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Are Phase 2 screening trials in oncology obsolete?

Eric Holmgren1

  • 1Genentech Inc., 1 DNA Way, South San Francisco, CA, USA. erich@gene.com

Statistics in Medicine
|July 31, 2007
PubMed

Insights

Phase 2 oncology trials can improve drug discovery efficiency but may hinder overall development if candidate identification costs are high. These studies are crucial for determining Phase 3 trial viability.

Area of Science:

  • Oncology
  • Clinical Trials
  • Drug Development

Background:

  • Phase 2 oncology studies face scrutiny due to limited power for activity assessment.
  • These trials serve as a critical screen for advancing to Phase 3 investigations.

Purpose of the Study:

  • To systematically assess the properties and efficiency of Phase 2 studies within drug development programs.
  • To evaluate the impact of Phase 2 screening on the overall efficiency of identifying beneficial oncology drugs.

Main Methods:

  • Systematic assessment of Phase 2 study properties.
  • Analysis of clinical trial program efficiency considering screening costs.

Main Results:

  • Phase 2 screening trials can significantly enhance the identification of drugs offering clinical benefit.
  • Conversely, high costs associated with identifying drug candidates may decrease overall development efficiency when using Phase 2 trials as a prelude to Phase 3.

Conclusions:

  • Phase 2 studies present a complex trade-off in oncology drug development.
  • Optimizing their role requires balancing screening efficiency with the costs of candidate identification for subsequent Phase 3 trials.

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