ABSTRACT
CONTENTS 34.1 Rising Expectations ........................................................................................................604
34.1.1 Increased Spending ..........................................................................................604 34.1.2 Reduced Review Time ......................................................................................604
34.2 Indicators of Drug Development Problems ................................................................605 34.2.1 Increasing Development Costs ........................................................................606 34.2.2 Increasing Failure Rate ....................................................................................606
34.3 Enhancing Systemic Understanding ............................................................................607 34.3.1 The Societal Challenge ......................................................................................607 34.3.2 Targeted Therapy ..............................................................................................608
34.4 Food and Drug Administration Diagnosis: The Critical Path to New Medicines 608 34.4.1 The Applied Science of Development ............................................................608 34.4.2 The Applied Science Gap ................................................................................609 34.4.3 Defining the Critical Path ................................................................................609 34.4.4 Explaining the Process ......................................................................................610
34.5 Collaborating to Improve the Critical Path ................................................................611 34.5.1 Generalizing and Sharing Knowledge ..........................................................611 34.5.2 Developing Enabling Standards ......................................................................611 34.5.3 Incorporating Proof-of-Mechanism Studies ..................................................612 34.5.4 Improving Clinical Trial Design ......................................................................612 34.5.5 Conducting Less-Expensive Trials ..................................................................612 34.5.6 Standardizing the Data ....................................................................................612 34.5.7 Agreeing on Clinical Trial Analyses ..............................................................613 34.5.8 Finding and Constructing Disease-Specific Endpoints ..............................613 34.5.9 Additional Drug Development Challenges ..................................................614 34.5.10 Rebuilding the Academic Base in Experimental Medicine ........................615
34.6 Discrete Critical Path Deliverables ..............................................................................615
