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Updated: Feb 4, 2026

Assessing Specificity of Anticancer Drugs In Vitro
Published on: March 23, 2016
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.
Abstract:
The traditional approach to drug development in oncology, with discrete phases of clinical testing, is becoming untenable owing to expansion of the precision medicine paradigm, whereby patients are stratified into multiple subgroups according to the underlying cancer biology. Seamless approaches to drug development in oncology hold great promise of accelerating the accessibility of novel therapeutic agents to the public but are also accompanied by important trade-offs, including the limited availability of information on the clinical benefit and safety of novel agents at the time of market entry. In this Perspectives article, we describe several opportunities, in the form of novel trial designs or modelling strategies, to improve the efficiency of drug development in oncology, as well as new mechanisms to obtain information about anticancer therapies throughout their life cycle, such as innovative functional imaging techniques or the use of real-world clinical data.
Insights
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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