What is Network Meta-Analysis (NMA)?

in ,

These comparisons create a web-like analysis called a Network Diagram or Network Comparison. Other names of NMA include Multiple Treatment Meta-Analysis, Mixed Treatments Comparison, Indirect Treatment Comparison, Pair-Wise Meta-Analysis and so forth. NMA has been widely used in technology appraisals for various clinical indications by technology assessment agencies around the world. For instance, in January 2019, the FDA performed a fixed-effect network meta-analysis to investigate risk of MACE associated with Romosozumab treatment. Read more

The Sentinel System for Industrial Use: Strengths and Weaknesses

in

Currently, the Sentinel Distributed Database (SDD) is comprised largely of administrative and claims data from health insurers. These large administrative claims databases have become increasingly popular sources of data for comparative safety research (observational studies) because they have several important strengths including a large size, longitudinal data on prescription drug use, generalizability, and low operational costs. Read more

Using the Sentinel System in FDA Submissions

in

Recently, FDA has been using RWD from Sentinel System (SS) in drug approval process quite often to evaluate some safety signals in the postmarket setting and also for other purpose.

For past three advisory committee meetings hold in January 2019, SS has been applied in two approval processes (Jan 11 and Jan 17 , 2019) and one (Jan 16, 2019) in proposing potential possibility to use SS database in post-marketing safety study. Read more

What is the FDA’s Sentinel System (SS)?

in

Starting with a mini-sentinel pilot program, the Sentinel initiative began in 2008 as a multi-year effort to create a national electronic system for monitoring the performance of FDA-regulated medical products. Working with public, academic, and private entities, the FDA developed the sentinel system and launched in 2016. The Sentinel System obtains information from existing electronic healthcare data from multiple sources to assess the safety of approved medical products. The efforts of integrating the Sentinel System into the FDA’s regulatory programs enables the administration to evaluate some safety signals in the postmarket setting more effectively by using Sentinel’s automated tools. Read more