Optimizing preclinical study design in oncology research

Luke Anthony Wittenburg, Daniel L. Gustafson

Research output: Contribution to journalReview article

6 Citations (Scopus)

Abstract

The current drug development pathway in oncology research has led to a large attrition rate for new drugs, in part due to a general lack of appropriate preclinical studies that are capable of accurately predicting efficacy and/or toxicity in the target population. Because of an obvious need for novel therapeutics in many types of cancer, new compounds are being investigated in human Phase I and Phase II clinical trials before a complete understanding of their toxicity and efficacy profiles is obtained. In fact, for newer targeted molecular agents that are often cytostatic in nature, the conventional preclinical evaluation used for traditional cytotoxic chemotherapies utilizing primary tumor shrinkage as an endpoint may not be appropriate. By utilizing an integrated pharmacokinetic/pharmacodynamic approach, along with proper selection of a model system, the drug development process in oncology research may be improved leading to a better understanding of the determinants of efficacy and toxicity, and ultimately fewer drugs that fail once they reach human clinical trials.

Original languageEnglish (US)
Pages (from-to)73-78
Number of pages6
JournalChemico-Biological Interactions
Volume190
Issue number2-3
DOIs
StatePublished - Apr 25 2011
Externally publishedYes

Fingerprint

Oncology
Toxicity
Research
Pharmaceutical Preparations
Pharmacodynamics
Phase II Clinical Trials
Pharmacokinetics
Chemotherapy
Health Services Needs and Demand
Cytostatic Agents
Tumors
Neoplasms
Clinical Trials
Drug Therapy
Therapeutics

Keywords

  • Oncology
  • Pharmacodynamics
  • Pharmacokinetics
  • Preclinical study

ASJC Scopus subject areas

  • Toxicology

Cite this

Optimizing preclinical study design in oncology research. / Wittenburg, Luke Anthony; Gustafson, Daniel L.

In: Chemico-Biological Interactions, Vol. 190, No. 2-3, 25.04.2011, p. 73-78.

Research output: Contribution to journalReview article

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