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FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Optimized Dosages for Registrational

Stacy S Shord1, Cong Chen2, Jin Y Jin3

  • 1U.S. Food and Drug Administration, Silver Spring, Maryland.

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
|October 2, 2025
PubMed

Insights

Innovative trial designs and model-informed approaches can optimize oncology drug dosage selection, moving beyond traditional maximum tolerated dose (MTD) evaluations. These methods enhance efficiency and reduce toxicity for better patient outcomes in clinical trials.

Area of Science:

  • Oncology Drug Development
  • Clinical Trial Design
  • Pharmacometrics

Background:

  • The maximum tolerated dose (MTD) has been a standard for phase II oncology trials.
  • Targeted therapies may necessitate re-evaluating the MTD approach due to potential for excessive toxicity without added benefit.

Purpose of the Study:

  • To highlight the application and considerations of innovative trial designs and model-based approaches for optimizing oncology drug dosage selection.
  • To advocate for informed dosage selection in registrational trials beyond the MTD.

Main Methods:

  • Utilizing model-informed approaches like exposure-response analyses and clinical utility index.
  • Implementing innovative trial designs, such as seamless designs, for increased efficiency.
  • Leveraging comprehensive clinical and nonclinical data for dosage optimization.

Main Results:

  • Model-informed and innovative trial designs have been successfully applied to understand preliminary oncology drug data.
  • These approaches provide insights supporting optimized dosage selection for registrational trials.
  • Despite benefits, MTD evaluation remains prevalent in registrational oncology trials.

Conclusions:

  • Innovative trial designs and model-based strategies offer superior methods for optimizing oncology drug dosages.
  • Adopting these approaches can lead to more effective and safer oncology drug development.
  • Further integration of these methods is crucial for advancing oncology drug dosage selection practices.

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