Exploring Barriers to Pediatric Cancer Clinical Trials: The Role of a Networked, Just-in-Time Study Program

•Tempus TIME for Kids brings the Just-in-Time trial model to pediatric cancer.•TIME for Kids modifies the TIME Program originally created for adults.•The program addresses barriers in pediatric cancer drug development. The Research to Accelerate Cures and Equity (RACE) for Children Act mandates that...

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Bibliographic Details
Published in:Clinical therapeutics 2023-11, Vol.45 (11), p.1148-1150
Main Authors: Rivers, Zachary, Hyde, Ben, Ronski, Karyn, Stearns, Duncan, Toll, Stephanie, Ritt, Kevin, Cooney, Matthew, Nimeiri, Halla, Federman, Noah, Kaneva, Kristiyana
Format: Article
Language:English
Subjects:
Adult
Biomarkers
Biomarkers, Tumor - therapeutic use
Cancer
Child
Children
Clinical trials
Collaboration
Drug Development
Editing
Enrollments
Equity
Humans
Just in time
Medical Oncology
Molecular oncology
Neoplasms - drug therapy
Neoplasms - genetics
Oncology
Patients
Pediatric cancer
Pediatrics
Supervision
Targeted therapy
Time and Motion Studies
Writing
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Summary:•Tempus TIME for Kids brings the Just-in-Time trial model to pediatric cancer.•TIME for Kids modifies the TIME Program originally created for adults.•The program addresses barriers in pediatric cancer drug development. 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.
ISSN:0149-2918
1879-114X
DOI:10.1016/j.clinthera.2023.08.022