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Updated: May 21, 2026
07:46
Microfluidic Co-Culture Models for Dissecting the Immune Response in in vitro Tumor Microenvironments
Published on: April 30, 2021
How to develop treatments for biologically heterogeneous "diseases".
1Biometric Research Branch, Division of Cancer Treatment & Diagnosis, National Cancer Institute, Bethesda, Maryland, USA. rsimon@nih.gov
Summary
Standard phase III clinical trial designs fail for targeted cancer therapies in diverse patient groups. A new framework using tumor genomics can improve the design of future phase III trials for molecularly targeted treatments.
Area of Science:
- Oncology
- Clinical Trial Design
- Genomics
Background:
- The current phase III clinical trial paradigm is inadequate for evaluating molecularly targeted treatments.
- Patient populations in oncology are often biologically heterogeneous, complicating standard trial designs.
Purpose of the Study:
- To address the limitations of standard phase III trial designs for molecularly targeted therapies.
- To propose an alternative framework for phase III trials that incorporates tumor genomics.
Main Methods:
- Review of existing phase III clinical trial designs.
- Proposal of a prospective discovery/evaluation framework.
Main Results:
- The standard phase III design is unsuitable for heterogeneous patient groups receiving targeted treatments.
- A novel framework is proposed to integrate tumor genomics into phase III trial design.
Conclusions:
- Alternative clinical trial designs are necessary for molecularly targeted treatments.
- Integrating tumor genomics into a prospective framework can optimize phase III trial design for precision oncology.
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