ArticleTrials2025
Scientific review of protocols to enhance informativeness of global health clinical trials.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
5 citing papers in PubMed.
- The Governance Gap: Democratizing Drug Development Through Decision Architecture.Clinical pharmacology and therapeutics · 2026Review
- A literature review and reflection on clinical trials: current challenges, future directions, and potential strategies to overcome practical barriers.AME clinical trials review · 2026Article
- Large Language Models for Clinical Trial Protocol Assessments.Clinical pharmacology and therapeutics · 2026Article
- Improving Trial Informativeness: A Rapid Review of Global Research on How to Ensure Trials Are Useful.Journal of evaluation in clinical practice · 2025Review
- A maturity model for the scientific review of clinical trial designs and their informativeness.Trials · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
backgroundTrial informativeness describes the likelihood of a clinical trial to have a meaningful impact on clinical practice, research, or policy decisions. A dedicated scientific review process for protocols at the post-funding stage is not common, yet is an opportunity to enhance trial informativeness. The Bill and Melinda Gates Foundation (BMGF), one of the largest funders of clinical trials, created a group called Design, Analyze, Communicate (DAC). DAC's first completion of an expert scientific review of a grantee's trial protocol was in 2020. We categorized and quantified areas of scientific review feedback provided for 52 clinical trial protocols submitted to DAC over a 3-year period. Most trials planned to study treatment interventions and included at least one trial site in a low- and middle-income country. Feedback themes offer insight into areas of trial design weakness.
methodsWe conducted a retrospective analysis of protocol review feedback provided by DAC to grantees. Reviews were completed by BMGF between 2020 and 2022. A qualitative content analysis was conducted by developing a codebook of clinical trial methodology topics and subtopics and systematically coding free-text review feedback. Manual text classification of individual feedback statements enabled quantification and frequency analysis of review feedback.
resultsA total of 1537 individual recommendations were made across all 52 protocols. The median number of recommendations per protocol was 28 (range: 13 to 52), covering a wide range of issues related to clinical trial design, implementation, analysis, and impact. Nearly half of all recommendations (47%) were characterized by the review team as high priority. The areas with the highest frequency of recommendations were statistics and data analysis, trial procedures, and intervention/dose.
conclusionsThis study provides a taxonomy of scientific review feedback topic areas that can be used to categorize clinical trial design topics. The high number of recommendations per protocol review across several distinct topic areas highlights the need for a scientific review to enhance trial informativeness. This review must take place prior to trial initiation and review teams should include statistical and trial design expertise with additional expertise tailored to the trial/intervention type and phase.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.