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Related Experiment Videos

Clinical trial design for target-based therapy.

Elizabeth Fox1, Gregory A Curt, Frank M Balis

  • 1Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, USA. foxb@mail.nih.gov

The Oncologist
|October 29, 2002
PubMed
Summary
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Anticancer drug discovery now uses targeted approaches based on molecular understanding. Clinical trials for these novel drugs require new endpoints beyond traditional toxicity and response measures.

Area of Science:

  • Oncology
  • Pharmacology
  • Molecular Biology

Background:

  • Anticancer drug discovery has evolved from random screening to a rational, target-based approach.
  • Advances in understanding cancer pathogenesis at the molecular level provide new drug targets.

Purpose of the Study:

  • To discuss the necessary changes in clinical trial design for target-based anticancer drugs.
  • To highlight the limitations of traditional endpoints for novel therapeutic agents.

Main Methods:

  • Review of traditional and proposed clinical trial endpoints for anticancer drugs.
  • Discussion of the shift towards mechanistic and molecularly targeted therapies.

Main Results:

  • Traditional endpoints like toxicity and response may be insufficient for cytostatic, target-based agents.

Related Experiment Videos

  • Biological or pharmacokinetic endpoints are proposed for early-phase trials (Phase I and II).

    • Conclusions:

    • Phase III trials will still prioritize measurable clinical benefit.
    • Adapting clinical trial designs is crucial for evaluating the utility of new targeted anticancer drugs.