Adopting Clinical Trial Best practices of Hybrid Decentralized and Risk Based Quality Management (RBQM), to Help Optimize Prospective Observational (Real-World Evidence) Studies in Compliance, Cost and Time Criteria

OBJECTIVES: RWE contribution in FDA approvals has increased by 70% from 2019 to 2020. RWE continues to offer evidence demonstrating safety and/or effectiveness in growing number of regulatory decisions¹. During 2020, about 100% of FDA approvals in infectious and 75 % in Oncology disease area utilized RWE along with trial evidence². The industry is expected to enhance focus on prospective real world evidence studies to generate safety and/or effectiveness to support trial evidence.

METHODS: Industry needs to leverage following clinical trial best practices to optimize efficiency, cost, time, and compliance of prospective RWE studies.

• Hybrid & Virtual Decentralized Clinical Trials: During Covid-19, clinical trials were suspended. However, adoption of technology solutions like remote monitoring, e-enrolment, e-consent, e-CoA, home nursing, direct to patient shipments and cloud-based AI/ML based solutions enabled continuation of the trials³.
• Risk Based Quality Management (RBQM) and Predictive Analytics of Trials: Risk based monitoring strategies have been implemented to minimize site visits and enable targeted visits. This is aided by International Council of Harmonization (ICH) E6 (R2) guidance & FDA regulations, which focus on sponsor’s responsibility to establish a risk-based quality management approach for ensuring compliance to GCP. Risk monitoring platforms generate trial performance data visualizations. Predictive analytics forecast risk and generate preemptive action to optimize trial.

CONCLUSIONS: The prospective RWE studies have complexities of sample size (>10,000), sensitized data collection process, site visits, planning, monitoring, and high cost. These complexities can be reduced by adopting RBQM and patient centric hybrid & virtual decentralized approaches, which are proven in clinical trials.