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Monitoring strategies for clinical intervention studies
Katharina Klatte1, Christiane Pauli-Magnus1, Sharon B Love2
1Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
The Cochrane Database of Systematic Reviews
|December 8, 2021
Summary
Risk-based and central monitoring strategies show promise for clinical trials, potentially reducing costs without compromising data quality. Further research is needed to optimize these efficient approaches for better trial oversight.
Area of Science:
- Clinical Trial Management
- Evidence-Based Monitoring Strategies
- Good Clinical Practice (GCP)
Background:
- Effective trial monitoring is crucial for participant safety, data integrity, and regulatory compliance under Good Clinical Practice (GCP).
- The comparative effectiveness of various clinical trial monitoring strategies remains unclear, hindering optimal method selection.
- Evidence-based guidance is needed to help trialists and monitors adapt strategies to current knowledge.
Purpose of the Study:
- To evaluate the advantages and disadvantages of different clinical intervention study monitoring strategies.
- To compare risk-based monitoring and other approaches using prospective comparative studies of monitoring interventions.
Main Methods:
- Systematic literature search of CENTRAL, PubMed, and Embase up to March 2021, including grey literature and trial registries.
- Inclusion of prospective, empirical evaluation studies (randomized or non-randomized) of monitoring strategies in clinical intervention studies.
- Data extraction on monitoring methods, study characteristics, and outcomes (critical/major findings, recruitment, retention, resource use); meta-analysis where appropriate.
Main Results:
- Risk-based monitoring demonstrated non-inferiority to extensive on-site monitoring for critical/major findings, with significantly lower resource use and costs.
- Central monitoring with triggered on-site visits showed potential benefits over regular on-site visits, though evidence was limited.
- Targeted or remote source data verification (SDV) showed similar effectiveness to traditional 100% SDV for error detection but impacted workload.
Conclusions:
- The evidence base for monitoring strategies is limited, necessitating more prospective, comparative studies.
- Risk-based, targeted, and central monitoring approaches appear promising and efficient for clinical trials.
- Further research should focus on optimizing central monitoring with triggered on-site visits based on trial-specific risk assessments.
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