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Exploring Barriers to Pediatric Cancer Clinical Trials: The Role of a Networked, Just-in-Time Study Program
Zachary Rivers1, Ben Hyde1, Karyn Ronski1
1Tempus Labs, 600 W Chicago, Chicago, IL 60654.
Abstract:
The Research to Accelerate Cures and Equity (RACE) for Children Act mandates that newly developed targeted oncology drugs be tested in children when molecular targets are relevant to pediatric cancers. In its first year, the RACE for Children Act was effective in creating novel drug development opportunities for children with cancer; however, significant barriers to clinical trial enrollment persist. Pediatric cancer clinical trials are impacted by challenges surrounding logistics, complexity, and access. As such, there is potential for a networked and centralized study approach to address these barriers. Here we discuss adapting a just-in-time clinical trial approach for adults to serve the pediatric oncology population. Through innovative patient matching solutions leveraging large, real-world datasets with high computational power, the Tempus Integrated Molecular Evaluation (TIME) for Kids Program aims to address barriers in the development of new therapies. This commentary explores the potential for reducing challenges in developing novel pediatric therapeutics, advancing equity in genomic biomarker testing for precision tailored treatment, and improving outcomes for pediatric oncology patients.
Insights
The RACE for Children Act aims to improve pediatric cancer drug development. A new approach using real-world data and patient matching could overcome clinical trial enrollment barriers for children with cancer.
Area of Science:
- Pediatric Oncology
- Genomic Medicine
- Clinical Trial Design
Background:
- The Research to Accelerate Cures and Equity (RACE) for Children Act promotes pediatric testing of targeted oncology drugs.
- Despite the act, pediatric cancer clinical trials face persistent enrollment challenges due to logistics, complexity, and access.
- A networked and centralized study approach may address these barriers.
Purpose of the Study:
- To adapt a just-in-time clinical trial approach for pediatric oncology.
- To leverage real-world data and computational power for patient matching.
- To reduce challenges in developing novel pediatric therapeutics and improve patient outcomes.
Main Methods:
- Adapting an adult just-in-time clinical trial model for pediatric use.
- Utilizing innovative patient matching solutions.
- Leveraging large, real-world datasets and high computational power through the Tempus Integrated Molecular Evaluation (TIME) for Kids Program.
Main Results:
- The RACE for Children Act has created new drug development opportunities for pediatric cancer.
- Significant barriers to clinical trial enrollment for children with cancer remain.
- The TIME for Kids Program aims to address these barriers through innovative solutions.
Conclusions:
- A networked, centralized, and just-in-time approach can overcome pediatric clinical trial enrollment barriers.
- Innovative patient matching using real-world data can accelerate the development of new pediatric cancer therapies.
- Improving genomic biomarker testing and access can advance precision treatment and enhance outcomes for pediatric oncology patients.
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