Expert Scientific and Statistical Consulting Services
Strategic clinical and scientific support for a wide range of organizations—pharmaceutical, biotechnology, non-profit, academic, and government research institutes—powered by internationally recognized expertise, steadfast integrity, and deep commitment to improving public health.
Frank W. Rockhold, ScM, PhD, PStat®, CSTAT, FASA, FSCT
Professor of Biostatistics, Duke University School of Medicine
Scientific Consultant, HunterRockhold, Inc.
A unique approach
Most statistical consultants and experts can plan and perform statistical analyses; but few are experienced in the strategic considerations that are essential to new medicine development. Even fewer are experienced and expert in safety, pharmacovigilance, and benefit-risk assessments.
Dr. Rockhold brings over 50 years of global experience in the statistical aspects of drug development and the regulatory process. He works with clients to design research plans, clinical trials, pharmacovigilance, safety, and benefit-risk strategies.
Embedded in his wide range of expertise is a deep personal commitment to putting the patient at the center of medicine development. A man of unshakable integrity, he firmly believes in patient safety, transparency, and balancing the benefits of a potential new medicine with risks to health and wellbeing.
About Frank
Frank is a Professor of Biostatistics and Bioinformatics at Duke University Medical Center (Scholars at Duke), an Affiliate Professor of Biostatistics at Virginia Commonwealth University, and Scientific Consultant with HunterRockhold, Inc. His 50+ year career includes senior research positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer and Senior Vice President of Global Clinical Safety and Pharmacovigilance. He has also held faculty appointments at six universities.
Dr. Rockhold is internationally recognized for his expertise in clinical trial design, safety and pharmacovigilance, public data disclosure and scientific transparency. He has presented at FDA Advisory Committee meetings, Japanese and European regulatory agencies, National Academy of Science, Institute of Medicine, and the White House Office of Technology and Science. He is currently an advisor to the Patient Centered Outcomes Research Institute as part of the Affordable Care Act.
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Chief Safety Officer and Head of Global Clinical Safety and Pharmacovigilance
Chaired Global Safety Board and internal Data Monitoring Committee
Head of Cardiovascular Research
Head of Biostatistics, Epidemiology and Health Informatics with groups in US, Asia and Europe and a staff of 1500
Head of Clinical Operations
Worked on more than 500 new molecular entities in every therapeutic area, including vaccines and consumer health
Involved in the design or analysis of more than 2000 clinical trials
Led the development of the world’s first protease inhibitor for AIDS from clinical trials to market.
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Chief Safety Officer and Head of Global Clinical Safety and Pharmacovigilance
Chaired Global Safety Board and internal Data Monitoring Committee
Head of Cardiovascular Research
Head of Biostatistics, Epidemiology and Health Informatics with groups in US, Asia and Europe and a staff of 1500
Head of Clinical Operations
Worked on more than 500 new molecular entities in every therapeutic area, including vaccines and consumer health
Involved in the design or analysis of more than 2000 clinical trials
Led the development of the world’s first protease inhibitor for AIDS from clinical trials to market.
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Full Professor of Biostatistics and Bioinformatics, Duke University School of Medicine (current)
Affiliate Professor of Biostatistics, Virginia Commonwealth University Medical Center (current)
University of Pennsylvania, Adjunct Scholar, Epidemiology and Biostatistics
Penn State College of Medicine, Adjunct Professor, Department of Public Health Sciences
Medical College of Virginia/Virginia Commonwealth University, Graduate Faculty, Department of Biostatistics
Indiana University School of Business Administration, Lecturer, Department of Quantitative Business Analysis
Butler University School of Business Administration, Lecturer, Department of Management Science
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Clinical Trial Design
Safety and Pharmacovigilance
Data Disclosure and Transparency
Data Monitoring Committees
Benefit-Risk Estimation
Data Standards
Advisory Committee Preparation and Review
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President Society for Clinical Trials
Pharmaceutical Research Manufacturers of America – Chaired Biostatistics Committee
ICH: Member, ICH Expert Working Group (E1) on Extent of Population Exposure, ICH Expert Working Group (E9) on Biostatistics Guidelines for Clinical Trials, and ICH Expert Working Group (E10) on Choice of a Control Group.
World Health Organization – Scientific Advisory Group for the International Clinical Trials Registry Project
Clinical Data Interchange Standards Consortium (CDISC), Chair and Member Board of Directors
National Library of Medicine Board of Regents Clinical Trial Working Group.
Patient Centered Outcomes Research Institute Advisory Panel on Clinical Trials
Frontier Science and Technology Research Institute, Chairman of the Board of Directors (current)
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Fellow, American Statistical Association.
Fellow, Society for Clinical Trials
Fellow Royal Statistical Society
ACCREDITED PROFESSIONAL STATISTICAN™ PStat®, 2012
Chartered Statistician, CStat
Career Achievement Award, PhRMA
Named Outstanding Alumnus from Medical College of Virginia, Graduate School of Health Sciences, 1993
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Frank holds a BA in Statistics from The University of Connecticut, an ScM in Biostatistics from The Johns Hopkins University, and a PhD in Biostatistics from the Medical College of Virginia at Virginia Commonwealth University.
Credentials at-a-glance
Involved in the design or analysis of more than 2,000 clinical trials.
2,000
Worked on more than 500 new molecular entities in every therapeutic area, including vaccines and consumer health, new indications, and combination products
500
More than 250 publications in peer- reviewed scientific journals.
250+
Served on and chaired more than 100 data monitoring committees.
100+
50+ years global experience in the statistical aspects of drug development and the regulatory process.
50+
Delivered more than 350 presentations at Scientific Symposia.
350+
Services
Clinical Trial and Research Program Design
Frank’s experience includes designing clinical trials in all therapeutic areas across pharmaceutical, vaccines, and consumer products. His experience running clinical operations, various clinical research functions, clinical safety, as well as 30+ years leading biostatistics and epidemiology functions, has given him a diverse, in-depth view of many aspects of clinical research covering hundreds of development programs. In addition to a long history of interaction with regulatory agencies in the US, Canada, Europe, and Japan on development projects, Frank served on three expert working groups (E1, E9, E10), for the International Conference on Harmonization (ICH) and has presented at FDA and EMA advisory committee meetings. He is a Fellow and past president of the Society for Clinical Trials and a Fellow of the American Statistical Association and the Royal Statistical Society. Frank is able to design an individual trial, a group of trials, or an entire development program for his clients.
Data Monitoring Committees
Frank has been publishing on data monitoring issues for more than 25 years and was responsible for overseeing the creation of hundreds of data monitoring committees in his 35+ years at GlaxoSmithKline. As head of the safety department, he was the point person for all communications with these committees. Now as a member of academia, he has served on 100+ DMC’s and currently serves on numerous independent data monitoring committees. As a member of Duke Clinical Research Institute, Frank is helping to develop a training program for data monitoring committees and new committee members. Frank can help organize and serve on an independent data monitoring committee for an individual clinical trial or a series of trials within a research program.
Scientific and FDA Advisory Committee Preparation and Review
Frank’s extensive experience in numerous areas of clinical research and with the regulatory environment makes him a valuable member of any Scientific Advisory Board, mock FDA Advisory Committee meeting rehearsal, or Research Review Board. He routinely serves that role with PCORI and the California Institute of Regenerative Medicine and on Safety Advisory Boards for other clients. With this background he is able to review documentation for scientific accuracy and clarity and provide advice on how research proposals might be viewed by other Regulatory and Scientific Advisory Boards.
Safety and Pharmacovigilance
Frank’s 15 years on a corporate global safety board (9 years as chair) and 8 years as Chief Safety Officer for GlaxoSmithKline (responsible for 800+ products in 100+ countries) provides an extensive background in safety methodology in all therapeutic areas across pharmaceuticals, vaccines, and consumer health. His safety expertise includes safety for clinical trial and marketed product signal detection methodology, thorough knowledge of international safety regulations, and organizational safety governance. Frank can help institutions of all types and sizes to review individual product safety issues as well as improve the functioning of a pharmacovigilance function.
Data Disclosure and Transparency
Frank is a leader in the scientific community promoting data disclosure and transparency in clinical research. His experience has spanned protocol registration, results disclosure, and sharing of individual patient data. He has published and presented extensively on the subject and has advised WHO, NIH, PCORI, Harvard’s Multiregional Clinical Trials Center, and other government agencies on transparency strategies. He is currently involved in three collaborative efforts on data sharing. Frank was a pivotal figure in the design and launch of what is now www.clinicalstudydatarequest.com, the Principal Investigator of the SOAR open science platform at Duke, and Senior Advisor to Vivli, the world’s largest data sharing platform. Frank has extensive knowledge of international regulations and professional guidelines affecting data sharing, and he helps institutions develop policies and guidelines on clinical data disclosure and transparency. He also helps clients develop programs to make relevant information available to patents and health care providers to meet the expectations of patients, regulatory agencies, and professional organizations.
Benefit-Risk Estimation
Frank has been working on the development of guidelines for benefit-risk for 20+ years. He was a flagship member of the Benefit Risk Action Team (BRAT) which developed a set of guidelines that are used today and served as the basis for many institutions’ benefit-risk framework. In addition, for three years he was an advisor to the Center for Innovation in Regulatory Science (CIRS) on benefit-risk guidelines and helped develop their extension of BRAT, called UMBRA. Frank was instrumental in establishing a governance structure with GSK for benefit-risk evaluation and review, resulting in a standard template for benefit-risk required for use from first-time-in-man through the marketed lifecycle of a product. He has given over a dozen invited papers on this topic over the last five years, and in particular has been engaged in patient level benefit-risk issues. He can help an institution implement a framework for benefit-risk or help describe and evaluate benefit-risk characteristics of an individual treatment.
Partial client list
What People Are Saying
“I have learnt a lot working with Frank over the past fifteen years. He brings calm demeanor and wise counsel, and he lives the values of integrity, transparency, and patient focus every day.”
— Head of Regulatory Affairs“I’m grateful to Frank for his steady advice, direction, and leadership over my years as a safety physician. His pragmatism and willingness to fairly assess risk always stood out to me. He has a knack for summarizing that helps others, and people benefit from his experience, wisdom, and leadership style.”
— Pharmacovigilance Medical Director“I appreciate Frank’s leadership style, especially in times of adversity. He is wise, calm, firm when he needs to be, and always committed to what is best for patients He evokes trust, and a confidence in forthrightness and transparency.”
— Pharmacovigilance Medical Director