In 1980 Jay Herson published the paper “Patient Registration in a Cooperative Oncology Group” in the first volume of Controlled Clinical Trials. The fortieth anniversary affords an opportunity to reflect on how much has changed and how much remains the same. The history of randomization 1980-2020 reflects the changes in what the research and regulatory communities considered as persuasive evidence of treatment efficacy and safety. The role of randomization is considered among the challenges of defining estimands, historical controls, real world data, Bayesian methods, pragmatic trials and COVID-19. We will conclude with imagining clinical trials in the year 2060 where machine learning using aggregate data may change our definition of persuasive evidence. We will raise the question of whether different communities (industry, academia, regulators, clinicians, patients) can co-exist each with their own definitions of persuasive evidence and how will randomization fit into these definitions.
JAY HERSON, Ph.D. Senior Associate, Biostatistics
Johns Hopkins Bloomberg School of Public Health Baltimore, Maryland, USA
Jay Herson received his Ph.D. in Biostatistics from Johns Hopkins University in 1971. Jay has developed methods for design and analysis of clinical trials with planned interim analyses and sample size re-estimation. In 1988 he organized and chaired the first data monitoring committee in the pharmaceutical industry. His book, Data and Safety Monitoring in Clinical Trials, Second Edition, Chapman and Hall, 2017 is considered the definitive guide to safety review in industry – sponsored clinical trials. He is currently working as a drug development consultant and as an adjunct faculty member in Biostatistics at the Johns Hopkins Bloomberg School of Public Health in Baltimore where he has taught in several graduate courses. He has written articles and been an invited speaker on the future of health care, medical practice and local government.
MARC BUYSE, ScD, Chief Scientific Officer at the International Drug Development Institute (IDDI).
- He holds a ScD in biostatistics from the Harvard School of Public Health (Boston, MA).
- He is the founder of the International Drug Development Institute (IDDI) and of CluePoints, two biostatistical service organizations based in the US and Europe.
- He is interested in clinical trial design, meta-analysis, validation of biomarkers and surrogate endpoints, statistical methods in oncology, statistical detection of errors and fraud, statistical monitoring of clinical trials, and medical data sharing (http://publicationslist.org/marc.buyse).