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Updated: Jul 9, 2025
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Methodology for Establishing a Community-Wide Life Laboratory for Capturing Unobtrusive and Continuous Remote Activity and Health Data
Published on: July 27, 2018
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Clinical research in the community.
Ruemu Ejedafeta Birhiray1, Maya Nicole Birhiray2
1Hematology Oncology of Indiana/American Oncology Network, PA, and Marian University College of Osteopathic Medicine, Indianapolis, IN.
Hematology. American Society of Hematology. Education Program
|December 9, 2023
Summary
Clinical trial access for high-risk hematologic malignancies remains limited in community oncology settings, contributing to persistent health disparities. New initiatives aim to broaden patient enrollment and improve treatment availability for diverse populations.
Area of Science:
- Hematologic Malignancies
- Oncology Clinical Trials
- Health Disparities
Background:
- Most high-risk hematologic malignancy patients receive care in community oncology practices due to patient preference and trust.
- Complex treatments and limited clinical trial access at community sites contribute to outcome disparities, especially for minority, rural, and elderly patients.
- Despite National Cancer Institute (NCI) programs since 2003, disparities in clinical trial participation, particularly in pharmaceutical research, have persisted.
Purpose of the Study:
- To analyze the persistent disparities in clinical trial access for high-risk hematologic malignancies in community oncology practices.
- To evaluate the impact of previous NCI initiatives and recent legislative actions on clinical trial enrollment.
- To propose strategies for improving clinical trial availability and representation in community settings.
Main Methods:
- Review of National Cancer Institute (NCI) programs and legislative actions (e.g., FDA Omnibus Act 2022) aimed at improving clinical trial diversity.
- Analysis of factors contributing to underrepresentation in clinical trials for high-risk hematologic malignancies.
- Examination of persistent disparities in pharmaceutical-directed clinical research.
Main Results:
- Past NCI programs (2003-2023) have not fully resolved disparities in clinical trial access for high-risk hematologic malignancies.
- Underrepresentation in clinical research leads to data gaps and delayed treatment availability in community practices.
- The FDA Omnibus Act of 2022 aims to address these disparities through mandated diversity plans.
Conclusions:
- Continued disparities highlight the need for enhanced strategies to integrate clinical trials into community oncology.
- Adoption of initiatives like the DRIVE strategy and leveraging NCI programs can promote trial availability.
- Improving clinical trial access in community settings is crucial for equitable outcomes in high-risk hematologic malignancies.
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