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Highly effective cystic fibrosis clinical research teams: critical success factors
George Z Retsch-Bogart1, Jill M Van Dalfsen, Bruce C Marshall
1Division of Pulmonology, Department of Pediatrics, University of North Carolina at Chapel Hill, 450 MacNider, CB#7217, 333 South Columbia Street, Chapel Hill, NC, 27599-7217, USA, gzrb@med.unc.edu.
Background:
Bringing new therapies to patients with rare diseases depends in part on optimizing clinical trial conduct through efficient study start-up processes and rapid enrollment. Suboptimal execution of clinical trials in academic medical centers not only results in high cost to institutions and sponsors, but also delays the availability of new therapies. Addressing the factors that contribute to poor outcomes requires novel, systematic approaches tailored to the institution and disease under study.
Objective:
To use clinical trial performance metrics data analysis to select high-performing cystic fibrosis (CF) clinical research teams and then identify factors contributing to their success.
Design:
Mixed-methods research, including semi-structured qualitative interviews of high-performing research teams.
Participants:
CF research teams at nine clinical centers from the CF Foundation Therapeutics Development Network.
Approach:
Survey of site characteristics, direct observation of team meetings and facilities, and semi-structured interviews with clinical research team members and institutional program managers and leaders in clinical research.
Key Results:
Critical success factors noted at all nine high-performing centers were: 1) strong leadership, 2) established and effective communication within the research team and with the clinical care team, and 3) adequate staff. Other frequent characteristics included a mature culture of research, customer service orientation in interactions with study participants, shared efficient processes, continuous process improvement activities, and a businesslike approach to clinical research.
Conclusions:
Clinical research metrics allowed identification of high-performing clinical research teams. Site visits identified several critical factors leading to highly successful teams that may help other clinical research teams improve clinical trial performance.
Insights
High-performing cystic fibrosis research teams excel due to strong leadership, effective communication, and adequate staffing. Identifying these factors can improve clinical trial performance for rare diseases.
Area of Science:
- Clinical Research
- Rare Diseases
- Therapeutics Development
Background:
- Optimizing clinical trial conduct is crucial for rare disease therapy development.
- Inefficient clinical trials in academic centers increase costs and delay new treatments.
- Systematic approaches are needed to address poor clinical trial outcomes.
Purpose of the Study:
- To identify high-performing cystic fibrosis (CF) clinical research teams using performance metrics.
- To determine the key factors contributing to the success of these CF research teams.
Main Methods:
- Mixed-methods research combining quantitative performance metrics with qualitative data.
- Analysis of clinical trial performance metrics across nine CF Foundation Therapeutics Development Network centers.
- Semi-structured interviews, surveys, and direct observations of research teams and their environments.
Main Results:
- Strong leadership, effective team communication (research and clinical), and adequate staffing were critical success factors.
- Other key characteristics included a mature research culture, participant-focused customer service, efficient processes, and continuous improvement.
- High-performing teams demonstrated a businesslike approach to clinical research operations.
Conclusions:
- Clinical research metrics effectively identify top-performing teams.
- Site-based qualitative assessments reveal actionable factors for improving clinical trial performance.
- These findings can guide other research teams in enhancing their efficiency and success rates.
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