Methods: Tufts CSDD gathered benchmark data from proprietary and commercial databases, as well as references cited from literature and created a model calculating a fully-loaded (direct and indirect) cost profile of a typical phase three HABP/VABP clinical trial. Tufts CSDD, in collaboration with CTTI developed a comprehensive, detailed mapping of direct and indirect cost elements. Cost elements mapped include direct procedure costs, institutional review board fees, site costs by geography, screen failure costs, and other indirect project management costs. Model results were validated by industry experts and published sources.
Results: Tufts CSDD determined the fully-loaded cost of a HABP/VABP phase three clinical trials. Key variables affecting the cost of a typical phase three HABP/VABP trial can be stratified as being related either to study scope (e.g. number of sites in a study, the geographic location of sites) or to study process (e.g. the cost of recruitment and screen fails). The cost of screen fails, as well as screen failure rates are the main drivers of cost for a phase III HABP/VABP trial.
Conclusion: Major opportunities to lower the high costs of HABP/VABP clinical trials — particularly new practices to lower screen failure rates — are discussed.
K. Getz, None
C. Brown, None
J. Awatin, None
S. Calvert, None
J. Dimasi, None