RWE Conference Draws more than 1500 participants

Informal comment period to extend to October 11th 

Duke-Margolis convened a workshop on September 13 ^th to discuss the use of real-world data (RWD) and evidence (RWE) in drug development and regulatory decision-making. In advance of this workshop, the Center published a white paper that outlines considerations stakeholders should make when exploring the potential for regulatory use of RWE.

RWD, data relating to patient health status and/or the delivery of health care that is routinely collected from a variety of sources, and RWE, evidence derived from that data through the application of research methods, have the potential to be applied within a regulatory decision-making framework. However, progress has been limited by both an imprecise characterization of the kinds of RWD and RWE that could be useful and a clear assessment of how they can be applied in specific regulatory contexts.

The workshop, supported by a cooperative agreement with the U.S. Food and Drug Administration, explored the considerations that should guide the development of RWE that is fit for regulatory purposes and high priority opportunities to improve its development and use. Topics included an update on FDA’s implementation of the 21 ^st Century Cures Act’s provisions related to RWE and panel discussions focused on opportunities to improve the data development activities, study designs, and analytical methods used to create robust RWE that supports specific regulatory decisions.

View the webcast and review presentation slides on the event page.

DGHI Women's Health Symposium

Advancing Women’s Health in a Changing Political Environment

Friday, October 20, 2017

Great Hall, Trent Semans Center for Health Education

More Information

Recent News

Combining Medicaid Expansion with Managed Care Reform in North Carolina

Analysis explores how a non-expansion state like NC could combine ideas from both parties to achieve mutual goals

Medicaid expansion, combined with managed care reform, could increase the number of the insured North Carolinians living in rural areas, help providers succeed in population-based payment models, and improve health needs of the uninsured, according to a new report prepared by experts at the Duke-Margolis Center for Health Policy with funding from the Robert Wood Johnson Foundation. The analysis finds that pairing expansion with reform could help to improve health and avoid future spending on related illnesses. Read More

Medicare innovation can spur the next round of payment reform

"Since its creation in the Affordable Care Act, the Center for Medicare and Medicaid Innovation has led efforts at CMS to advance alternatives to fee-for-service. Working with CMS, and with states and employers, Medicare Advantage plans, Medicaid managed care plans, and commercial insurance plans are implementing new payment models that in many cases represent more fundamental reforms than Medicare has yet undertaken," write Duke-Margolis director Mark McClellan and Mike Leavitt of Leavitt Partners.

Read more in STAT First Opinion.

Together Duke Initiatives: Research Support

In efforts to invest in the Duke faculty as scholars and leaders of the university’s intellectual communities, and to provide new resources to support the faculty and their work, the Provost is pleased to offer the following opportunities for faculty and student support as part of Together Duke.

Intellectual Community Planning Grants

The Provost’s Office is offering support to Duke faculty who are interested in convening a group of colleagues to begin or test a new collaboration around a shared intellectual interest.

Provost’s Pilot Research Grants

The Provost’s Pilot Research Grants (PPRGs) support innovative research in the humanities and social sciences — across and between all disciplines — with the potential to have broad and sustained impact.

Collaboratories

Together Duke has targeted three challenges that reflect societal relevance, internal capacities for reflection and action, and alignment with Duke’s strategic priorities: Energy and Water Resources; Race, Religion, and Citizenship; and Population Health. Duke has the intellectual resources and organizational nimbleness to convene technical, legal, scientific, ethical, cultural and historical explorations of these issues. By drawing on disciplinary depth, interdisciplinary strengths, and commitment to engagement, we have the capacity to make crucial research contributions in these vital areas and to serve as an important node for convening stakeholders.

Learn more

Awards, Honors and Presentations

Gillian Sanders Schmidler will receive The John M. Eisenberg Award for Practical Application of Medical Decision Making Research from the Society for Medical Decision Making in October. This award recognizes an individual or organization that has demonstrated sustained leadership in translating medical decision making research into practice, and that has taken exceptional steps to communicate the principles and/or substantive findings of medical decision making research to policy makers, to clinical decision makers, and to the general public.

Mark McClellan, MD, PhD, presented the Accountable Care Atlas at the Accountable Care Learning Collaborative on October 5. The Accountable Care Atlas is a public resource intended to help the provider community identify and prioritize the care delivery competencies necessary for success under risk-based payment.

Gregory Daniel, PhD, MPH, was an invited speaker at the DRIVE-AB Conference in Brussels, Belgium in September. In addition, Dr. Daniel was an invited speaker at the MedTech Conference and CBI's Real World Evidence Conference. He also gave an invited talk on value-based payment at Specialty Drug Management Innovations for Health Plans last week.

Charlene Wong, MD, MSPH, presented a policy talk to the Duke internal medicine & pediatrics residents on Sept 27 ^th , entitled “Looking forwards & backwards: Impact of health policy on adolescents and young adults.” She also had an article come out in Hospital Pediatrics: “Pediatric price transparency: Still opaque with opportunities for improvement”

Submissions Welcome!

Interesting Project? Funding Opportunities? News and Events? Awards and Honors? 

Policy Impact? Op Eds? 

We're looking for ways to highlight your accomplishments and share information.

Email submissions to dukemargolis@duke.edu.