IRBs could use pre-clinical data better
In this week's PLoS Medicine, Jonathan Kimmelman from McGill University in Montreal, Canada and Alex London from Carnegie Mellon University in Pittsburgh, USA argue that ethical reviewers and decision-makers pay insufficient attention to threats to validity in pre-clinical studies and consult too narrow a set of evidence. They propose a better way for ethical and scientific decision makers to assess early phase studies: first, to attend to reporting and methodological quality in preclinical experiments that support claims of internal, construct, and external validity; and ...