FDA Guideline: Real-World Data Sources: Claims, EHR, Registries & Digital Health Data
KPIs to track RWD asset utilisation and ROI for RWE programs
KPI Tracking for Real-World Data Asset Utilization and ROI in RWE Programs In the evolving landscape of healthcare, the importance of real-world data (RWD) and real-world evidence (RWE) is undeniable. Regulatory, biostatistics, and data standards professionals in pharma and medtech sectors must equip themselves with the knowledge to monitor and evaluate the effectiveness of their RWD assets. This comprehensive guide outlines the critical Key Performance Indicators (KPIs) necessary for tracking the utilization of RWD assets and determining the return on investment (ROI) for RWE programs. We will focus on key data sources such as claims data, electronic health records (EHR),…
Architectures for integrating digital health data into RWE pipelines
Architectures for Integrating Digital Health Data into RWE Pipelines As healthcare systems evolve, the integration of digital health data into Real-World Evidence (RWE) pipelines has become pivotal for regulatory, biostatistics, health economics and outcomes research (HEOR), and data standards professionals. This comprehensive guide provides a step-by-step approach to understanding the frameworks and regulatory implications of using real-world data (RWD) sources such as claims, Electronic Health Records (EHR), patient registries, and digital health information. Understanding Real-World Evidence (RWE) and Real-World Data (RWD) Real-World Evidence (RWE) represents the clinical evidence derived from the analysis of Real-World Data (RWD) relating to patient health…
Assessing fitness for purpose of RWD sources for specific RWE questions
Assessing fitness for purpose of RWD sources for specific RWE questions Assessing Fitness for Purpose of RWD Sources for Specific RWE Questions Real-world evidence (RWE) plays a critical role in shaping regulatory decisions, supporting health economics outcomes research (HEOR), and informing clinical practices. The assessment of real-world data (RWD) sources—such as claims data, electronic health records (EHR), patient registries, and digital health data—is pivotal in ensuring they are fit for the specific questions posed by RWE research. This article provides a comprehensive guide for regulatory, biostatistics, HEOR, RWE, and data standards professionals in the pharma and medtech sectors, focusing on…
Building internal RWD lakes and federated data networks for RWE
Introduction to Real-World Data (RWD) and Real-World Evidence (RWE) The evolving landscape of healthcare, characterized by an increasing demand for effective, cost-efficient treatments, has positioned Real-World Data (RWD) and Real-World Evidence (RWE) at the forefront of medical research and regulatory review. RWD refers to data collected outside the controlled environment of traditional clinical trials, encompassing various forms such as electronic health records (EHR), claims data, patient registries, and wearable device data. RWE, meanwhile, reflects the clinical and economic outcomes derived from analyzing this data, providing valuable insights into a product’s performance in a real-world setting. In the context of regulatory…
Governance and contracts for long term access to key RWD assets
Governance and contracts for long term access to key RWD assets Governance and Contracts for Long Term Access to Key RWD Assets As the utilization of Real-World Data (RWD) continues to expand within the pharmaceutical and medical technology sectors, understanding the governance and contractual frameworks for obtaining and maintaining long-term access to critical RWD assets is essential. This comprehensive tutorial will provide regulatory professionals, biostatisticians, health economics and outcomes research (HEOR) specialists, and data standards experts with a step-by-step guide to navigating the complexities of real world data sources including claims, Electronic Health Records (EHR), patient registries, and digital health…