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Drug-device trials for infectious diseases: CDRH perspective
Kristen L Meier1, Steven Gitterman
1Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Silver Spring, MD 20993-0002, USA. kristen.meier@fda.hhs.gov
Summary
Evaluating new infectious disease diagnostic tests requires clinical trials that assess both diagnostic and therapeutic components. This approach is crucial for non-microbiologically based assays, ensuring safety and effectiveness.
Area of Science:
- Infectious disease diagnostics
- Clinical trial design
- Medical device evaluation
Background:
- Traditional infectious disease diagnostic test assessment relies on comparison with reference standards like culture.
- Non-microbiologically based assays present unique challenges for performance evaluation.
- Simultaneous evaluation of diagnostic and therapeutic components in clinical trials is often overlooked.
Purpose of the Study:
- To propose that clinical trial designs incorporating both diagnostic and therapeutic elements are necessary for evaluating non-microbiologically based assays.
- To emphasize the utility of the test/marker-stratified design for such evaluations.
- To discuss general design challenges in trials that combine diagnostic and therapeutic components for infectious diseases.
Main Methods:
- Review and conceptualization of clinical trial designs for infectious disease diagnostics.
- Focus on test/marker-stratified designs.
- Discussion of challenges in trials evaluating both diagnostic devices and therapeutic drugs concurrently.
Main Results:
- The study suggests a shift from traditional reference standard comparisons to integrated diagnostic-therapeutic trial designs.
- The test/marker-stratified design is highlighted as a potentially valuable approach.
- Key challenges in simultaneously evaluating diagnostic and therapeutic interventions are identified.
Conclusions:
- Clinical trial designs integrating diagnostic and therapeutic components are essential for assessing novel non-microbiologically based infectious disease assays.
- The test/marker-stratified design offers a structured framework for such complex trials.
- Addressing design challenges is critical for robust evaluation of combined diagnostic and therapeutic strategies.
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