Mark McClellan

The potential for artificial intelligence to transform healthcare: perspectives from international health leaders

npj Digital Medicine · 2024-04-09 · 105 citations

Artificial intelligence (AI) has the potential to transform care delivery by improving health outcomes, patient safety, and the affordability and accessibility of high-quality care. AI will be critical to building an infrastructure capable of caring for an increasingly aging population, utilizing an ever-increasing knowledge of disease and options for precision treatments, and combatting workforce shortages and burnout of medical professionals. However, we are not currently on track to create th…

National coronavirus response: A road map to reopening

AEI Paper & Studies · 2020 · 70 citations

Understanding Use of Real‐World Data and Real‐World Evidence to Support Regulatory Decisions on Medical Product Effectiveness

Clinical Pharmacology & Therapeutics · 2021 · 57 citations

RWE has potential to provide efficient and relevant information on the effectiveness of medical products, complementing the data generated in clinical trials; however, how RWE can support regulatory decision-making is unclear, potentially limiting its use. The objective of this study was to identify and characterize instances where RWE was included in the evidence package to support the effectiveness of a medical product regulated by U.S. Food and Drug Administration. A retrospective landscape a…

A Brief Report on Proposed Areas of International Harmonization of Real‐World Evidence Relevance, Reliability and Quality Standards Among Medical Product Regulators

Pharmacoepidemiology and Drug Safety · 2025-03-01 · 12 citations

BACKGROUND: International harmonization of real-world data and evidence (RWD/E) standards is a goal among real-world data/real-world evidence (RWD/E) policy stakeholders. The Duke-Robert J. Margolis Institute for Health Policy developed an online 'International Harmonization of RWE Standards Dashboard' to provide timely updates around these goals. METHODS: Guidance for industry (draft and final) and related literature available online by medical product regulators globally was sought and, where…

Advancing the future of equitable access to health care: recommendations from international health care leaders

Health Affairs Scholar · 2024-08-01 · 11 citations

Abstract Disparities in access to health care are persistent and contribute to poor health outcomes for many populations around the world. Barriers to access are often similar across countries, despite differences in how health systems are structured. Health care leaders can work to address these barriers through bold, evidence-based actions. The Future of Health (FOH), an international community of senior health leaders, collaborated with the Duke-Margolis Institute for Health Policy to identif…