IRBs could use pre-clinical data better
Wednesday, March 9, 2011 - 14:20
in Psychology & Sociology
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 second, to consider evidence on risks and benefits of agents targeting related biological pathways...