FDA has published a guidance for industry on an optional streamlined submission process for determining whether investigational in vitro diagnostic in clinical trials for an oncology therapeutic is considered significant risk, nonsignificant risk, or exempt from investigational device exemption requirements.
How’s this for a paradox: The better cancer centers become at keeping patients alive, the more expensive cancer care becomes. This brutal tradeoff hits harder in rural areas, where the cancer burden is higher and the investigator and clinical trial representation is lower.
