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Related Experiment Videos

Phase 0 trials: an industry perspective.

Helen Eliopoulos1, Vincent Giranda, Robert Carr

  • 1Abbott Laboratories, Abbott Park, Illinois, USA.

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
|June 19, 2008
PubMed
Summary
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Phase 0 trials accelerate oncology drug development by providing early human data on pharmacokinetics and pharmacodynamics. This approach helps prioritize promising compounds and refine subsequent trial designs.

Area of Science:

  • Oncology
  • Clinical Pharmacology
  • Drug Development

Background:

  • Cancer remains a leading cause of death globally, driving the need for efficient drug development.
  • Despite advances, new targeted cancer therapies face high costs and lengthy development timelines.
  • Most drug candidates fail before Phase III trials, highlighting inefficiencies in the drug development pipeline.

Purpose of the Study:

  • To review the utility and benefits of exploratory or Phase 0 clinical trials in oncology drug development.
  • To examine how Phase 0 trials can enhance the efficiency of bringing new cancer therapies to market.
  • To present a case study of ABT-888, a poly (ADP-ribose) polymerase inhibitor, developed using a Phase 0 trial design.

Main Methods:

  • Review of the concept and rationale behind Phase 0 trials.

Related Experiment Videos

  • Analysis of pharmacokinetic and pharmacodynamic data obtained from Phase 0 studies.
  • Case study illustrating the application of Phase 0 trials in early drug development.

    • Main Results:

    • Phase 0 trials enable early assessment of drug behavior in humans, informing go/no-go decisions.
    • Data from Phase 0 studies can optimize the design of subsequent Phase I trials.
    • The use of Phase 0 trials can potentially reduce attrition rates and development costs for oncology drugs.

    Conclusions:

    • Phase 0 trials offer significant advantages for pharmaceutical companies by providing crucial early data.
    • These trials can de-risk drug development and accelerate the identification of effective cancer therapies.
    • Wider adoption of Phase 0 trials is recommended to improve the efficiency of oncology drug development.