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Biostatistical and Logistical Considerations in the Development of Basket and Umbrella Clinical Trials

Laura M Yee1, Lisa M McShane, Boris Freidlin

  • 1From the Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.

Cancer Journal (Sudbury, Mass.)
|July 24, 2019
PubMed

Insights

Precision oncology medicine utilizes complex clinical trial designs like multiarm basket and umbrella trials to efficiently evaluate targeted cancer therapies. These innovative approaches require integrated expertise for successful planning, execution, and analysis.

Area of Science:

  • Oncology
  • Clinical Trial Design
  • Precision Medicine

Background:

  • Oncology clinical trials are evolving to assess targeted therapies for diverse, biologically defined cancer subgroups.
  • Master protocols, including multiarm basket and umbrella trials, are increasingly used for evaluating novel anticancer agents.

Purpose of the Study:

  • To highlight the prominence and efficiency of multiarm basket and umbrella trials in precision oncology.
  • To discuss the complexities and necessary considerations for designing and conducting these advanced trial structures.

Main Methods:

  • Utilizing master protocols to facilitate the evaluation of multiple therapies across various cancer types.
  • Integrating biomarker assay platforms and robust data processing for patient stratification into substudies.
  • Emphasizing the need for statistical design, monitoring, and analysis tailored to complex substudy structures.

Main Results:

  • These trial designs enable efficient evaluation of targeted therapies in biologically defined cancer populations.
  • Successful implementation requires multidisciplinary teams with expertise in biology, clinical oncology, bioinformatics, and statistics.

Conclusions:

  • Multiarm basket and umbrella trials are essential for advancing precision oncology medicine.
  • Continued evolution of strategies for design, conduct, and analysis is crucial to address future challenges and opportunities in targeted cancer therapy evaluation.

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