Working Group Recommends steps for using data from mobile health apps and wearables in research

On Friday, Sept. 15 ^th , Duke-Margolis released an action plan Mobilizing mHealth Innovation for Real-World Evidence Generation during a public event. This action plan was supported through a cooperative agreement with FDA and in collaboration with an expert working group from across the healthcare and mHealth ecosystem. The  action plan  outlines the challenges and potential solutions to make data derived from consumer and clinical-use mobile apps and wearables useable for secondary research purposes on medical products. Read more

Workshop on Regulatory Use of Real-World Evidence:

Informal Comment Period to Extend to October 11, 2017

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.

Duke Margolis would like to continue to solicit feedback on the white paper and its proposed framework through an informal comment period that will end Wednesday, October 11, 2017. Read more

Sanders-Schmidler Receives Leadership Award from SMDM

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.

DGHI and Duke-Margolis Launch Global Health Innovation Center

This summer, DGHI and partners across Duke launched the Duke Global Health Innovation Center (GHIC) to study and support the scaling and adaptation of health innovations, and related policy reforms, to address critical health challenges worldwide. Krishna Udayakumar, associate professor of global health and medicine and executive director of Innovations in Healthcare, leads the center. Read more

Greg Daniel, PhD, MPH , was quoted in Politico Pr o, " Hopes for new FDA data system to expand device safety and use". He was also a featured speaker at The Hill's event, "Turning Genes Into Medicine" at the Newseum in Washington, DC on September 12.

Monika Schneider, PhD, presented at the World Antimicrobial Resistance Congress on challenges and incentives for development of diagnostics for bacterial infections.

David Anderson published "Medicaid Waivers Should Backstop the Exchanges" on the Health Affairs Blog.

Mark McClellan, MD, PhD, MPA moderated a panel on payment reform at the Texas Medical Center Health Policy annual meeting. He was also an invited speaker at Research!America's National Health Research Forum, "Is a Disease-free World Within Reach?"

View Past Webcasts and More

Duke-Margolis Center for Health Policy archives webcasts of public events and posts public event summaries on our website. Read More