2016 Annual Report
Learn about the Duke-Margolis Center's founder, our accomplishments in our first year, and the outstanding faculty and staff who make it all happen!
Publications
Selected Peer Reviewed Publications 2016
Selected Peer Reviewed Publications for the calendar year 2016 are listed below:
NEST: Priorities for Early Effective Implementation
This is the third in a series of reports from the Planning Board to support the U.S. Food and Drug Administration’s (FDA) work to establish the National Evaluation System for health Technology (NEST). NEST is envisioned as a cooperative network of partners working to use data, advanced...
Improving Productivity in Pharmaceutical Research and Development: The Role of Clinical Pharmacology
This white paper explores strategies for a more robust application of clinical pharmacology in drug development and regulatory review. Duke-Margolis staff and a working group of experts provide an overview of the key opportunities stakeholders have to leverage clinical pharmacology tools to...
Pioneering Statistical Approaches to Accelerate Drug Development through Adaptive Trial Designs
In recent years, experts in the development and regulation of medical products have explored promising new adaptive clinical trial designs to help speed innovative new therapies to patients in need. This white paper, based on...
Facilitating Biomarker Development: Strategies for Scientific Communication, Pathway Prioritization, Data-Sharing, and Stakeholder Collaboration
In this white paper, a working group of experts address key challenges in biomarker development and validation, including inconsistent terminology; confusion surrounding the various regulatory pathways for biomarker acceptance; the need for data standards and improved collaboration in data...
United States Must Move Quickly to Combat Superbugs
As officials reel from the news that a “superbug” strain of E-coli resistant to colistin, the antibiotic of last resort, has arrived in the United States, leaders in Europe have issued guidance on policy measures aimed at avoiding this worst-case scenario. Dangerous bacteria are becoming...