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Updated: Jun 23, 2026
08:46
Implementation of In Vitro Drug Resistance Assays: Maximizing the Potential for Uncovering Clinically Relevant Resistance Mechanisms
Published on: December 9, 2015
Next generation oncology drug development: opportunities and challenges
Martin E Gutierrez1, Shivaani Kummar, Giuseppe Giaccone
1National Cancer Institute, NIH, Bethesda, MD 20892, USA.
Nature Reviews. Clinical Oncology
|April 25, 2009
Summary
Developing new molecularly targeted cancer therapies requires rethinking current drug development. This review examines patient selection, dosing, response definition, and trial designs for early-phase oncology therapeutics.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Current cancer drug development faces challenges in optimizing novel molecularly targeted agents.
- Key areas of debate include patient selection, dosing strategies, and defining clinical benefit.
Purpose of the Study:
- To review the opportunities and challenges in oncology drug development.
- To examine the early phases of clinical development, including first-in-human trials.
Main Methods:
- Literature review of current practices and debates in early cancer therapeutics.
- Analysis of key considerations in oncology drug development.
Main Results:
- Identified critical areas for re-evaluation in the drug development paradigm.
- Highlighted the importance of patient selection, optimal biologic dose, and response definition.
Conclusions:
- Optimizing novel molecularly targeted cancer agents necessitates a revised drug development approach.
- Addressing trial design and early therapeutic considerations is crucial for advancing cancer treatment.
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