C1A/C1B

Chair: Robert Barrier (Parexel)
Vice Chair: Marlina Nasution (Parexel)

Agenda

Instructors:
Frank Rockhold, PhD
Professor, Department of Biostatistics and Bioinformatics
Duke University School of Medicine
Frank is a fulltime Professor of Biostatistics and Bioinformatics at Duke University Medical Center, 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 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 on 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.
Susan Ellenberg, PhD
Professor, Department of Biostatistics, Epidemiology and Informatics
University of Pennsylvania
Dr. Susan Ellenberg is Professor of Biostatistics and Interim Chair, Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania. Prior to her appointment at Penn, Dr. Ellenberg held positions of increasing responsibility in the federal government. From 1993 to 2004 she served as Director, Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration; prior to that she served as the first Chief of the Biostatistics Research Branch in the Division of AIDS, National Institute of Allergy and Infectious Diseases (1988-1993), and served in the Biometric Research Branch in the Cancer Therapy Evaluation Program, National Cancer Institute (1982-1988).

Dr. Ellenberg is a Fellow of the American Statistical Association, the Society for Clinical Trials and the American Association for the Advancement of Science, and is an elected member of the International Statistical Institute. She is a recipient of the 2018 Janet Norwood Award and the 2019 F.N. David Award, both awards given to a female statistician for outstanding achievements. A second edition of her book, Data Monitoring Committees in Clinical Trials: A Practical Perspective, co-authored with Drs. Thomas Fleming and David DeMets, was released in March 2019.

Scott Evans, PhD
Professor, Department of Biostatistics Bioinformatics
George Washington University
Dr. Scott Evans is a Professor and Founding Chair of the Department of Biostatistics Bioinformatics and the Director of the George Washington Biostatistics Center. Professor Evans interests include the design, monitoring, analyses, and reporting of and education in clinical trials and diagnostic studies. He is the author of more than 100 peer-reviewed publications and three books on clinical trials including Fundamentals for New Clinical Trialists. He is the Director of the Statistical and Data Management Center (SDMC) for the Antibacterial Resistance Leadership Group (ARLG), a collaborative clinical research network that prioritizes, designs, and executes clinical research to reduce the public health threat of antibacterial resistance. He was recently interviewed for Stats + Stories on NPR to discuss his research on superbug infections (https://statsandstories.net/health1/superbug-statistics). Dr. Evans is a recipient of the Mosteller Statistician of the Year Award, the Robert Zackin Distinguished Collaborative Statistician Award for contributions to the AIDS Clinical Trials Group (ACTG), an elected member of the International Statistical Institute (ISI), and is a Fellow of the American Statistical Association (ASA), Society for Clinical Trials (SCT), and the Infectious Disease Society of America (IDSA). Professor Evans is a member of the Board of Directors for the American Statistical Association (ASA) and formerly for the Society for Clinical Trials (SCT) and the Mu Sigma Rho (the National Honorary Society for Statistics). He is a member of an FDA Advisory Committee, the Steering Committee of the Clinical Trials Transformation Initiative (CTTI), the Executive Committee for the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, and Networks (ACTTION), and serves as the Chair of the Trial of the Year Committee of the SCT. Professor Evans is the Editor-in-Chief of CHANCE and Statistical Communications in Infectious Diseases (SCID), the Co-Editor of a Special Section of Clinical Infectious Diseases (CID) entitled Innovations in Design, Education, and Analysis (IDEA), and an Advisory Editor for Statistics in Biopharmaceutical Research. Professor Evans has served on numerous DSMBs for government and industry-sponsored clinical trials including as Chair of the DSMBs for the Adolescent Trials Network (ATN) and for a clinical trial of microbial restoration in Clostridium difficile associated disease (CDAD), an “urgent” hazard level pathogen.

Matt Downs, MPH
Statistics Collaborative, Washington DC
Since 1999, Mr. Downs has served as the independent reporting statistician to industry-sponsored Data Monitoring Committees (DMCs). The trials on which he has worked have spanned small studies in orphan indications to multinational cardiovascular outcome trials of over 10,000 participants. His work with industry sponsors has ranged from preparation of DMC charters and interim analysis plans to managing the statistical programming and interim report writing. In addition to reporting to DMCs, he has also served on industry- and government-sponsored committees as the voting DMC statistician.