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Embedding clinical trial elements into clinical practice: Experiences from trial designers and implementers
Carrie Dombeck1,2, Teresa Swezey1,2, Lindsay Kehoe1
1Clinical Trials Transformation Initiative, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Embedding clinical trials into routine care requires addressing staff time, buy-in, and data challenges. Solutions involve minimizing patient burden and fostering a culture change for efficient research and care integration.
Area of Science:
- Clinical research methodology
- Health services research
Background:
- Leveraging routine clinical data can enhance research and patient care.
- Embedding clinical trials into practice offers efficiency by reducing duplication.
- Cultural, administrative, and data barriers hinder integration.
Purpose of the Study:
- To explore motivations for embedding interventional, randomized trials into clinical practice.
- To identify barriers and solutions for implementing embedded trials.
Main Methods:
- Conducted 16 in-depth interviews (IDIs) with 18 trial designers and implementers.
- Analyzed interview data using applied thematic analysis.
Main Results:
- Motivations include establishing learning health systems and real-world trial evaluation.
- Key barriers: limited staff time, lack of buy-in, and electronic health record data issues.
- Proposed solutions: minimize patient/setting burden, ensure data infrastructure, and promote culture change.
Conclusions:
- Results informed Clinical Trials Transformation Initiative (CTTI) recommendations for embedded trials.
- Recommendations focus on rethinking trial design and conduct for research and care alignment.
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