Site image reviews using RECIST or Lugano criteria are often fraught with error rates reported between 10 and 40%. Relying on the consistency of blinded independent central review (BICR) of trial images to determine drug efficacy is well-established in oncology clinical development. These highly structured reviews provide reliable results for go/no go decisions in early phase, and in confirming response in later phase. However, often-overlooked areas of site read errors is in the correct determination of patient imaging eligibility or in disease progression. Site image interpretation errors in either can result in patient censoring and increased trial costs, ethical issues, and potential medicolegal liability concerns.
Our White Paper clearly provides the rationales for both the risk benefits and cost savings BICR for imaging eligibility and to confirm disease progression. Don’t let site read errors inflate your trial costs and muddy your imaging data results.