“Integration of Real-World Evidence in Drug Evaluation”
The use of real-world evidence (RWE) is increasingly influencing clinical and regulatory decisions in the Europe Scleroderma Therapeutics market. Real-world data, derived from electronic health records, observational studies, and patient registries, provides critical insights into long-term treatment outcomes and safety profiles outside the controlled environment of clinical trials. Regulatory agencies in countries like Japan and South Korea are actively promoting the integration of patient-reported outcomes and RWE into therapeutic assessments to accelerate drug approval timelines, especially for rare and autoimmune conditions. These initiatives are enabling more accurate benefit-risk evaluations and paving the way for conditional approvals of novel biologics for scleroderma treatment.
