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Published on: August 1, 2019
Pragmatic patient engagement in designing pragmatic oncology clinical trials
Bernard Bright Davies-Teye1,2, Michelle Medeiros1,2, Cynthia Chauhan2
1Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD 21201, USA.
Abstract:
Oncology trials are the cornerstone of effective and safe therapeutic discoveries. However, there is increasing demand for pragmatism and patient engagement in the design, implementation and dissemination of oncology trials. Many researchers are uncertain about making trials more practical and even less knowledgeable about how to meaningfully engage patients without compromising scientific rigor to meet regulatory requirements. The present work provides practical guidance for addressing both pragmaticism and meaningful patient engagement. Applying evidence-based approaches like PRECIS-2-tool and the 10-Step Engagement Framework offer practical guidance to make future trials in oncology truly pragmatic and patient-centered. Consequently, such patient-centered trials have improved participation, faster recruitment and greater retention, and uptake of innovative technologies in community-based care.
Insights
This study offers practical guidance for designing pragmatic and patient-centered oncology trials. Implementing tools like PRECIS-2 and the 10-Step Engagement Framework can improve trial participation and efficiency.
Area of Science:
- Clinical Trials
- Oncology Research
- Patient-Centered Care
Background:
- Oncology trials are crucial for therapeutic advancements but face increasing demands for pragmatism and patient engagement.
- Researchers often lack clear strategies for enhancing trial practicality and meaningful patient involvement while maintaining scientific rigor.
Purpose of the Study:
- To provide practical guidance for making oncology trials more pragmatic and patient-centered.
- To address researcher uncertainty regarding the integration of patient engagement without compromising scientific standards.
Main Methods:
- Utilized evidence-based approaches, specifically the PRECIS-2 tool.
- Applied the 10-Step Engagement Framework for practical implementation guidance.
Main Results:
- The proposed methods offer a structured approach to enhance trial design and execution.
- Patient-centered oncology trials demonstrated improvements in participation, recruitment speed, and patient retention.
Conclusions:
- The PRECIS-2 tool and 10-Step Engagement Framework provide actionable strategies for pragmatic, patient-centered oncology trials.
- Implementing these approaches can lead to wider adoption of innovative cancer therapies in community settings.
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