ArticleMethodsX2025
Development of the clinical trial site performance metrics instrument: A study protocol.
Article in MethodsX, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 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
4 citing papers in PubMed.
- Validation of the Ontario Protocol Assessment Level (OPAL) Tool for Assessing Clinical Trial Complexity and Supporting Workforce Planning in the Italian Clinical Research Context.Therapeutic innovation & regulatory science · 2026Article
- Establishing a Clinical Trial Quality Team in a Comprehensive Cancer Center: A Strategy to Navigate the New European Regulatory Landscape.Current oncology (Toronto, Ont.) · 2026Article
- Sponsor Initiated Requests to Delay Pediatric Postmarketing Studies.Pharmaceutical medicine · 2026Article
- Measuring What Matters in Trial Operations: Development and Validation of the Clinical Trial Site Performance Measure.Journal of clinical medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Clinical trials (CTs) are essential for medical advancements, yet their increasing complexity and cost demand improved efficiency in trial management. One major challenge in multicenter studies is the inconsistency in evaluating site performance. This study aims to develop and validate a Clinical Trial Site Performance Measure (CT-SPM) to assess "good performance" across trials. The tool will be tested and refined through psychometric analysis, resulting in both a comprehensive scale and a short form for universal application. The study is conducted in three phases: Phase 1 involves metric selection through expert consensus; Phase 2 focuses on psychometric testing to evaluate the reliability and validity of the instrument; and Phase 3 defines a cut-off for "good performance" using statistical models. This protocol aims to standardize site performance evaluation, potentially reducing research costs and enhancing trial quality.•The study develops and validates a Clinical Trial Site Performance Measure (CT-SPM) using expert consensus and psychometric testing.•A comprehensive and short-form tool will be created to evaluate site performance in multicenter clinical trials.•A cut-off for "good performance" will be established using statistical models, facilitating consistent and efficient site evaluations.
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.