Impact of FDA's Regulatory Actions and Interventions
These assessments examine the impact of FDA's regulatory actions and interventions (e.g., black-box warnings) on selected outcomes such as physician prescribing patterns. These assessments typically involve development of study protocols. They use a variety of study designs and statistical methods.
- Modular program based one-time assessments. These assessments provide rapid response by making use of adaptable standardized programs ("modular programs"). These assessments can provide stratified results by age group, sex, and calendar year.
- Protocol based one-time assessments. These assessments use customized study designs and protocols that allow 1) detailed specification of exposure groups and health events, 2) adjustment for a range of potential confounding factors, and 3) comparison of event rates between different medical products. They may use a variety of study designs and statistical methods.
- Protocol based repeated assessments. These assessments involve repeated evaluation of information as it accrues within the Mini-Sentinel Distributed Dataset. They use customized study designs and protocols that allow 1) detailed specification of exposure groups and health events, 2) adjustment for a range of potential confounding factors, and 3) comparison of event rates between different medical products. They may use a variety of study designs and statistical methods, including sequential methods.
Disclaimer
The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from the Mini-Sentinel pilot in the public domain as soon as possible. Please read the disclaimer.