Key result
Remote cardiac safety monitoring requires context-specific clinical validation and new statistical methods for data interpretation.
Why the study?
Cardiovascular safety liabilities are often not detected in early-stage clinical trials and become apparent only after chronic drug administration, highlighting the need for improved remote cardiac safety monitoring methods.
Remote cardiac safety monitoring in drug development requires rigorous analytical and clinical validation, emphasizing the need for new statistical methods to interpret large amounts of ambulatory data.
Supports validation of remote monitors before cardiac safety use in trials; leaves open standardized statistical methods for ambulatory data.
Clinical safety findings remain one of the reasons for attrition of drug candidates during clinical development. Cardiovascular liabilities are not consistently detected in early-stage clinical trials and often become apparent when drugs are administered chronically for extended periods of time. Vital sign data collection outside of the clinic offers an opportunity for deeper physiological characterization of drug candidates and earlier safety signal detection. A working group representing expertise from biopharmaceutical and technology sectors, US Food and Drug Administration (FDA) public-private partnerships, academia, and regulators discussed and presented a remote cardiac monitoring case study at the FNIH Biomarkers Consortium Remote Digital Monitoring for Medical Product Development workshop to examine applicability of the biomarker qualification evidentiary framework by the FDA. This use case examined the components of the framework, including the statement of need, the context of use, the state of the evidence, and the benefit/risk profile. Examination of results from 2 clinical trials deploying 510(k)-cleared devices for remote cardiac data collection demonstrated the need for analytical and clinical validity irrespectively of the regulatory status of a device of interest, emphasizing the importance of data collection method assessment in the context of intended use. Additionally, collection of large amounts of ambulatory data also highlighted the need for new statistical methods and contextual information to enable data interpretation. A wider adoption of this approach for drug development purposes will require collaborations across industry, academia, and regulatory agencies to establish methodologies and supportive data sets to enable data interpretation and decision-making.
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Izmailova et al. (2021) reported a review. Remote cardiac safety monitoring was evaluated. Remote cardiac safety monitoring using 510(k)-cleared devices requires analytical and clinical validity assessment in the context of intended use, alongside new statistical methods for data interpretation.
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