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Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials.
Abigail Dirks1, Maria Florez2, Francois Torche3
1Tufts Center for the Study of Drug Development, Tufts School of Medicine, Boston, MA, USA. abigail.dirks@tufts.edu.
Therapeutic Innovation & Regulatory Science
|February 17, 2024
Summary
Risk-based quality management (RBQM) enhances clinical trial efficiency by focusing on critical data risks. Despite regulatory encouragement, adoption faces barriers like lack of knowledge and poor change management, hindering its widespread implementation.
Area of Science:
- Clinical Trials
- Drug Development
- Regulatory Science
Background:
- Risk-based monitoring (RBM) and risk-based quality management (RBQM) are encouraged by FDA and EMA since 2013.
- These approaches aim to improve clinical trial efficiency, speed, and quality by managing risks to safety and efficacy data.
- However, adoption of RBM/RBQM has been slow due to poorly understood barriers.
Purpose of the Study:
- To investigate the adoption levels of RBQM practices in the pharmaceutical industry.
- To identify the primary barriers hindering the implementation of RBQM.
- To provide insights for improving RBQM adoption rates.
Main Methods:
- An online survey was conducted by the Tufts Center for the Study of Drug Development.
- The survey targeted pharmaceutical, biotechnology, and contract research organizations.
- 206 responses were collected, detailing the adoption of 32 distinct RBQM practices.
Main Results:
- RBQM was implemented in an average of 57% of clinical trials across surveyed organizations.
- Companies conducting over 100 trials annually showed higher adoption (63%) compared to those conducting fewer than 25 trials (48%).
- Key barriers included lack of organizational knowledge, unclear value proposition, and inadequate change management.
Conclusions:
- Organizational knowledge, clear communication of RBQM benefits, and effective change management are crucial for successful adoption.
- Tailored strategies are needed to overcome identified barriers and increase RBQM implementation.
- Further research can explore specific interventions to enhance RBQM uptake and its impact on clinical trial quality.
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