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Accelerating anticancer drug development - opportunities and trade-offs
Sharyl J Nass1, Mace L Rothenberg2, Rebecca Pentz3
1Health and Medicine Division, National Academies of Sciences, Engineering and Medicine, Washington, DC, USA. snass@nas.edu.
Nature Reviews. Clinical Oncology
|October 3, 2018
Summary
Precision medicine in oncology requires adaptive drug development. Novel trial designs and data strategies can accelerate therapeutic access while ensuring safety and efficacy information is continuously gathered.
Area of Science:
- Oncology
- Drug Development
- Clinical Trials
Background:
- Traditional oncology drug development faces challenges with the rise of precision medicine and patient stratification.
- The precision medicine paradigm necessitates more adaptive and efficient clinical trial designs.
Purpose of the Study:
- To explore novel strategies for improving the efficiency of oncology drug development.
- To identify new mechanisms for gathering information on anticancer therapies throughout their lifecycle.
Main Methods:
- Review of current drug development paradigms in oncology.
- Discussion of novel trial designs and modeling strategies.
- Exploration of innovative data acquisition methods like functional imaging and real-world data.
Main Results:
- Seamless trial designs offer accelerated access to novel oncology therapeutics.
- Trade-offs include limited early-stage information on clinical benefit and safety.
- Opportunities exist to enhance efficiency and data collection throughout the drug lifecycle.
Conclusions:
- Adaptive and seamless approaches are crucial for modern oncology drug development.
- Integrating novel trial designs, modeling, imaging, and real-world data can optimize drug development efficiency and information gathering.
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