Biomedical Research & Development

This report quantified the potential impacts of select clinical strategies on the cost, duration, and phase transition probability associated with therapeutic complex medical device development stages. The model used data from a variety of sources (public and non-public) and widely accepted economic methods.

This environmental scan, conducted from September 2016 – September 2021, examines the potential impacts of select strategies on the cost, duration, and phase transition probability associated with drug, preventive vaccine, and therapeutic complex medical device development stages.

The objective of this report is to assess the current landscape of federal and federally funded health care data relevant to PCOR and economic analysis to identify gaps for data stewards, researchers, and future collection efforts.

Despite the increasing investment and interest in drug development, the amount of time and resources needed to develop a new drug continues to rise. Biomarkers are an important tool with the potential to decrease the time, cost, and failure rate of drug development.

Contents Demonstrating Clinical Validity and Utility Demonstrating Value Reducing Health Disparities Educating and Engaging Providers and Consumers Using Databases to Build Eviden