FEBRUARY 2024LIFE SCIENCES REVIEW8RWE and DigitalGiven the prevalence of many diseases with low adherence to treatments and therapies, real-world evidence(RWE) and digital innovations that are beyond randomized controlled trials (RCTs) can help provide timely and actionable insights. RWE can be critical co morbid conditions as risk factors for corona virus disease 2019 (COVID-19). RWE, digital innovation and artificial intelligence (AI) are useful for patient-centricity, medicines regulation, and sophisticated algorithms based on machine learning (ML) and deep learning (DL). It is important to harness real-world data (RWD) for regulatory purposes, via quality and accessibility, and under data privacy regulations. For medical, RWE can help enable partnerships with government agencies making authorization and treatment guidelines decisions, deliver enriched content for medical education, and provide critical insights to key opinion leaders. For regulatory, on the other hand, RWE can help prioritize product registration process, support regulatory authorities' data queries, and provide insights for label expansion. For commercial, RWE can provide information to support pricing and reimbursement decisions by payors, support business strategies and business development plans, enable commercial and due diligence assessments, make growth plans for informed decision-making, and deliver insights for market access.By Kelly H. Zou, PhD, PStat®, FASA,Head, Global Medical Analytics, Real World Evidence, and Health Economics & Outcomes Research, Viatris Inc.IMPACT OF REAL-WORLD EVIDENCE AND DIGITAL INNOVATION IN HEALTHCAREIN MY OPINIONKelly H. Zou
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