The FDA announced draft guidance introducing an optional submission process for determining the risks or non-risks of using an investigational in vitro diagnostic in a clinical trial involving an oncology investigational drug.
The submission process determines whether the use of an investigational IVD in a clinical trial for an oncology therapeutic is a significant risk, nonsignificant risk or exempt. The trial may require an investigational device exemption (IDE) approval if it is found to be a significant risk, the guidance stated, in addition to an investigational new drug (IND) application.
A single sponsor should be prepared to hold communications with the FDA about the IND, the guidance said, and should submit information about the oncology development program to either CBER or CDER, who will consult CDRH to determine its risk factor.
That information includes how the sponsor will apply investigational IVD results to the clinical trial, what they know about the prevalence of the biomarker in the patient population, and the specimen type that will be collected for investigational IVD testing, the guidance stated. In addition, if a biopsy is required for the IIVD testing, the sponsor should note any potential risks.
Read the draft guidance here: www.fdanews.com/04-13-18-InVitro.pdf. — James Miessler