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June 10, 2026Clinical and Translational ScienceOpen Access

Tumor‐Specific Success Probabilities and Factors Associated With Phase III Trials in Oncology Drug Development

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Authors

KYKeiko YamamotoHokkaido UniversityAIAya IwaseMeiji Pharmaceutical UniversityHMHideki MaedaMeiji Pharmaceutical University

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Overview

Randomized trial evaluates factors affecting success probabilities in oncology, suggesting design improvements.

Key Points

  • This research aims to characterize success probabilities in Phase III oncology trials and identify factors influencing trial outcomes.
  • Analyzed 824 Phase III interventional oncology trials from ClinicalTrials.gov (2007-2023) with results available.
  • Defined trial success as achieving at least one primary endpoint and calculated tumor-specific success probabilities.
  • Conducted multivariable logistic regression analyses to assess associations between trial characteristics and success.
  • Overall success probability for trials was low, with 358 successful and 466 unsuccessful.
  • Central nervous system tumors and pancreatic cancer showed significantly lower success probabilities.
  • Factors like biomarker-based selection and trial design correlated with higher success probabilities.

Cite This Study

Yamamoto et al. (2026) studied this question.

synapsesocial.com/papers/6a28ff336f82f25be989c440https://doi.org/10.1111/cts.70635
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