Frank specializes in supporting the strategic clinical and scientific needs of pharmaceutical, biotechnology, non-profit, academic and government research institutes from an experienced statistical and clinical research perspective.

HunterRockhold, Inc. provides a unique, highly experienced, internationally recognized statistical resource that assists clients in designing and evaluating clinical research plans, study designs, regulatory strategies, and regulatory submissions. We also have a unique experience in clinical safety and pharmacovigilance, benefit to risk estimation and public data disclosure and transparency policy and strategy.

Please take a moment to browse our services below and let us know if Frank can help you and your research institute.

Clinical Trial and Research Program Design

Frank’s has 40+ years of experience in designing clinical trials in all therapeutic areas across pharmaceutical, vaccines, and consumer products. His experience in running clinical operations, various clinical research functions, clinical safety as well as 30+ years leading biostatistics and epidemiology functions has given him a diverse and 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 personally 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. This background and experience give him the ability to design an individual trial, a group of trials, or an entire development program.

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) has provided an extensive background in safety methodology in all therapeutic areas across pharmaceuticals, vaccines, and consumer health. He has expertise in safety both 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 in reviewing both individual product safety issues as well as how to improve the functioning of a pharmacovigilance function

Data Disclosure and Transparency

Frank has been a leader in the scientific community in promoting data disclosure and transparency in clinical research. His experience has spanned protocol registration, results disclosure, and sharing of individual patient data.  Frank has published and presented extensively on the subject and been an advisor on transparency strategies to WHO, NIH, PCORI, Harvard’s Multiregional Clinical Trials Center, and other government agencies and is currently involved in 3 collaborative efforts on data sharing.   He was a pivotal figure in the design and launch of what is now, 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.  He can help your institution develop policies and guidelines on clinical data disclosure and transparency and to develop a program to make relevant information available to patents and health care providers that will meet the expectations of patients, regulatory agencies and professional organizations.

Data Monitoring Committees

Frank has been publishing on data monitoring issues for more than 25 years and for more than 15 years was responsible for overseeing the creation hundreds of data monitoring committees in his time at GlaxoSmithKline.  In addition, 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 30+ DMC’s and currently serves on numerous independent data monitoring committees.  Frank is helping to develop a training program for data monitoring committees and training of new committee members as a member of Duke Clinical Research Institute.    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.

Benefit to Risk estimation

Frank has been working on the development of guidelines for benefit to risk for more than 15 years and was a flagship member of the Benefit Risk Action Team (BRAT) which developed a set of guidelines that are used today by many and served as the basis for many institutions benefit to risk framework.  In addition, for 3 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 to risk evaluation and review resulting in a standard template for benefit to 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 5 years and in particular been engaged in patient level benefit to 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.

Scientific and FDA Advisory Committee Preparation and Review

As extension of his extensive experience in numerous areas of clinical research and experience with the regulatory environment, Frank can be a valuable member of any scientific advisory board, mock FDA advisory committee meeting rehearsal, or research review board.   He serves that role with PCORI and the California Institute of Regenerative Medicine on a routine basis and on safety advisory boards for other clients.   This background allows him to review documentation for scientific accuracy and clarity and provide advice on how research proposals might be viewed by other regulatory and other scientific advisory boards.

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