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Assessing the impact of protocol design changes on clinical trial performance
Kenneth A Getz1, Julia Wenger, Rafael A Campo
1Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Tufts University, 75 Kneeland Street, Suite 1100, Boston, MA 02111, USA. kenneth.getz@tufts.edu
American Journal of Therapeutics
|September 23, 2008
Summary
Clinical research protocols have become more complex, increasing site workload and worsening study performance. This trend highlights the need for simplified protocol designs to improve efficiency and outcomes in clinical trials.
Area of Science:
- Clinical research methodology
- Drug development and evaluation
Background:
- Protocol design is critical for clinical research success.
- Changes in protocol design over time and their impact on clinical trial performance have not been quantified.
Purpose of the Study:
- To quantify trends in clinical research protocol design.
- To assess the impact of these design trends on clinical trial performance.
Main Methods:
- Analysis of 10,038 unique phase 1-4 protocols (1999-2005).
- Analysis of study conduct performance for 57 phase 2 and 3 protocols at US sites.
- Measurement of procedure frequency, site work burden, cycle time, recruitment/retention rates, amendments, adverse events, and case report form length.
Main Results:
- Unique procedures per protocol increased by 6.5% annually.
- Procedure frequency increased by 8.7% annually.
- Investigative site work burden increased by 10.5% annually.
- Study conduct performance (cycle time, recruitment, retention) worsened.
- Protocol amendments, serious adverse events, and case report form length increased.
Conclusions:
- Clinical trial protocols have significantly increased in complexity between 1999 and 2005.
- Increased protocol complexity negatively impacts clinical trial conduct and performance.
- Simplifying protocol designs is necessary to mitigate negative effects on study efficiency and outcomes.
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