New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance
Kenneth Getz1, Zachary Smith2, Emily Botto2
1Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, USA. kenneth.getz@tufts.edu.
Therapeutic Innovation & Regulatory Science
|March 4, 2024
Summary
Clinical trial amendments are increasing, with more than 76% of protocols now requiring changes. These amendments, often unavoidable, significantly impact trial timelines and performance, especially during pandemics.
Area of Science:
- Clinical trial management
- Pharmaceutical research
- Regulatory affairs
Background:
- Protocol amendments are common in clinical trials.
- The COVID-19 pandemic has potentially impacted amendment trends.
Purpose of the Study:
- To assess trends in clinical trial protocol amendment experiences.
- To evaluate the impact of amendments on clinical trial performance.
- To analyze amendment trends during the COVID-19 pandemic.
Main Methods:
- Follow-up study conducted by Tufts CSDD in 2022.
- Data collected from 16 pharmaceutical companies and CROs.
- Analysis of 950 protocols and 2188 amendments across phases I-IV.
Main Results:
- Prevalence of amended protocols increased from 57% to 76% since 2015.
- Mean amendments per protocol rose to 3.3 (from 2.1), a 60% increase.
- Amendment implementation time nearly tripled; average duration is 260 days.
- 77% of amendments were unavoidable, driven by regulatory and strategic changes.
- Amended protocols showed increased patient screening and reduced enrollment deviations.
- Protocols during the pandemic had significantly more amendments.
Conclusions:
- Clinical trial amendments are becoming more frequent and complex.
- Amendments significantly affect trial duration and operational efficiency.
- Regulatory and strategic changes are primary drivers for amendments.
- Pandemic conditions exacerbated amendment trends and their impact.
Keywords:
Clinical trial executionProtocol amendmentsProtocol complexityProtocol designProtocol optimizationMore Related Videos
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