Stephen Colvill, Thomas Roades, Gerrit Hamre, Marianne Hamilton Lopez, Cameron Joyce, Remi Shendell, and Mark McClellan co-authored a white paper, “Advancing Federal Coordination to Address Drug Shortages,” that mapped a path forward to address the challenges to the drug supply chain. The authors propose the establishment of a new Prevent Drug Shortages (PDS) Initiative with requisite authorities and funding to lead a cross-cutting effort to improve drug supply chain reliability. The paper was informed by work with the Duke-Margolis Drug Supply Chain Resilience and Advanced Manufacturing Consortium. 

Robert Califf, Commissioner of the U.S. Food and Drug Administration (FDA), shared this white paper on his social media page and encouraged others to read this “comprehensive approach” to addressing drug shortages.

Politico, Bloomberg, and STAT were among the media that covered the paper.

STAT's article, "6 ways the government could help address drug shortages, including in cancer," shared different approaches that could enhance federal efforts to combat drug shortages. They note that, while many government programs exist to mitigate drug shortages, the path forward is still unclear. "Most of the proposals are not comprehensive," Assistant Research Director Stephen Colvill told them.

Duke-Margolis submitted a comment letter to CMS regarding its recent buffer stock proposal, which aims to minimize drug shortages. The letter offers recommendations to make the proposal more cost-effective and references findings from the above white paper. Read more here.

The Coalition for Advancing Clinical Trials at the Point-of-Care (ACT@POC) published an open letter urging health systems to enact a culture that encourages point-of-care research and addresses challenges to it. Read the full letter here.

Read more here.

Duke’s Clinical Trials Transformation Initiative (CTTI) is leading an initiative to transform clinical trials and has just launched the Measuring Trials Transformation project. As part of this, CTTI has publicized ways of measuring progress in their efforts. These metrics aim to indicate whether they are making progress to improve trials by 2030. CTTI has opened a public comment period to view and comment on the draft measures it has developed. Submit your feedback here through October 20, 2023.

Duke-Margolis researchers Rachele Hendricks-Sturrup, Trevan Locke, Nora Emmott, Maryam Nafie, Matt D’Ambrosio, and Sandra Yankah published three white papers that explore methodologies for RWE evidence generation:

Improving Patient Subgroup Representation with Real-World Data: Describes opportunities for and challenges to leveraging RWD in order to estimate and measure treatment effects among and across patient subgroups. Studies using RWD/E can enable inclusion of traditionally underrepresented subgroups as there are fewer barriers to research participation than randomized clinical trials.

Harnessing the Potential of Real-World Evidence Master Protocols: Describes key characteristics of RWE master protocols and how they can support the development of critical evidentiary needs for medical products.

Lessons from Learning Health Care Systems and Recommendations for Successful Implementation: Explores the current status of RWD use in a subset of U.S. health systems with the aim of gaining a clear understanding of the current state of implementing learning health system enabled by RWD. Based on their findings, the authors provide recommendations pertaining to infrastructure development, supportive payment models, informed consent considerations, and workforce training needs.

Health Equity Policy & Primary Care Fellow Gaby Plasencia, former Policy Analyst Kamaria Kaalund, and Health Equity Faculty Director Andrea Thoumi, co-authored an editorial published in the American Journal of Public Health, “Training Latinx Community Health Workers as Clinical Research and Health Care System Navigators.” While community health workers can increase trust and engagement from marginalized populations, they often lack formal research training. The editorial discusses policy strategies to provide this essential training. Read the authors’ recommendations here.

Katie Huber, Will Bleser, Rebecca Whitaker, Karina Vasudeva, Jessye Halvorson, and Rob Saunders co-authored a new report in the Milbank Memorial Fund that describes lessons learned from North Carolina’s Healthy Opportunities Pilots (HOPs) program. The Pilots is the country’s most expansive Medicaid program to address health-related social needs related to food, housing, transportation, interpersonal safety, and toxic stress. The report provides recommendations on the design and implementation of the program, including how to engage with providers, sustain the work beyond the program’s funding, and leverage data and technology. Read more here.

Research Director Will Bleser comments in the Harvard Public Health article, “North Carolina’s radical Medicaid reinvention,” on HOPs and its promise to improve the lives of NC Medicaid enrollees. Read more here.

Duke-Margolis convened executive leaders from health systems, Medicaid and commercial payers, and the North Carolina Department of Health and Human Services to discuss strategic aims for advancing health care transformation in North Carolina. The group discussed several opportunities to make progress on NC State Transformation Collaborative (STC) priority areas, including reducing administrative burden through measure simplification, facilitating data sharing through improved interoperability, and increasing investments in behavioral health and the broader healthcare workforce. To keep up-to-date with the work of the STC, subscribe to their newsletter here.

CMS has set a bold vision to transition all Traditional Medicare beneficiaries into accountable care relationships by 2030. Achieving this goal will require strategic coordination and collaboration across stakeholders to create transformational change in providing high-quality, whole-person care to all Medicare beneficiaries. In partnership with West Health, Duke-Margolis will bring together CMS leadership, leading experts in public health and academic medicine, and innovators from the private sector to discuss a path forward in achieving the CMS strategic vision.

Learn more and register here.

Register here. 

15^th Annual Sentinel Initiative Public Workshop

This workshop is hosted under a cooperative agreement with the FDA and will provide an opportunity for attendees to discuss recent achievements and developments in the Sentinel Initiative. Participants will also hear from Sentinel Initiative leadership on a range of key issues including recent studies and applications of Sentinel to protect and promote public health during the COVID-19 pandemic. Additionally, sessions will consider key progress made to fulfill Prescription Drug User Fee Act (PDUFA) commitments, advance innovation within Sentinel, and to expand and extend important capabilities of the data network.

Learn more and register here.

Learn more and register here.

The digital marketing landscape is a dynamic and rapidly evolving ecosystem, and marketers have a growing array of communication channels to promote products to consumers. It is important to understand how current and emerging trends in digital marketing may impact information conveyed to various audiences in prescription drug promotional materials. This workshop, hosted under a cooperative agreement with the FDA, explored the state of digital prescription drug promotion, including the technologies and strategies currently available to and commonly used by marketers.

Learn more here.

Post-approval pregnancy safety studies (or studies that focus on medication use after approval) can provide useful information to guide safe use of medication during pregnancy. During this workshop, participants learned more about designs of post-approval pregnancy safety studies for drug and biological products regulated by the FDA’s Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research, and experiences with implementing these studies. Learn more here.

The FDA is still accepting comments regarding this workshop and the framework they are developing around post-approval pregnancy safety study data. To submit a comment, please follow this link and share your feedback before November 30, 2023.

Convened by the Duke-Margolis Real-World Evidence Collaborative, this public convening will provide a venue for reviewing recent Collaborative activities, real-world data (RWD) and real-world evidence (RWE) policy developments, and promising future applications of RWD/RWE. Discussion will focus on the role of master protocols for RWE, evaluating real-world efficacy in patient subgroups, and the generation of more practically relevant evidence by leveraging RWD.

Learn more here.

The application for 2024-2025 undergraduate Margolis Scholars opens on Monday, October 9! Margolis Scholars is a prestigious program for Duke University students who demonstrate a strong interest in and commitment to a career in health policy and management, as well as leadership potential to improve health policy. The Margolis Scholars program provides promising undergraduate and graduate/professional students with the necessary knowledge, skills, and abilities to be the next generation of health care leaders. Selected undergraduate Scholars are engaged in the program for 2 years. Applications will be accepted through Tuesday, November 7. Learn more here.

Duke-Margolis welcomes a new Core Faculty member: Kamal Golla, MD, MPH. Kamal is a faculty member in the Duke Department of Urology as well as the current Medical Director for Value Transformation at Evolent Health, and he has worked with Duke-Margolis in the past during his time as a Duke National Clinician Scholar. His interest in transforming the health care payment and delivery system has provided valuable insight on Duke-Margolis’ work with NC Medicaid, the State Transformation Collaborative, and the integration of specialty care models with accountable care organizations. In his Core Faculty role, Kamal will continue to advise and collaborate on projects in our Health Care Transformation portfolio.

Research Director Christina Silcox was quoted in the WebMD article, “Cost May Lead Many to Skip COVID Testing: Why That’s a Problem.” The article discusses the end of the public health emergency in May and how high COVID testing prices have affected public health. Christina notes that, “when you add cost to COVID exhaustion, you increase the incentive not to test at all.” Read more here.

Christina was a panelist at the “Health AI+” meeting hosted by the Consumer Technology Association and the AFDO-RAPS Healthcare Products Collaborative. The private event aimed to demystify artificial intelligence technology and discuss its uses and challenges in health, and brought together stakeholders from government, providers, and manufacturers.

Christina also spoke at Connected Health Initiative and Duke AI Health’s event, “Artificial Intelligence & the Future of Digital Healthcare.” Her panel covered a number of topics, including the bias, privacy, and generalizability of AI. She also discussed the potential for these new tools to improve clinicians’ workload and patients’ outcomes and experiences within the health system. Learn more here.

Core Faculty member Krishna Udayakumar co-authored an article in BMJ Global Health: “Comparing research and development, launch, and scale up timelines of 18 vaccines: lessons learnt from COVID-19 and implications for other infectious diseases.” The article discusses the global policy potential to accelerate timelines for vaccine manufacturing and increase access to vaccines in low-income and middle-income countries. Read it here.

Salon interviewed Krishna for the article, “COVID boosters are coming, yet many countries still can't access vaccines, causing preventable death,” and discussed the same issue of global vaccine manufacturing and distribution. Read Krishna’s thoughts on the topic here.

Assistant Research Director Stephen Colvill spoke at “Mitigating Drug Shortages,” a summit hosted by the American Cancer Society, American Cancer Society Cancer Action Network, and US Pharmacopeia. Stephen addressed the critical issue of cancer drug shortages and discussed ideas to improve access to these life-saving treatments and to prevent future shortages. Learn more about the event here.

Core Faculty member Don Taylor co-authored a paper, “Mission, Money, and Race: Creating Duke University’s Medical Enterprise, 1930-70,” to examine Duke’s history in treating patients and training physicians during segregation. The research concludes with suggestions about “how the Duke community can look back at the first Century of Duke’s Medical Enterprise in a way that helps us to imagine what we can achieve in the second Century of the University.” Read more here.

Core Faculty member Nathan Boucher received a grant from the National Center for Homelessness among Veterans. He and his research colleague from Boston VA Health System will work with Housing and Urban Development-Veterans Affairs Supportive Housing to analyze new VA health system survey data on older Veteran homelessness and conduct in-depth interviews and user-centered design sessions. The goal is to develop implementation blueprints to pilot for two large VA networks in Durham and Boston.

Emma Ladd is a Policy Research Assistant with the Biomedical Innovation team. She supports work related to the Drug Supply Chain Resilience and Advanced Manufacturing Consortium. Emma is a 2022 graduate of University of South Carolina, earning a Bachelor of Science in Biochemistry and Molecular Biology and in Economics before moving to Spain to teach English. During her undergraduate studies, Emma gained research experience with cardiac cell-therapies in a bioengineering lab and DNA replication and repair in a molecular biology lab. She looks forward to applying her interdisciplinary background to the health policy space.

Emily Proehl is a Policy Analyst with the Health Care Transformation team, where she will provide support to the work on North Carolina Medicaid’s value-based payment strategies. She holds a Master of Public Health in Health Policy from the UNC-Chapel Hill Gillings School of Global Public Health, specializing in maternal and reproductive policies. Before joining Duke-Margolis, Emily was a UNC research assistant and a Fellow for the Massachusetts Health Policy Commission, where she contributed to a wide range of projects encompassing social determinants of health research, maternal and newborn care initiatives, and health equity research. Emily earned her Bachelor of Arts in Political Science and a Bachelor of Public Health from the University of Florida.

Max Yates has joined Duke-Margolis as a Policy Analyst with the Health Care Transformation team, supporting the work on value-based payments models, North Carolina health transformation, and public health. Max recently graduated from the University of Cambridge with a Master of Philosophy in Population Health as a Marshall Scholar. He received his Bachelor of Science in Biochemistry at Montana State University and was a summer intern for the Medicaid and CHIP Payment and Access Commission (MACPAC). Before heading to the UK, Max lived in Sitka, Alaska, where he was a high school math teacher and guidance counselor as well as a volunteer firefighter.

Do you want to be part of health policy in action? Do you want to work on the leading health policy issues confronting cities, states, the nation, and the globe? The Duke-Margolis team is a dynamic, high impact national leader in leveraging policy to ensure high quality, affordable care for all. Multiple positions are currently available with new ones added frequently. Click here to view all of our career opportunities.