Frank Wesley Rockhold

Advisor, Proactive Safety Surveillance · November 2018 Committee Service Multi-Regional Clinical Trials Center, Brigham and Woman's Hospital and Harvard

Advisor, Clinical Trials Diversity · June 2018 Committee Service Multi-Regional Clinical Trials Center, Brigham and Woman's Hospital and Harvard

Member RWD Working group · 2018 Committee Service American Statistical Association

Peer Reviewer · 2018 - 2020 Editorial Activities American Statistician

United States

Member, Trial of the Year Committee · 2017 Committee Service Society for Clinical Trials

Member program committee, FDA-ASA Statistics Workshop · 2017 - 2019 Committee Service American Statistical Association

Peer Reviewer · 2017 - 2020 Editorial Activities Trials

United Kingdom

Advisor, Technical Anonymization Group · 2017 - 2021 Committee Service European Medicines Agency, London, UK 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.

Peer Reviewer · 2017 - 2022 Editorial Activities PLOS One

United States

Peer Reviewer · 2017 - 2022 Editorial Activities JAMA

United States

Peer Reviewer · 2017 - 2020 Editorial Activities Circulation

United States

Member program committee, FDA-DIA Statistics Forum · 2017 - 2021 Committee Service Drug Information Association

Peer Reviewer · 2016 - 2022 Editorial Activities Pharmaceutical Statistics

Member Safety Methods Workgroup · 2016 - 2019 Committee Service American Statistical Association

Peer Reviewer · 2016 - 2022 Editorial Activities New England Journal of Medicine

United States

Peer Reviewer · 2016 - 2022 Editorial Activities JAMA Cardiology

United States

Peer Reviewer · 2016 - 2022 Editorial Activities Statistics in Biopharmceutical Research

Peer Reviewer · 2016 - 2020 Editorial Activities Pharmacoepidemiology and Drug Safety

United States

Senior Advisor, Advisory Board · June 2015 Committee Service Vivli

Editorial Advisory Board of Pharmaceutical Statistics · 2015 Editorial Activities Wiley

Chairman, Board of Directors · 2015 - 2022 Committee Service Frontier Science and Technology Foundation, Boston

Advisor, Clinical Trial Advisory Panel · 2014 - 2017 Consulting Patient Center Outcomes Research Institute (PCORI), Washington, DC

Member, Board of Regents Clinical Trial Working Group · 2007 - 2010 Committee Service National Library of Medicine, Bethesda, MD

Member, Scientific Advisory Group for the International Clinical Trials Registry Project · 2005 - 2008 Committee Service World Health Organization, Geneva

Chair, Board of Directors · 2004 - 2013 Committee Service Clinical Data Interoperability Standards Consortium (CDISC)

President · 1995 - 1998 Other Society for Clinical Trials, Baltimore

Expert: E1, E9, E10, International Conference on Harmonization · 1992 - 2000 Other ICH, Brussels A member of the expert working groups for ICH Guidelines E1, E9, and E10

Director, Board of Directors · 1989 - 1993 Committee Service Society for Clinical Trials, Baltimore

Service to Duke

Committee on Culture, Diversity and Inclusion (Department) · October 2019 Committee Service Biostatistics and Bioinformatics

Research Misconduct (School) · September 2019 Committee Service Duke University School of Medicine

Advisor, Duke-Margolis RWEndpoints Workgroup · July 7, 2019 - February 2020 Other Duke-Margolis

Academic Review Committee (Department) · July 2019 Committee Service Biostatistics and Bioinformatics Review academic performance issues and honor code violations

Presenter, Duke Open Science Roundtable · February 27, 2019 - February 27, 2019 Event Participation Duke University School of Medicine, Washington DC 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.

Expert Advisor, "Evaluating the Pressor Effects of Drugs & Ambulatory Blood Pressure Monitoring Studies" · February 4, 2019 - February 4, 2019 Event Participation Duke-Margolis, Washington DC 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.

PhD Admissions Committee (Department) · November 2018 Committee Service Biostatistics and Bioinformatics

Chair Search for Biostatistics and Bioinformatics (University) · August 2018 - March 2019 Committee Service Medical School

Strategic Planning Group (Division) · 2018 - 2019 Committee Service Duke Clinical Research Institute

Expert Advisor, Advancing Structured Benefit-Risk Assessment in FDA Review · October 4, 2017 - October 4, 2017 Event Participation Duke-Margolis, Washington DC 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.

Duke Industry Statistics Symposium (Consortium) · 2016 - 2020 Committee Service Biostatistics and Bioinformatics, Durham

Leadership & Clinical Positions

Interim Faculty Director Biostatistics, DCRI, 2022-

Academic & Administrative Activities

Serve and/or Chair on >12 Data Monitoring Committees
Have served in the past on >50 data monitoring committees

Duke Initiatives

Faculty Mentor Fellow Mentor PhD Student Mentor Post-Doc Mentor