According to ClinicalTrials.gov, 3% (n=361) of all Phase 3 studies started from 2013 through 2017 terminated early. While that appears to be a relatively low rate, each of these instances represents millions to tens of millions of dollars in expenditure.
Highlighting the challenges with feasibility, incorporating Quality by Design (QbD) and other Quality Risk Management (QRM) processes can result in cost savings / avoidances of tens of millions of dollars or more per each terminated phase 3 study.
Business / Strategic Reasons
While some of this may represent evolving standard of care, Portfolio Management that includes efficient POS Assessment, measure(s) of ROI, and Resource Management can be used to define and manage an optimized portfolio aligned with an organization’s strategy, creating an efficient frontier.
Financial / Resources
Identifying and managing fungible resources, critical path activities, and understanding capacity and resource requirements is key to navigating both the expected and unexpected.
What do you think about the 3% Phase 3 study termination rate. Is that a statistic we as an industry should be proud of or does it represent a target for improvement?
Contributed by: Jeff Handen | Senior Consultant | TayganPoint Consulting Group | firstname.lastname@example.org | LinkedIn