Real-world evidence (RWE) comprises information or analytical insights derived from real-world data (RWD) sourced from a variety and growing range of uncontrolled or dynamic settings (e.g., non-controlled trial settings). RWE policy is an area of study, research, and practice that concerns the development and implementation of strategies to incorporate RWE into important decision-making settings.

Real-world evidence (RWE) comprises information or analytical insights derived from real-world data...

The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the U.S. FDA, is co-convening the Rare Disease Innovation, Science, and Exploration (RISE) Workshop series with the Rare Disease Innovation Hub. With many rare diseases lacking approved therapies these patient populations face unique challenges to medical product development, including small patient populations,...

The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the U.S. FDA, is...

Duke-Margolis has explored how policy approaches can be steered to better address the burden of infectious diseases. In this project, viral respiratory infections were used as the primary case example because of their propensity for transmissions and widespread availability of vaccines, therapeutics, and diagnostics to manage disease.

Duke-Margolis has explored how policy approaches can be steered to better address the burden of...

Through this research project, Duke-Margolis, in partnership with a range of stakeholders and experts, will develop an evidence-based implementation plan for a national hepatitis C elimination strategy. This work will build on evidence from past and current implementation activities, particularly previous initiatives undertaken by Louisiana and other states, as well as by CDC, HRSA, and other...

Through this research project, Duke-Margolis, in partnership with a range of stakeholders and...

Reliable drug supply, Valuing availability, Advanced Manufacturing Technologies, and Patient-Center Focus (ReVAMP) The Consortium’s mission is to identify effective policy solutions that promote a resilient drug supply chain with advanced manufacturing capabilities and, ultimately, reduce the frequency and severity of drug shortages. Based on input from a wide range of experts involved in...

Reliable drug supply, Valuing availability, Advanced Manufacturing Technologies, and Patient-Center...

Duke-Margolis AI researchers are devoted to harnessing the potential of safe, trustworthy, and responsible AI to transform health care

Duke-Margolis AI researchers are devoted to harnessing the potential of safe, trustworthy, and...

FDA’s accelerated approval of aducanumab for the treatment of Alzheimer’s disease (AD) has added urgency to the discourse around evidence generation for this and other AD monoclonal antibodies (mAbs), treatment costs, and patient access to treatment. As more information is expected to flow from aducanumab’s phase 4 trial and pivotal trials of other anti-amyloid mAbs, important evidentiary gaps and...

FDA’s accelerated approval of aducanumab for the treatment of Alzheimer’s disease (AD) has added...

Combating the growing threat of antimicrobial resistance (AMR) requires generation of innovative antibiotics, but a low expected return on investment limits commercial development. Existing incentives have not adequately addressed the financial challenges developers encounter. Reviving investment and development in this space will require new approaches that create a sustainable market for...

Combating the growing threat of antimicrobial resistance (AMR) requires generation of innovative...

Duke-Margolis formed the Value for Medical Products Consortium (formerly the Value-Based Payment for Medical Products Consortium) in 2017 to address challenges to VBP arrangement implementation, including legal and regulatory barriers, and operational challenges to carrying out arrangements. Since its inception the Consortium has expanded its focus to include the advancement of VBPs and other...

Duke-Margolis formed the Value for Medical Products Consortium (formerly the Value-Based Payment for...

Duke-Margolis researchers are conducting a multi-part research project to better understand how health systems can effectively implement AI governance at their organizations.

Duke-Margolis researchers are conducting a multi-part research project to better understand how...

Alzheimer’s disease (AD) is a significant health burden for the elderly population, and is associated with more than 1.9 million annual deaths worldwide and more than $226 billion in direct healthcare costs in the U.S. With only five drugs currently on the market, there is an unmet medical need for patients. A number of innovative “early stage” AD therapies are currently under development that...

Alzheimer’s disease (AD) is a significant health burden for the elderly population, and is...