Images: Read On Site or Centrally and Independently?
Ann Neuer | December 14, 2009 | As clinical trial protocols call for more imaging of all types, a big controversy is brewing as to whether efficacy can be based on site evaluation of images, or if the images should be read centrally, by trained and independent professionals. Much of the brouhaha centers on oncology trials and whether sites are able to adequately identify "progression-free survival (PFS)", an image-based surrogate endpoint that indicates whether a patient's disease has progressed.
"Making this kind of determination requires training and consistent methodology in acquiring and interpreting the images," says radiologist Rick Patt, principal of RadMD, a provider of "blinded reader services" and consultants for implementing medical imaging endpoints in clinical trials. Blinded read is shorthand for blinded independent central review (BICR), the form of review advocated by the Food and Drug Administration for radiographic exams used in oncology studies when PFS is the primary endpoint.