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Theory and practice of clinical pharmacodynamics in oncology drug development

Ralph E Parchment1, James H Doroshow2

  • 1Clinical Pharmacodynamics Program, Applied/Developmental Research Directorate, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, MD.

Seminars in Oncology
|September 25, 2016
PubMed

Insights

Clinical pharmacodynamics links molecular drug action to cancer treatment effectiveness. This review details its medical, lab, and trial aspects, emphasizing quality control for reliable oncology drug development.

Area of Science:

  • Oncology
  • Pharmacology
  • Translational Medicine

Background:

  • Molecularly targeted cancer therapies require proof of mechanism and concept.
  • Clinical pharmacodynamics connects drug action on targets to efficacy through cellular changes.

Purpose of the Study:

  • To introduce clinical pharmacodynamics (PD) in cancer research.
  • To outline its medical, laboratory, and clinical trial integration.
  • To highlight quality factors for robust PD studies.

Main Methods:

  • Review of clinical pharmacodynamics principles.
  • Discussion of integration into clinical trials.
  • Identification of key quality control measures.

Main Results:

  • Clinical PD bridges molecular pharmacology and clinical efficacy.
  • Essential quality factors include biopsy integrity, specimen handling, assay validation, and reagent control.
  • Well-conducted PD studies are crucial for oncology drug development.

Conclusions:

  • Clinical pharmacodynamics is vital for advancing targeted cancer therapies.
  • Adherence to quality standards ensures reliable assessment of drug effects.
  • This field enhances the development of effective oncology treatments.
Keywords:
Assay fitness-for-purposeBiopsy sample qualityBiopsy surrogate tissuesReagent quality control

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