Predictive Quality Management in Retention, Adherence, and Regulatory Landscape of Digital Platforms in Parkinson’s Disease Clinical Trials: A Systematic Review, Meta-Analysis, and Comparative Policy Analysis

Abstract

Background: Digital health technologies, including mobile applications, wearable sensors, and telemedicine platforms, are progressively being incorporated into Parkinson's Disease clinical trials. While participant retention and adherence are important to ensure valid trial outcomes and accurate data, systematic evidence on performance metrics, platform characteristics, and regulatory frameworks remains fragmented.

Methods: We conducted a systematic literature review following PRISMA 2020 guidelines to assess retention and adherence rates, digital platform characteristics, the effects of trial design, and regulatory considerations for Parkinson’s Disease clinical trials using digital platforms. We used structured database queries (PubMed/MEDLINE, Embase, Scopus, Web of Science, Cochrane CENTRAL, etc.) for terms related to Parkinson’s Disease, digital platforms, retention/adherence, and regulatory evidence from inception through August 2026. We used eight predefined criteria to screen studies, with abstract and full-text screening thresholds. We extracted study design, platform type, retention rates, adherence measures, sample size, and readiness for meta-analysis.

Results: After deduplication of 1505 identified records, 1190 unique papers remained; 500 were screened at the abstract level, 41 advanced to full-text assessment, and 19 studies were included. Retention rates varied from 35% to 98%, depending on the platform type and follow-up duration. Telemedicine platforms achieved 91–98% retention, wearable sensors 69–92%, and smartphone applications 35–61% at 12 months. Adherence ranged from 50% to 95.7%. The study provided sufficient quantitative data for formal meta-analysis. None of the included studies specifically addressed regulatory frameworks or differences in jurisdictional policy.

Conclusion: Digital platforms exhibit variable but often acceptable retention and adherence in Parkinson's Disease clinical trials, with platform type, intervention intensity, and follow-up duration as key determinants. Telemedicine and passive wearable monitoring perform better than active smartphone testing. Standardised reporting of quantitative metrics and regulatory analysis remain limited, which hampers meta-analytic synthesis and the provision of cross-jurisdictional implementation guidance.