In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
The study is a prospective, non-randomized open-label concurrent control study of NovoTTF-100A in recurrent GBM
patients. A prospective, international, multi-center study, will include 30 centers in the US, EU and Israel, at least 15 centers in the US.
The study will include 2 groups: an Investigational Group composed of patients treated with the NovoTTF-100A and a Control Group of concurrent best standard of care chemotherapy.
Patients in the NovoTTF-100A group will be treated continuously until disease progression and then followed by telephone interview until death. Minimal recommended treatment duration is 4 weeks and minimal recommended treatment compliance is 18h/day (monthly average).
Study Population Description
The NovoTTF-100A System is intended as a treatment for adult
patients (22 years of age or
older) with histologically-confirmed
glioblastoma multiforme (GBM), following histologically- or
radiologically-confirmed recurrence in the supra-tentorial
region of the brain after receiving chemotherapy.
NovoTTF-100A Group
¿ Patients treated with the NovoTTF-100A
¿ Patients will be treated continuously until disease
