Mobile Phlebotomy in MASLD / MASH Clinical Trials: Enhancing Recruitment, Retention, and Data Integrity

Résumé fourni par la source

Background: Metabolic dysfunction-associated steatotic liver disease (MASLD, formerly NAFLD) and metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH) represents a growing global health burden, affecting an estimated 25-30% of adults worldwide. Despite high prevalence, no pharmacologic therapies have yet received regulatory approval. Clinical development programs in MASLD/MASH are challenged by complex eligibility criteria, reliance on biomarker-driven endpoints, and substantial participant burden, resulting in high screen-failure and attrition rates. Decentralized trial approaches, including home-based blood collection via mobile phlebotomy, have been proposed as mechanisms to improve trial accessibility and efficiency. Methods: This article is a narrative review with applied operational modeling. We synthesize peer-reviewed literature, regulatory guidance (including FDA guidance on decentralized clinical trials, Good Clinical Practice, HIPAA, and CLIA/CAP standards), and published evaluations of home-based phlebotomy in clinical research. Operational considerations, equity implications, and quantitative enrollment and retention modeling were examined. Results: Incorporation of mobile phlebotomy into clinical trial workflows has been associated with reduced logistical barriers to participation and improved retention. Decentralized trials have reported enrollment timelines up to 50% faster than traditional site-centric models and retention rates approaching 96% compared with approximately 70% in conventional designs. Applied modeling demonstrates that increasing retention from 70% to 85% can reduce required enrollment by approximately 17% to achieve the same number of completed participants. Evidence indicates that, when standardized protocols are followed, home-collected biospecimens meet laboratory quality benchmarks, preserving biomarker integrity critical to MASLD/MASH endpoints. Conclusions: Mobile phlebotomy offers a patient-centered, operationally scalable adjunct to site-based trial models in MASLD/MASH research. When implemented with appropriate oversight, training, and documentation, it aligns with contemporary regulatory expectations for decentralized trial elements. While not a replacement for all in-clinic procedures, mobile phlebotomy can meaningfully improve recruitment efficiency, retention, and data completeness in hepatology trials.

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