insights and Strategies for Prevention.Clinical and translational science · 2026Article
- Analysis of Serious Breach Cases Reported in the EU Clinical Trials Information System: Quantitative and Qualitative Assessment.Therapeutic innovation & regulatory science · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundImportant protocol deviations (PDs) are those that may significantly impact the completeness, accuracy, or reliability of study data, or that may significantly affect a subject’s rights, safety, or well-being. There is limited international evidence about the incidence and characterization of important PDs, with a lack of data specific to Latin America.
methodsThis was a non-interventional, secondary data, observational study based on important PDs reported in phase 2–3 clinical trials. Data were collected from electronic reports submitted between 2014 and 2024 to the Independent Ethics Committee (IEC). The main objective was to assess the incidence and characterize important PDs. A secondary objective was to evaluate possible factors associated with the incidence of important PDs.
resultsA total of 343 clinical trials, involving 7047 randomized participants, were included in the observational period. The overall proportion of patients with important PDs was 9.2% (95% CI: 8.54–9.9%). The primary factor associated with the number of important PDs was the number of randomized patients (Incidence Rate Ratio [IRR]: 1.01; 95% CI: 1–1.02; p < 0.05). A trend was observed for the disease category, with oncology studies tending toward a higher incidence compared to non-oncology studies (IRR: 1.81; 95% CI: 0.92–3.84; p = 0.09).
conclusionsThe overall incidence of important PDs in this study was low, with the highest proportion observed in oncology studies. Important PDs were significantly associated with the number of randomized patients and showed a trend toward association with more complex oncology studies.
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Registered trials
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