ArticleTherapeutic innovation & regulatory science2025
Hope is Not a Strategy: Using Robust Real-World Evidence to Make Better Clinical Development Decisions.
Article 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 1 paper.
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
1 citing paper in PubMed.
- Case Study on the Use of Real-World Evidence in a Feasibility Assessment of a Randomized Controlled Trial Design to Support the Fulfillment of Pediatric Requirements with the FDA and EMA.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
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Clinical development delays and failures do not serve public health. Reliance solely on expert opinion or historical patterns rather than evidence from representative, real-world point-of-care data about the indication results in suboptimal trial design, missed opportunities, and uninterpretable findings. Investment in real-world evidence (RWE) generation to build a deep, comprehensive, and current understanding of the characteristics, care, and outcomes of the indicated population is essential to improving clinical development decision making. Despite the recognized value of RWE, this evidence generation is not done systematically. Here we make integrated RWE generation more compelling and practicable by addressing concerns we have heard from biopharma leaders and, for emerging RWE leaders, providing a blueprint for designing real-world studies in a phased approach that aligns with clinical development investment. Our work is intended to facilitate more widespread adoption of integrated RWE generation, beginning early in development, so that robust RWE is in hand at the right time for evidence-based decision making by the sponsor, regulators, and payers.
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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.