– Many trials of investigational products are conducted in populations that are, for the most part, racially or ethically homogeneous, which makes it difficult to predict accurately the efficacy and safety of the products when they are administered to different populations. True or False
– The Orphan Drug Act enabled the FDA to promote research into, and approval and marketing, of otherwise unprofitable drugs needed to treat rare diseases. True or False
– One of the challenges facing international trials is that studies not only have to comply with local and national regulations, but also with international regulations or guidelines.