FDA Releases Clinical Trial Guidelines Taking into Account CNS Metastases
The Food and Drug Administration recently released new guidance informing sponsors of clinical trials on recommendations to trial designs for systemic oncologic treatments in individuals with central nervous system metastases. According to the new guidelines, researchers must consider leptomeningeal disease, end points, central nervous system assessment, prior therapies and patient population when designing clinical trials. The assessment of tumors is best done through magnetic resonance imaging (“MRI”) with gadolinium contrast. The agency recommends that the involvement of the central nervous system (“CNS”) not be assessed separately from other metastatic illnesses present in other parts of a patient’s body. It adds…