Outreach & Engaged Scholarship
United Kingdom
United States of America
United States of America
Service to the Profession
The group includes members from academia, industry, patients and healthcare professionals with expertise in areas such as data protection, developing standards and guidance for anonymisation and re-analysis of clinical data. EMA established the group following a public call for applications launched in March 2017.
Service to Duke
Review academic performance issues and honor code violations
In 2015, an IOM consensus study report, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk called upon stakeholders to foster a culture of sharing and offered a blueprint for action within and across sectors. Subsequent forums generated wide support and collaboration among the various stakeholders and to help address barriers and challenges to enabling the responsible sharing of data. Funders, industry and other stakeholders have developed policies and approaches to share data. One area that has not achieved widespread adoption is sharing early phase clinical research generated by academic centers and health systems. These studies are often the pivotal, proof of concept studies that lead to major investments by NIH or industry and inform the critical path for accelerated approval or adaptive approvals of new medical products. Ensuring the quality and reproducibility of results from pivotal studies is vital for a healthy research and development ecosystem for all stakeholders. The reasons for the lack of open science in this early phase area may be due to the diversity of research, incentive structures that favor individuals as opposed to teams, protection of intellectual property and/or practical difficulties.
To address this frontier, a roundtable is being convened to develop a “statement” to convey both aspirational and practical research data sharing goals and strategies for the academic health system environment. A priority of the roundtable is to develop actionable goals that could be brought to academic institutional leadership, and boards to incorporate data sharing policies focused on early phase clinical research. The meeting today aims to: (1) bring together a group of stakeholders to discuss and improve upon data sharing goals and, (2) provide a launching point for the prioritization and uptake of data sharing activities among an academic health systems engaged in early phase clinical research.
The Duke-Margolis Center for Health Policy, in collaboration with the U.S. Food & Drug Administration (FDA), is convening experts in blood pressure research and ambulatory blood pressure monitoring measurement from the regulatory, academic, and drug development communities to discuss the premarketing assessment of a drug's effect on blood pressure. Following a recently published draft guidance, “Assessment of Pressor Effects of Drugs”, FDA is specifically interested in soliciting feedback regarding four high-priority topics:
1. Understanding the temporal relationship between changes in blood pressure and changes in risk.
2. Interpreting results of the PRECISION study and its relevance to the pressor guidance.
3. Is there a BP increase of concern applicable across development programs or should each development program take its risk tolerance into consideration? What is the role of the patient population?
4. The necessity of using placebo groups as controls in ABPM studies.
Under a cooperative agreement with FDA, the Duke-Margolis Center for Health Policy is convening this expert workshop to provide stakeholders the opportunity to explore potential quantitative and decision-analytic approaches for evaluating complex review decisions to support structured B-R assessment.
The specific objectives for the meeting are to discuss: 1) key considerations for ensuring that B-R analysis tools are fit-for-purpose in FDA’s drug regulatory context, 2) the types of regulatory decisions suitable for implementing analytic B-R approaches, and 3) strategies for incorporating patient input (derived through both qualitative and quantitative methods) into structured B-R assessment.
Input from this meeting will support the Agency in its continued efforts to advance and integrate structured benefit-risk assessment in FDA’s human drug review.
Academic & Administrative Activities
Serve and/or Chair on >12 Data Monitoring Committees
Have served in the past on >50 data monitoring committees