Remote Cardiac Safety Monitoring through the Lens of the FDA Biomarker Qualification Evidentiary Criteria Framework: A Case Study Analysis

Digital Biomarkers

Daniel Bloomfield¹  John A. Wagner²  Steven C. Hoffmann³  Joseph P. Menetski³  Vadim Zipunnikov⁴  Elena S. Izmailova⁵  William A. Wood⁶  Qi Liu⁷  Jason Homsy⁸ 

[1] Anthos Therapeutics, Cambridge, MA, USA;Cygnal Therapeutics, Cambridge, MA, USA;Foundation for the National Institutes of Health (NIH), North Bethesda, MD, USA;Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA;Koneksa Health, New York, NY, USA;Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA;Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, MD, USA;Takeda Pharmaceuticals International, Cambridge, MA, USA;

关键词: digital health;    cardiac;    remote monitoring;    biomarkers;    sensors;    evidentiary criteria;   

DOI  :  10.1159/000515110

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown