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Clinical trial design issues in the era of targeted therapies

Joan H Schiller1

  • 1University of Wisconsin. Madison, Wisconsin, USA. jhschill@wisc.edu

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
|June 26, 2004
PubMed

Insights

Developing new molecularly targeted therapies is crucial due to the lack of effective treatments. However, careful consideration of clinical trial design and endpoints is necessary for successful therapeutic development.

Area of Science:

  • Oncology
  • Clinical Pharmacology
  • Drug Development

Background:

  • The absence of effective treatments necessitates the creation of novel therapeutic strategies.
  • Molecularly targeted therapies represent a promising avenue for improved patient outcomes.

Purpose of the Study:

  • To highlight critical considerations in the design of clinical trials for new therapies.
  • To address the challenges associated with defining appropriate endpoints for molecularly targeted therapies.

Main Methods:

  • Review of current challenges in clinical trial design.
  • Analysis of endpoint selection for targeted therapy trials.

Main Results:

  • Identification of key issues in current clinical trial methodologies.
  • Discussion of the complexities in evaluating the efficacy of targeted agents.

Conclusions:

  • Effective development of molecularly targeted therapies requires careful attention to clinical trial design.
  • Standardization and innovation in trial endpoints are essential for advancing cancer treatment.

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