About Frank

Frank Rockhold Bio

Frank is a Professor of Biostatistics and Bioinformatics at Duke University Medical Center (Scholars at Duke), Affiliate Professor of Biostatistics at Virginia Commonwealth University, and Managing Partner of HunterRockhold, 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 also held faculty appointments at six 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. He is a past member of the PCORI Clinical Trials Advisory Panel and is currently on the boards of the Frontier Science and Technology Research Foundation, Datavant, and an advisor to EMA.

Dr. Rockhold has diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, benefit/risk, and most recently, 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, an Accredited Professional Statistician, PStat®, and a Chartered Statistician, CStat.

About HRI Statistical Consulting

Most statistical consultants and experts can plan and perform statistical analyses, but few are experienced in the strategic considerations that are essential components in the development of a new medicine.  Even fewer are experienced and expert in safety, pharmacovigilance and benefit to risk.  Dr. Rockhold brings more than 40 years of global experience in the statistical aspects of drug development and the regulatory process.  He will work with you to design research plans, clinical trials, pharmacovigilance, safety and benefit to risk strategies.

Dr. Rockhold’s experience base includes directing statistical and clinical aspects of global submissions for more than 500 new molecular entities in every therapeutic area including vaccines and consumer products, new indications, and combination products.  He has presented personally at FDA advisory committee meetings, Japanese and European regulatory agencies, National Academy of Science, Institute of Medicine, White House Office of Technology and Science and is currently an to the Patient Centered Outcomes Research Institute as part of the Affordable Care Act.   Frank has been involved in over 2000 clinical trials and also has unique and international recognized experience in the areas of public data disclosure and scientific transparency.

Dr. Rockhold has served on and chaired more than 30 data monitoring committees≥

This diverse and unique set of experiences will add significant value to your research projects.