ArticleTherapeutic innovation & regulatory science2025
Futility Interim Analyses - A Plea for Simplicity.
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. 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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Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Futility interim analyses remain a topic of anxiety for most clinical drug development teams. While they can significantly reduce the risk involved in the development of innovative therapies and do so at a minimal cost, they are not used frequently enough. Development teams often shy away due to the fear of terminating a potentially successful therapy by mistake. We believe these risks are overestimated and hence necessitate a simple and effective communication to be better understood. The planning of futilities often evolves into complex statistical modeling exercises where various scenarios are simulated and multiple risk metrics are calculated. To assist teams in such discussions we propose a straightforward strategy for establishing a range for the futility threshold and an intuitive futility risk measure to evaluate the associated risks.
Indexed as
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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.