The Math of Ethical Clinical Trials

Philippe Rigollet, faculty

The design of ethical clinical trials must compromise between caution (testing one subject at a time) and efficiency (all of them simultaneously). The former optimizes outcomes for the most patients but is impractical; the latter maximizes the speed of research, but sacrifices potential benefits to a large segment of study enrollees. A solution is to group subjects into smaller batches: the FDA currently recommends four batches, but their size is not precisely regulated. Associate professor of mathematics Rigollet and his collaborators developed a mathematical technique for sizing each batch. They have demonstrated that by applying their rule, four batches can yield patient outcomes comparable to the most cautious procedure of testing subjects one at a time, while presenting almost no loss of efficiency in relation to current standards.