892. Cost Drivers of Hospital Acquired Bacterial Pneumonia and Ventilator Associated Bacterial Pneumonia (HABP/VABP) Phase Three Clinical Trials
Session: Poster Abstract Session: Clinical Trials
Friday, October 9, 2015
Room: Poster Hall
Posters
  • Final CTTI Poster - ID Week (002).pdf (82.3 kB)
  • Background: Studies indicate that the prevalence rate of hospital acquired and ventilator associated bacterial pneumonia (HABP/VABP) -- conditions that are very challenging and expensive to manage -- has been rising. There are many challenges associated with clinical trials targeting this disease area due to the variety of pathogens.  HABP/VABP clinical trials are very costly to conduct given protocol complexities and difficulty recruiting and retaining patients.  A new study conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) and the Clinical Trials Transformation Initiative at Duke University (CTTI) evaluates the drivers of HABP/VABP direct and indirect clinical trial costs and identifies opportunities to lower these costs.

    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.

    Stella Stergiopoulos, BA1, Pamela Tenaerts, MD2, Kenneth Getz, MBA1, Carrie Brown, MS3, Josephine Awatin, BS1, Sara Calvert, PhD4 and Joseph Dimasi, PhD1, (1)Tufts Center for the Study of Drug Development, Boston, MA, (2)Clinical Trials Transformation Initiative, Durham, NC, (3)Tufts University, Boston, MA, (4)Clinical Trials Transformation Initiative (CTTI), Duke University, Durham, NC

    Disclosures:

    S. Stergiopoulos, None

    P. Tenaerts, None

    K. Getz, None

    C. Brown, None

    J. Awatin, None

    S. Calvert, None

    J. Dimasi, None

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