New Research

New Evidence Approach Recommended to Evaluate Medical Product Effectiveness 

I ncluding real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making could improve the evaluation of the effectiveness of drugs in the marketplace, according to a new Duke-Margolis white   paper . In it, Duke-Margolis discusses how submissions reviewed by the Food and Drug Administration (FDA) can benefit from including RWE in evidence packages to support labeling changes regarding a product’s effectiveness through a totality of evidence approach. The paper reflects the input of the nearly 40 members of the Duke Margolis RWE  Collaborative . Duke-Margolis Center Director Mark McClellan moderated a   webinar  with experts to discuss the white paper, and what’s next for real-world data and evidence.

News

Trust, But Verify: Informational Challenges Surrounding AI-Enabled Clinical Decision Software

With the explosion of health AI technology comes an urgent need to better understand how to effectively communicate information about these tools in order to harness benefits and mitigate risks. Clinical decision software enabled by AI represents a particularly important area of focus. Information around appropriate use, benefits, and risks is potentially more complicated to determine and/or disclose for AI-enabled clinical decision software than for traditional medical devices. To explore these issues and more, the Center for Innovation Policy at Duke Law and the Duke-Margolis held a public meeting to better understand how to incentivize innovation in this space while communicating necessary information to stakeholders on how to use these products safely and effectively. View the   webinar .

Duke-Margolis on RWE Transparency Initiative

Duke-Margolis Managing Associate   Nirosha Mahendraratnam Lederer discussed the Real-World Evidence   Transparency Initiative   Partnership on The Evidence Base. Nirosha also recently addressed this issue at the ISPOR Europe 2019 meeting.The Transparency Initiative is a joint collaboration and ongoing effort between ISPOR, the International Society for Pharmacoepidemiology, Duke-Margolis, and the National Pharmaceutical Council. The objective of this initiative is to establish a culture of transparency for study analysis and reporting of hypothesis evaluating real-world evidence studies on treatment effects.   Read the interview.

Duke Search for a Professor of Medicine in Health Policy

Duke University School of Medicine has extended its invitation for applications and nominations for a Professor of Medicine with a focus in health policy and health care reform. Candidates should have a record of outstanding scholarship in academic medicine and health policy and management, along with a commitment to excellence in research, education, and mentoring, and an interest in ongoing work on policy analysis and implementation. The faculty member will be a Duke-Margolis Core Faculty Member and have a joint faculty appointment in one or more of the clinical science or basic science Departments at the School of Medicine, depending on fit. Duke University School of Medicine and Health System are very interested in having a diverse candidate pool and would be particularly interested in women and those from other groups underrepresented in medicine. 

Interested individuals should submit a statement of interest and a Curriculum Vitae online at   https://academicjobsonline.org/ajo/jobs/15504   by February 14, 2020. Applications will be kept

confidential. 

People

Boucher Named to AGING Initiative Scholars Program

Nathan Boucher , a Duke-Margolis Core Faculty member, was named one of 10 scholars in the   AGING Initiative   MCC (Multiple Chronic Conditions) Scholars Program, funded by the National Institute on Aging. This cohort of emerging leaders is committed to pursuing training and collaborative opportunities to align their research interests and agendas with issues relevant to the health and healthcare of older adults with MCCs.

Upcoming Events

Addressing Challenges in Payment and Access to Treatments for Early-Stage Alzheimer’s Disease

New treatments are on the horizon to treat Alzheimer’s disease (AD), which afflicts millions of Americans. But most of these early-stage treatments will likely enter the market with limited evidence about their impact and duration, raising uncertainties for payers and patients. Duke-Margolis, with support from the Global CEO Initiative for Alzheimer’s Disease (CEOi), will hold a February 13 webinar, from 11:00-12 noon (ET) to discuss an exploration of reimbursement approaches that could enhance access and understanding of new AD drugs as well as areas where improved tracking and outcomes could lead to better coverage.  Learn more and register for this event .

Improving Serious Illness Care in Medicare Advantage

On  Thursday, February 13 ^th  1:00-2:00 pm  (ET), the Coalition to Transform Advanced Care (C-TAC) will host a public webinar highlighting Duke-Margolis issue brief,  Improving Serious Illness Care in Medicare Advantage: New Regulatory Flexibility for Supplemental Benefits .  Duke-Margolis Researchers Hannah Crook and Rachel Roiland will discuss how Medicare Advantage plans are leveraging recent regulatory changes regarding supplement benefit offerings to meet the needs of beneficiaries with serious illness.  Learn more about the webinar .

"Opening Up While Locking Down: Building the Digital Platform for Care Delivery Reform": Special February 19 Event

Join us on February 19 at Duke's Fuqua School of Business, Geneen Auditorium from 8:45-10:15 am for the next Duke-Margolis and Blue Cross NC Point of Care speaker event. The featured speaker is Aneesh Chopra, president of CareJourney and the first US Chief Technology Officer. Aneesh will share his view of consumers taking a more active role in navigating the health care delivery system, empowered with greater access to their own data and a growing number of apps and navigation support services that can help them make better decisions at each step of their care journey.

The live streamed event will be held on Duke's campus at the Fuqua School of Business. Breakfast and beverages will be provided. Learn more and register for this event .