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Frank Wesley Rockhold

Professor of Biostatistics & Bioinformatics
Biostatistics & Bioinformatics, Division of Biostatistics
Duke Box 3850, Durham, NC 27710
200 Morris Street, 6428 200 Morris, Durham, NC 27701

Overview


Frank is a full time Professor of Biostatistics and Bioinformatics and Faculty Director for Biostatistics at Duke University Medical Center, Affiliate Professor of Biostatistics at Virginia Commonwealth University, and Strategic Consultant at Hunter Rockhold, Inc.  His 40+-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 held faculty appointments at six different universities.    Dr. Rockhold served for 9 years on the board of directors of the non-profit CDISC, most recently as Chairman, and is past president of the Society for Clinical Trials and a past member of the PCORI Clinical Trials Advisory Panel. He is currently Chair of the Board of the Frontier Science and Technology Research Foundation and a technical advisor to EMA.

Dr. Rockhold has diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, benefit/risk, safety and pharmacovigilance and has been a leader in the scientific community in promoting data disclosure and transparency in clinical research.    Frank is widely published in major scientific journals across a wide variety of research topics.

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. Frank is an Elected Fellow of both the American Statistical Association and the Society for Clinical Trials, a Fellow of the Royal Statistical Society, an Accredited Professional Statistician, PStat®, and a Chartered Statistician, CStat.  

Current Appointments & Affiliations


Professor of Biostatistics & Bioinformatics · 2021 - Present Biostatistics & Bioinformatics, Division of Biostatistics, Biostatistics & Bioinformatics
Member in the Duke Clinical Research Institute · 2016 - Present Duke Clinical Research Institute, Institutes and Centers

In the News


Published December 17, 2019
Medical College of Virginia Power Alumini
Published November 26, 2019
Data Monitoring Committees Need Complete Data to Protect Patients
Published July 19, 2019
Open Data Critical to Clinical Research

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Recent Publications


SPIRIT 2025 statement: updated guideline for protocols of randomized trials.

Journal Article Nat Med · April 29, 2025 The protocol of a randomized trial is the foundation for study planning, conduct, reporting and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol ... Full text Link to item Cite

SPIRIT 2025 statement: updated guideline for protocols of randomised trials.

Journal Article BMJ · April 28, 2025 IMPORTANCE: The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Stand ... Full text Link to item Cite
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Recent Grants


Integrated Biostatistical Training for CVD Research

Inst. Training Prgm or CMEMentor · Awarded by North Carolina State University · 2022 - 2027

Infrastructure for Musculoskeletal Pediatric Acute Care Clinical Trials (IMPACCT)

ResearchStatistical Investigator · Awarded by Ann & Robert H Lurie Children's Hospital of Chicago · 2021 - 2026

Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss

ResearchCo Investigator · Awarded by Patient-Centered Outcomes Research Institute · 2021 - 2026

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Education, Training & Certifications


Virginia Commonwealth University · 1979 Ph.D.
Johns Hopkins Unversity, Bloomberg School of Public Health · 1977 Sc.M.