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Integrating Early-Stage Drug Development with Clinical Networks; Challenges and Opportunities: The City of Hope
Miguel A Villalona-Calero1, Jyoti Malhotra1, Vincent Chung1
1City of Hope National Medical Center, Department of Medical Oncology, Duarte, CA 91010, USA.
Abstract:
Recent data suggest that patients with advanced cancer who participate in biomarker/genomically informed early-stage clinical trials experience clinical benefit. While most early-stage clinical trials are conducted in major academic centers, the majority of cancer patients in the United States are treated in community practices. Here, we describe ongoing efforts at the City of Hope Cancer Center to integrate our network community oncology clinical practices into our academic, centralized biomarker/genomic-driven, early-stage clinical trial program to build an understanding of the approaches that provide the benefits of early-stage clinical trial participation to community patients. Our efforts include three key initiatives: the development of a virtual "Refractory Disease" phase 1 trial matching televideo clinic, the construction of infrastructure to support the expansion of phase 1 clinical trials to a distant regional clinical satellite hub, and the implementation of an enterprise-wide precision medicine, germline, and somatic testing program. Our work at City of Hope may serve as an example to facilitate similar efforts at other institutions.
Insights
Community cancer patients can benefit from early-stage clinical trials. City of Hope is integrating community practices into its biomarker-driven trials to expand access and understanding for better patient outcomes.
Area of Science:
- Oncology
- Clinical Trials
- Precision Medicine
Background:
- Patients with advanced cancer benefit from biomarker/genomically informed early-stage clinical trials.
- Most early-stage clinical trials occur at academic centers, limiting access for community practice patients.
- Bridging this gap is crucial for equitable cancer care.
Purpose of the Study:
- To describe City of Hope's initiatives to integrate community oncology practices into its early-stage clinical trial program.
- To understand how to provide early-stage clinical trial benefits to community-based cancer patients.
- To serve as a model for other institutions.
Main Methods:
- Developing a virtual trial matching clinic for refractory diseases.
- Expanding phase 1 clinical trials to a regional satellite hub.
- Implementing enterprise-wide precision medicine, germline, and somatic testing.
Main Results:
- Ongoing efforts focus on integrating community oncology practices into academic clinical trials.
- Key initiatives include virtual clinics, satellite hub expansion, and comprehensive testing programs.
- The goal is to understand and replicate approaches that benefit community patients.
Conclusions:
- Integrating community practices into academic early-stage clinical trials can expand patient access.
- City of Hope's multi-pronged approach addresses logistical and infrastructural barriers.
- This model offers a framework for other institutions to improve community patient participation in clinical trials.
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