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Benchmarking Protocol Deviations and Their Variation by Major Disease Categories
Kenneth Getz1, Zachary Smith2, Ananya Jain3
1Tufts Center for the Study of Drug Development, Tufts University School of Medicine, 145 Harrison Avenue, Boston, MA, 02111, USA. Kenneth.getz@tufts.edu.
Therapeutic Innovation & Regulatory Science
|April 5, 2022
Summary
Clinical trial protocols frequently experience deviations, impacting about a third of patients. Oncology trials show the highest deviation rates, with more sites increasing protocol deviations.
Area of Science:
- Clinical trial management
- Drug development operations
- Regulatory compliance
Background:
- Limited data exist on quantifying and benchmarking protocol deviation frequency in clinical trials.
- Understanding protocol deviations is crucial for ensuring data integrity and patient safety.
Purpose of the Study:
- To quantify and benchmark the magnitude of protocol deviations in clinical trials.
- To identify factors associated with protocol deviations.
Main Methods:
- Data from 187 protocols were collected from nearly two dozen companies.
- Analysis focused on protocol design and performance metrics.
Main Results:
- Phase II and III protocols averaged 75 and 119 deviations, respectively, affecting nearly one-third of patients.
- Oncology trials had the highest deviation rates, impacting over 40% of patients.
- Increased number of investigative sites, endpoints, procedures per visit, and countries were associated with higher deviation rates.
Conclusions:
- Study provides benchmarks for sponsors to assess their protocol deviation experience.
- Identifies key factors associated with deviations, aiding in remediation strategies.
- Highlights the need for proactive management of protocol deviations.
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