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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Moving Beyond the Momentum: Innovative Approaches to Clinical Trial Implementation
Cathy Eng1, Emerson Y Chen2, Jane Rogers3
1Vanderbilt-Ingram Cancer Center, Nashville, TN.
Abstract:
Despite efforts to enhance enrollment and the merger of national cooperative groups, < 5% of patients with cancer will enroll into a clinical trial. Additionally, clinical trials are affected by a lack of diversity inclusive of minority patients, rural residents, or low-income individuals. COVID-19 further exacerbated known barriers of reduced physician-patient interaction, physician availability, trial activation and enrollment, financial resources, and capacity for conducting research. Based on the cumulative insight of academic and community clinical researchers, we have created a white paper identifying existing challenges in clinical trial conduct and have provided specific recommendations of sustainable modifications to improve efficiency in the activation and conduct of clinical trials with an overarching goal of providing improved access and care to our patients with cancer.
Insights
Clinical trial enrollment remains low (<5%) and lacks diversity, with COVID-19 worsening existing barriers. This white paper offers recommendations to improve clinical trial efficiency, activation, and patient access to cancer care.
Area of Science:
- Oncology
- Clinical Research
- Health Services Research
Background:
- Less than 5% of cancer patients enroll in clinical trials.
- Clinical trials face significant diversity challenges, excluding minority, rural, and low-income populations.
- The COVID-19 pandemic amplified existing barriers to clinical trial conduct, including reduced physician interaction and resources.
Purpose of the Study:
- To identify key challenges in clinical trial activation and conduct.
- To propose sustainable modifications for improving clinical trial efficiency.
- To enhance patient access to cancer clinical trials and improve care.
Main Methods:
- Synthesized insights from academic and community clinical researchers.
- Developed a white paper detailing challenges and recommendations.
- Focused on practical, sustainable solutions for trial conduct.
Main Results:
- Identified critical barriers in clinical trial enrollment and diversity.
- Provided actionable recommendations for enhancing trial efficiency.
- Highlighted the need for systemic changes to improve research conduct.
Conclusions:
- Addressing identified challenges is crucial for improving clinical trial participation.
- Sustainable modifications can streamline trial activation and conduct.
- Enhanced clinical trials are essential for equitable patient access and advanced cancer care.
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