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Published on: March 20, 2021
Biomarker-driven patient selection for early clinical trials
Rodrigo Dienstmann1, Jordi Rodon, Josep Tabernero
1Molecular Therapeutics Research Unit, Medical Oncology Department, Universitat Autònoma de Barcelona, Vall d'Hebron University Hospital, Barcelona, Spain.
Current Opinion in Oncology
|March 16, 2013
Summary
Biomarker-driven drug development uses enrichment strategies for personalized oncology. This approach accelerates drug approval and offers new therapies for advanced cancer patients, despite facing challenges.
Area of Science:
- Oncology
- Genetics
- Pharmacology
Background:
- Personalized oncology relies on advances in tumor biology and human genetics.
- Targeted therapies and driver event identification are key to precision medicine.
Purpose of the Study:
- To describe biomarker-driven early drug development using enrichment and prescreening.
- To discuss technical, logistical, ethical, and financial challenges of this approach.
Main Methods:
- Review of current trends in early drug development.
- Analysis of biomarker integration in Phase I trials.
- Discussion of challenges and ethical considerations.
Main Results:
- Biomarker integration in early trials can identify target engagement and effective dosages.
- This approach may offer therapeutic opportunities for advanced cancer patients.
- It has the potential to accelerate the drug approval process.
Conclusions:
- Innovative trials based on biological hypotheses are crucial for future cancer treatment.
- Tumor heterogeneity and clonal evolution must be considered in drug development.
- Biomarker-driven strategies hold promise for advancing personalized oncology.
