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
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 CiteSPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials.
Journal Article BMJ · April 28, 2025 Full text Link to item CiteSPIRIT 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 CiteRecent Grants
Integrated Biostatistical Training for CVD Research
Inst. Training Prgm or CMEMentor · Awarded by North Carolina State University · 2022 - 2027Infrastructure for Musculoskeletal Pediatric Acute Care Clinical Trials (IMPACCT)
ResearchStatistical Investigator · Awarded by Ann & Robert H Lurie Children's Hospital of Chicago · 2021 - 2026Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss
ResearchCo Investigator · Awarded by Patient-Centered Outcomes Research Institute · 2021 - 2026View All Grants