Bioethics Blogs

Why clinical translation cannot succeed without failure

Attrition in drug development – that is, the failure of drugs that show promise in animal studies to show efficacy when tested in patients- is often viewed as a source of inefficiency in drug development. Surely- some attrition is just that. However, in our recent Feature article in eLife, my long time collaborator Alex London and I argue that some attrition and failure in drug development directly and indispensably contributes to the evidence base used to develop drugs and practice medicine.

How so? We offer 5 reasons. Among them is the fact that negative drug trials provide a read on the validity of theories driving drug development; and that negative drug trials provide clarity about how far clinicians can extend the label of approved drugs. Another is that it is far less costly to deploy cheap (but error prone) methods to quickly screen vast oceans and continents of drug / indication / dose / co-intervention combinatorials. To be clear- our argument is not that failure in drug development is a necessary evil. Rather, we are arguing that at least some failure is constitutive of a healthy research enterprise.

So what does this mean for policy? For one, much of the information produced in unsuccessful drug development remains locked inside the filing cabinets of drug companies (see our BMJ and BJP articles). For another, even the information that is published is probably underutilized (see, for example, Steven Greenberg’s analysis of how “negative” basic sciences are underutilized in the context of inclusion body myositis).

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.