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Can Historical Control Group Data Be Used to Replace Concurrent Controls in Animal Studies?
Thomas Steger-Hartmann1, Matthew Clark2
1Bayer AG, Investigational Toxicology, Berlin, Germany.
Toxicologic Pathology
|October 31, 2023
Summary
High-quality animal safety data can create virtual control groups (VCGs) to reduce costs and ethical concerns. Careful assessment is needed to ensure VCGs maintain study sensitivity for detecting adverse events and safety thresholds.
Area of Science:
- Pharmacology and Toxicology
- Biostatistics
- Regulatory Science
Background:
- Large datasets of high-quality animal safety data are available from regulated studies.
- Classical applications include quality control and identifying treatment effects.
- The concept of re-using data for virtual control groups (VCGs) has emerged.
Purpose of the Study:
- To explore the potential of virtual control groups (VCGs) in animal safety studies.
- To address the challenges and ensure VCGs do not compromise study sensitivity.
- To propose a systematic approach for assessing the scientific value of replacing concurrent controls with VCGs.
Main Methods:
- Summarizing the current scientific discussion on VCGs.
- Proposing a framework for systematic assessment of VCGs.
- Evaluating the potential impact on study sensitivity and detection of safety signals.
Main Results:
- The ethical and cost-saving benefits of VCGs are significant.
- Potential challenges include maintaining study sensitivity to detect adverse events, safety thresholds, target organs, and biomarkers.
- A systematic assessment is crucial for validating the scientific value of VCGs.
Conclusions:
- Virtual control groups (VCGs) offer promising ethical and economic advantages in animal safety research.
- Rigorous evaluation is essential to ensure VCGs do not diminish the ability to detect critical safety information.
- A structured approach is proposed to assess the scientific validity of using historical data for VCGs.
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