Learn on history of bias and randomization in oncology clinical trials and how to think about what constitutes persuasive evidence of treatment efficacy and safety.
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.
KEY LEARNINGS:
Participants will learn the history of bias and randomization in oncology clinical trials (from the primitive oncology trials of 1980 to the highly regulated and complex trial design and analysis paradigm of today) and how to think about what constitutes persuasive evidence today and in the future.
SPEAKERS:
