The Replication Crisis in Pharmaceutical Science

The talk begins with a discussion of why precision medicine -- specifically precision medicine with the goal of tailoring drug development to address ever smaller patient subpopulations -- will require huge amounts of data. We then show why this problem is compounded even further by the replication crisis, which is calling into question the validity of scientific research not only in areas such as social psychology but also in clinical and translational science. I then outline the proposed solutions to the replication crisis, including the strategy of preregistration of hypotheses and methods propounded by the Center for Open Science. I conclude by arguing that a strategy along these lines can work only if preregistration requires the use of controlled vocabularies (ontologies) of a sort that will allow the unambiguous specification of hypotheses and methods used.