The BioGuard Framework: Setting New Standards for Digital Biomarker Use in Clinical Trials

Abstract ID 128908 Poster Board 406 Focus Area: Clinical Pharmacology, Clinical Trials Background: Clinical trials globally struggle with a mere 10% success rate. Integrating digital biomarkers from wearables, smartphones, and AI into clinical research promises to boost precision and efficiency, particularly in neurology, oncology, and cardiovascular research. This study evaluates their impact on trial efficiency, outlines integration challenges, and presents the BioGuard Framework as a holistic solution. Objective: This paper explores the role of digital biomarkers in clinical research, emphasizing their ability to overcome recruitment, engagement, safety monitoring, and data collection challenges. It also addresses barriers to adoption, including but not limited to ethical concerns, trial design challenges, data security and regulatory compliance, by introducing the BioGuard Framework. Methods: A literature review across neurology, oncology, and cardiovascular fields assessed digital biomarkers' effects and limitations, with significant attention to the Apple Heart Study and AI-based cognitive health analysis. The BioGuard Framework, devised from this review, aims for secure, ethical, and inclusive digital biomarker integration. Key Pillars of BioGuard: Advanced Data Security: Proposes AES-256 encryption and Zero-Knowledge Proofs for top data security. Regulatory and Compliance Strategy: Recommends development of a council to standardize digital biomarker guidelines. Interoperability and Standardization: Promotes standardization to facilitate interoperability among digital biomarkers technologies. Digital-biomarker Enabled Adaptive Trial Design: Champions the incorporation of digital biomarkers for flexible, data-driven protocol adjustments in clinical trials, enhancing trial efficiency and responsiveness. Hybrid Trial Models: Combines digital and conventional biomarkers for improved trial outcomes. Accessibility and Inclusivity: Makes digital biomarker-enabled tools globally accessible, increasing trial diversity. AI Fairness and Ethics: Encourages the adoption of fairness indicators and diverse datasets to minimize AI-bias Patient Data Autonomy: Emphasizes transparent data policies and informed consent. Ethical Use of Digital Data: Establishes ethical data handling guidelines. Trial Scalability and Agility Results: This study highlights digital biomarkers' potential to enhance clinical trial operations in neurology, oncology, and cardiovascular research. The BioGuard Framework, designed to address data security, compliance, inclusivity, and ethics, proposes a novel approach for digital biomarker integration. Its effectiveness and impact on trial operations will be evaluated in the next phase of the study through practical application in clinical trials. Conclusion: The BioGuard Framework offers a strategic advancement for incorporating digital biomarkers into clinical research, aiming to resolve operational challenges. Pending its application and evaluation in clinical trials, the framework is expected to foster a more secure, inclusive, and efficient research environment, marking a significant step towards optimizing clinical trial operations. Conflict of Interest Statement: None to declare.