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Project Title:
ICOS PAFASE Trial
Funding Agency:
ICOS Inc.
Total Project Period:
Jun 01, 2002 - May 31, 2006
Principal Investigator:
Derek Angus, MD
Project Summary:
ICOS Corporation (ICOS) is conducting a phase III clinical trial (BAR03) to evaluate the efficacy and safety of recombinant Platelet Activating Factor Acetylhydrolase (Pafase) in patients with severe sepsis and/or septic shock. ICOS wishes to assess the impact of Pafase on extended patient outcomes and costs concurrently with this phase III trial -- in other words, to assess the health economics of Pafase in severe sepsis.
The CRISMA Laboratory will coordinate the Health Economics Sub-study and directly perform the collection of billing data and the final economic analyses. ICOS and its agents will provide CRISMA with other clinical and resource use data.
CRISMA will execute a state-of-the-art analytic and modeling plan that will provide a detailed assessment in keeping with current and pending guidelines for the conduct and reporting of health economic studies. The specific aims of this health economics sub-study will be achieved by augmenting BAR03 data collection with detailed information on hospital costs, extended survival follow-up for a minimum of seven months, and patient interviews at discharge and at 7 months post enrollment to determine quality of life and resource use. We will also construct a micro-simulation model calibrated by results from BAR03 and published data on life-expectancy and costs and then adjusted to reflect a broader patient case-mix in routine clinical practice.
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