Estimation of Cancer Progression Based Clinical Trial Subgroups

Abstract

Cancer trials often start investigational therapy at diagnosis or after a selected number of relapses. These are the usual core inclusion criteria in clinical trials. Hence it is helpful when planning a trial to know the likely percentages of patients receiving standard therapy at clinics and hospitals who meet this key inclusion criteria of being newly diagnosed during a period or having just had their first, second or third relapse during an anticipated enrollment time frame. Often regulatory agencies will have approvals tied to the use of a therapy in a relapsed context or in a newly diagnosed context. We provide details on calculations to help those in clinical trial operations make realistic assessments on the number of sites and likely enrollment at clinical trial sites, and the enrollment time frames that might be needed to complete planned total patient enrollment. The estimates complement site feasibility questionnaires which are often sent to gauge patient availability and site interest.