Standard of care (SoC) plays a critical role in healthcare and research, acting as a benchmark for what is widely accepted as appropriate medical treatment or practice in a given context. It is shaped by clinical guidelines, expert consensus, and evidence-based practices. However, its application is not static; it evolves based on emerging evidence, technological… Continue reading Understanding Standard of Care and its Role in RWE Research
Category: Real World Evidence
Digital Twins in Healthcare: Unlocking Potential and Overcoming Challenges
The concept of digital twins has gained significant attention in recent years, revolutionizing industries such as manufacturing, urban planning, and increasingly, and healthcare. A digital twin is a virtual replica of a physical object, system, or process, enabling real-time monitoring, simulation, and analysis. By creating a digital version of something in the real world, industries… Continue reading Digital Twins in Healthcare: Unlocking Potential and Overcoming Challenges
Predictive and Prognostic Biomarkers in Clinical Research: A Key to Advancing Precision Medicine and Personalized Treatments
The vast amount of molecular biological data available through genomic databases serves as a valuable resource for the discovery and analysis of biomarkers. Biomarkers are essential to the advancement of personalized medicine, as they enable the identification of patient subgroups within a disease population who may respond differently to specific treatments. By leveraging genomic data… Continue reading Predictive and Prognostic Biomarkers in Clinical Research: A Key to Advancing Precision Medicine and Personalized Treatments
Integrated Evidence Generation Strategy for Rare Disease: A Comprehensive Approach Across Clinical Phases
Developing an integrated evidence generation strategy for a rare disease requires careful planning, cross-disciplinary collaboration, and adherence to regulatory guidelines. The strategy should be holistic, incorporating real-world evidence (RWE), clinical trials, and patient-centric data to address the unique challenges associated with rare diseases and to support regulatory approvals, market access, and ongoing patient care. … Continue reading Integrated Evidence Generation Strategy for Rare Disease: A Comprehensive Approach Across Clinical Phases
Fit-for-Purpose in RWE: Comparing Regulatory Approaches Across Global Agencies
The concept of “fitness-for-purpose” (or fit-for-purpose) is a key definition in regulatory science, as it determines whether the data, methods, or tools used in a study are suitable for their intended purpose. In particular, “fit-for-purpose” in Real-World Evidence (RWE) research refers to the suitability of the data and study design for addressing a study design… Continue reading Fit-for-Purpose in RWE: Comparing Regulatory Approaches Across Global Agencies