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Clinical trials in the era of personalized oncology
Michael L Maitland1, Richard L Schilsky
1Section of Hematology/Oncology, Committee on Clinical Pharmacology and Pharmacogenomics, University of Chicago, IL 60637, USA.
Abstract:
The rapid pace of discoveries in tumor biology, imaging technology, and human genetics hold promise for an era of personalized oncology care. The successful development of a handful of new targeted agents has generated much hope and hype about the delivery of safer and more effective new treatments for cancer. The design and conduct of clinical trials has not yet adjusted to a new era of personalized oncology and so we are more in transition to that era than in it. With the development of treatments for breast cancer as a model, we review the approaches to clinical trials and the development of novel therapeutics in the prior era of population oncology, the current transitional era, and the future era of personalized oncology.
Insights
Personalized oncology offers hope for better cancer treatments. Clinical trial designs are transitioning to match advances in tumor biology and genetics for tailored therapies.
Area of Science:
- Oncology
- Genetics
- Medical Imaging
Background:
- Advances in tumor biology, imaging, and genetics are paving the way for personalized cancer care.
- New targeted therapies show promise for safer and more effective cancer treatments.
- Current clinical trial designs lag behind the rapid pace of oncological advancements.
Purpose of the Study:
- To review clinical trial approaches and therapeutic development in oncology.
- To contrast population-based oncology with the emerging era of personalized oncology.
- To examine the transition from traditional to personalized cancer treatment strategies.
Main Methods:
- Review of clinical trial designs and therapeutic development strategies.
- Analysis of breast cancer treatment evolution as a model.
- Comparison of past, present (transitional), and future approaches in oncology.
Main Results:
- The field is transitioning from population-based to personalized oncology.
- Clinical trials need adaptation to effectively evaluate targeted therapies.
- Breast cancer serves as a key model for understanding this transition.
Conclusions:
- Personalized oncology requires a paradigm shift in clinical trial design.
- Integrating genomic and imaging data is crucial for future cancer therapeutics.
- The future of cancer care lies in tailored treatments based on individual patient profiles.
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