I’m noting that FDA has posted new guidance on relaxing trial exclusion criteria, with an eye toward ‘representativeness’ and ‘generalizability’:
In oncology at least, it is often held that participation in a trial may confer benefits regardless of treatment assignment—due, e.g. to the quality of care inherent in trials. Thus, broader inclusiveness seems at the very least to promote equity. But what about the scientific and inferential benefits cited? Does any of the criticism one hears of ‘representativeness’ and ‘generalizability’ apply in this case?