Researchers from Duke-Margolis and DCRI received two of three grants awarded by the
PhRMA Foundation
for work impacting the development of new value-based care models in the United States.
Value Assessment Research awardees at Duke include
Shelby D. Reed, PhD
, of the Duke Clinical Research Institute and
Gillian Sanders Schmidler, PhD, of Duke-Margolis. The grants of $100,000 over one year will enable two projects focused on value and cost-effectiveness in health care.
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Duke University’s Fuqua School of Business has expanded its healthcare offerings with a 19-month online master in quantitative management degree in health analytics. The program curriculum will combine business, analytics, and health sector institutional training. Fuqua and the Duke-Margolis have been in active discussions about this new, innovative program and look forward to working together in the future.
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The Duke-Margolis Center for Health Policy, funded by the
Gordon and Betty Moore Foundation, is launching an initiative to investigate how accountable care approaches can improve care for people with serious illnesses, which is a next step in the Center’s work on accountable care. In partnership with
Leavitt Partners, the project will identify promising practices and practical operational guidance that organizations could implement.
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Policies to improve global public health generally focus on delivering population health improvement through medical services – whether preventive, acute, or rehabilitative. Yet there is increasing evidence that policies that cross economic sectors, such as transportation, agriculture, or energy, can have a large impact on public health by reducing disease and injury.
Given the kaleidoscope of possibilities, governments and policymakers need to understand which of these “inter-sectoral” policies are most effective for improving global public health. A new study by a team of ten researchers, including
Gavin Yamey, MD, MA
, director of the
Center for Policy Impact in Global Health
at the
Duke Global Health Institute
, examined the available evidence and proposes a package of 29 inter-sectoral policies that could be implemented by all low- and middle-income countries to improve public health.
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Duke-Margolis Center for Health Policy is pleased to offer a
Bass Connections
project for the 2018-2019 academic year: Transforming Alzheimer's Disease Care Through Integrating Caregivers.
Bass Connections is a university-wide initiative that brings students and faculty together to tackle complex societal challenges. Working in interdisciplinary research teams, students at all levels collaborate with faculty, postdocs, and outside experts to conduct cutting-edge research. Students gain greater exposure to inquiry across the disciplines, partner with unlikely fellow thinkers, and receive sustained mentorship in an ambitious team-based environment.
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In the U.S., the FDA plays a key role in tobacco control and prevention. In July 2017, the agency announced a new, comprehensive regulatory plan and framework aimed at further reducing tobacco-related disease and death in the U.S. The underlying philosophy of this new approach is the recognition that nicotine-containing products fall along a spectrum of risk, with combustible cigarettes being the most harmful way of satisfying a craving for nicotine. In contrast, medicinal nicotine replacement therapies (NRTs), such as skin patches, gum, and lozenges, are considered safe enough to be sold over the counter (OTC) as smoking cessation aids. Despite their OTC status, however, they are still less widely available than the most harmful products on the market – cigarettes. FDA aims to change that dynamic, and to that end recently announced the formation of a Nicotine Steering Committee to evaluate and modernize FDA’s approach to the development and regulation of medicinal nicotine.
On December 12, 2017, the Duke-Margolis Center for Health Policy convened a public workshop to discuss the role of medicinal nicotine in addressing the tobacco epidemic as well as the key policy issues that FDA will need to address as part of their broader efforts. The event featured a keynote address by FDA Commissioner Scott Gottlieb followed by a panel discussion which included Mitch Zeller, the Director of FDA’s Center for Tobacco Products, along with key leaders from the public health, addiction, and advocacy community. Several key themes emerged from the discussion, including the need to encourage new product development and innovation, as well as the importance of making existing products more effective through evidence-based labeling changes, improved communication to the public, and more effective support for patients trying to quit.
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Greg Daniel, PhD, RPH
,
will be a panelist on the Plenary Market Access Panel at Phacilitate Cell & Gene Therapy World 2018 Conference on January 22.
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DCRI Research Forum: Real World Evidence for Regulatory Decisions
January 30, 2018 - 12:00-1:00 pm
Gillian Sanders Schmidler, PhD
Gregory Daniel, PhD, MPH
You can attend in-person in the DCRI North Pavilion Lower Lecture Hall (2400 Pratt Street, Durham, NC 27705) or via our live broadcast available at
DCRI.org/research-forum
. You can also join the conversation on social media:
#DCRIResearchForum
*Please note that CME credit text information will now be provided on the opening slides within each DCRI Research Forum presentation. Contact
Jennifer Gloc
with any questions.
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February 5, 2018 - 9:00 am to 4:30 pm
Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this public event will bring together multi-disciplinary experts to explore and discuss approaches for addressing key challenges related to the evaluations of cancer products in the presence of non-proportional hazards. Discussion will encompass the development and application of innovative oncology clinical trial designs, alternative statistical methods for evaluating treatment effects of time-to-event endpoints, and potential outcome measures that more accurately capture treatment effect.
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February 7, 2018 - 9:00 am
1 Bethesda Metro Center
Bethesda, MD 20814
This annual workshop serves as a forum to bring together leading experts and interested stakeholders to discuss the ongoing development of the Sentinel Initiative. The Food and Drug Administration Amendments Act of 2007 authorized the Sentinel Initiative with the charge of utilizing electronic health care data for post market risk identification and analysis of medical product safety.
Learn More and Register
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February 15, 2018 - 9:00 am to 4:15 pm
The current opioid epidemic remains a major public health crisis. In response to growing rates of opioid misuse, addiction, and overdose, stakeholders across the U.S. healthcare system are working to implement strategies designed to ensure that opioids are safely and appropriately prescribed. As policymakers, health systems, and insurers move quickly to adopt prescribing guidelines and other interventions, assessing the impact of these strategies on opioid use, patient health outcomes, and public health is critical to implementing these strategies effectively.
This public workshop brings together top experts and speakers to examine the landscape of strategies and tools being used to support safe opioid prescribing, how data and health IT can advance these efforts, and how stakeholders are addressing barriers to implementation and potential unintended consequences. Topics will include how we define and measure success and how we support health systems and payers in finding evidence for what really works.
Speakers include Scott Gottlieb, U.S. Food and Drug Administration; Judy Staffa, U.S. Food and Drug Administration; Larry Greenblatt, Duke University School of Medicine; Regina LaBelle, Duke-Margolis Center for Health Policy; Gregory Daniel, Duke-Margolis Center for Health Policy; Mark McClellan, Duke-Margolis Center for Health Policy.
Learn More and Register
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This public workshop, convened under a cooperative agreement with the Food and Drug Administration, is being held in response to public comments received on the draft guidance “
Safety Assessment for IND Safety Reporting” issued in December 2015 requesting a public meeting to discuss the draft guidance and its implications. Broadly, this workshop will provide an opportunity for the stakeholder community to continue discussions around key challenges related to IND reporting practices proposed in the guidance. Sessions will highlight industry experience implementing these approaches, and discussion topics will include but not limited to safety assessment and aggregate analysis, as well as potential best practices for unblinding of data and trial integrity, identifying expected/anticipated events, and determining reporting thresholds.
Learn More and Register
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The Duke-Margolis Center for Health Policy's mission is to improve health and the value of health care by developing and implementing evidence-based policy solutions locally, nationally, and globally.
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This newsletter is published monthly by the Robert J. Margolis, MD, Center for Health Policy at Duke University.
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