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Developing systems for cost-effective auditing of clinical trials
R M Califf1, S L Karnash, L H Woodlief
1Clinical Research Institute, Duke University Medical Center, Durham, North Carolina 27705, USA.
Controlled Clinical Trials
|December 31, 1997
Summary
This study introduces cost-effective clinical trial auditing methods. By integrating trials with clinical practice and using targeted data collection and sampling, costs can be reduced without compromising quality.
Area of Science:
- Clinical research methodology
- Healthcare economics
Background:
- Clinical trial auditing is crucial for data reliability but traditionally expensive.
- High auditing costs significantly increase overall clinical trial expenses.
Purpose of the Study:
- To describe cost-effective strategies for clinical trial monitoring.
- To maintain trial quality while reducing associated costs.
Main Methods:
- Integrating clinical trial monitoring with routine clinical practice.
- Implementing focused data collection strategies.
- Utilizing sampling methods for source document review instead of complete verification.
- Applying prospective clinical judgment to identify high-risk trial areas.
Main Results:
- Proposed methods can significantly reduce the costs of clinical trial auditing.
- Cost reductions can be achieved without compromising the quality and reliability of trial data.
- Integrated and sampled approaches offer a more efficient monitoring model.
Conclusions:
- Cost-effective clinical trial auditing is achievable through innovative monitoring strategies.
- Integrating trials into clinical practice and selective data review are key to reducing expenses.
- These approaches ensure trial integrity and data quality while lowering overall costs.