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.
Women in the UK with the studied rare diseases (i.e., rare CTDs, rare neurological diseases,
brain cancer, cervical/vulvar cancer and lymphoma) as cases and women in the UK without any of the 5 studied rare diseases as controls.
For each of the 5 case-control studies, 1,500 cases of women diagnosed with each specific
studied rare disease will be identified from the GPRD. A total of 4000 women identified from the GPRD without any of the 5 rare disease outcomes will be enrolled as a control group to the 5 case groups.
Patient data will be collected from three sources: the GPRD database, directly from the patient
via a structured questionnaire, and if the patient had silicone breast implants, directly from the surgeon who performed the implantation procedure. The study data will be entered into an electronic data capture system (EDC) using an electronic case report form (eCRF). Available data will be abstracted from the GPRD database and entered into the eCRF. The de-identified completed patient questionnaires will also be entered into the EDC. For patients who had breast implants, the surgeon who performed the implantation procedure will be contacted directly to obtain the data on the manufacturer and style of silicone breast implant.
Information obtained from both the cases and controls will include the following:
¿ Data collected from the GPRD database will include date of birth, date at diagnosis (all cases), date of identification from database (controls), socioeconomic status (census area-level based on post code), history of breast cancer, history of oral contraceptive use, tobacco use history, body mass index (BMI), number of live births, age at first pregnancy, age at first live birth
¿ Data collected from the patient will include ethnicity, for cases family history of the studied rare disease (cases), for controls family history of any of the five studied rare diseases, breast implant history (i.e., indication, type, shape, date of implantation, contact information of the surgeon), smoking history, alcohol use history, for controls sexual history
¿ Data collected from the surgeon (if patient had implants) will include date of implant, manufacturer of Implant, style of Implant
Cases will be identified among the diagnoses starting 2004 to allow about 10 years of exposure to the silicone breast implants from the GPRD database.
Followup Visits and Length of Followup
There is no prospective follow-up for case-control studies