Drug Benefit Risk Analysis for BRAT Framework

Overview

Pharmaceutical product benefit-risk assessments play a critical role in bringing new treatments to market, providing information for decisions regarding drug development, licensing and reimbursement, and others.  In 2005, the Pharmaceutical Research and Manufacturers of America (PhRMA) formed the Benefit-Risk Action Team (BRAT) for the purpose of developing a structured, systematic and transparent approach to assessing the benefit-risk profile of pharmaceutical products, to be used in the context of regulatory or clinical decision-making and related endeavors. The result of the BRAT's efforts was the "PhRMA BRAT Framework for Benefit-Risk Assessment," commonly known as the "BRAT Framework".   

This application allows users to generate simplified tabular displays to assist in the interpretation of benefit and risk findings during the drug’s development, submission and post-approval phases. It coordinates the five phases of the BRAT framework from planning to conclusion and provides approval process flows for stakeholder review.   

• Displays value trees and key benefit-risk summary tables
• Provides stage based status and a dashboard view of a drug under analysis
• Provides a record all updates during the process , a complete Task Audit History of Drug Analysis
• Provides users with ability to add and update weightage to individual benefits and risks based on their expertise and past data
• Collects approvals and comments by routing the request via process to the appropriate approver