ArticleTherapeutic innovation & regulatory science2026
Beyond prediction: an evidenced-based framework for assessing site selection decisions.
Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
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Who cites it
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Corrections and comments
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Authors and funding
3 authors.
Funding
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Abstract
backgroundClinical trial success depends on selecting appropriate sites, yet current selection approaches, often predictive and profile-based, exhibit systematic problems where sites with similar profiles demonstrate inconsistent performance.
methodBased on interviews with sponsors, CROs, and sites, along with a literature review, we developed a framework that explains, rather than predicts, site performances. It distinguishes between site inputs (resources and operating environment), dynamic capabilities (coordinated site-level abilities), and outputs (performance metrics).
resultsAnalysis revealed a circular reasoning problem in feasibility projections where sites self-assess their own performance potential. Real-world examples demonstrate that practitioners are intuitively applying our model's principles, indicating readiness for more systematic framework.
conclusionOur model's framework offers actionable insights for improving both individual selection decisions and systematic selection processes, supporting from prospective site selection to ongoing performance diagnosis throughout the trial lifecycle.
Indexed as
Identifiers
42732041What 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.