Treatment Patterns And Outcomes Of Patients Diagnosed With Ovarian Cancer In The Netherlands: A Registry Study.

ric cancers. Methods: Current oncology PIPs were manually extracted from the EMA website for the study period 2007-2014. Primary variables included: indication, applicant, decision, decision date, and date of expected completion. Indications for approved PIPs were classified into five categories: brain tumors, diagnostics, leukemias/lymphomas, side effects, and solid tumors. Results: A total of 105 PIPs were found; 36 of which were waivers, and 69 of which were approved. The study found that 39% (27) of approved PIPs were indicated for solid tumors, including melanomas and malignant tumors; 30% (21) of approved PIPs were indicated for leukemias or lymphomas; 17% (12) of approved PIPs were indicated for chemotherapy-induced side effects, such as anti-nausea and neuotropenia medications; 12% (8) of approved PIPs were indicated for brain tumors; and one oncology diagnostic PIP was also approved. The ramp-up of the PIP program was significant. PIPs approved in 2013 and the first half of 2014 accounted for 54% (37) of all PIPs approved during the study period. ConClusions: Approved PIPs covered a wide range of pediatric cancers, and the number of approved PIPs increased significantly over time. While the rampup of the PIP program indicated that it was successful in promoting research in this area, serious concerns remained regarding the feasibility of the program. For example, there were currently four trials planned for completion between 20152020 for extremely rare high grade gliomas. This limitation may compromise the integrity of the PIP program.