C-Path finalizes FDA partnership, announces new project
Summary:
Tucson's Critical Path Institute celebrated its first six months of operation with a ribbon-cutting ceremony on Dec. 10 and shows no sign of slowing down. The institute officially cemented its partnership with the U.S. Food and Drug Administration last week, and is about to begin one of its first drug safety studies in partnership with Bashas' pharmacies. The program will track patients on two drugs that treat lung disease, testing a potential model for new drug safety monitoring systems.
Full Story:
Tucson's Critical Path Institute celebrated its first six months of operation with a ribbon-cutting ceremony on Dec. 10.
In the days since the ribbon cutting ceremony, C-Path has made significant strides in becoming a premier institution that works to accelerate safely the drug development process. Last week the institute's partnership with the U.S. Food and Drug Administration became official.
It is the FDA's first public-private partnership created solely to fulfill the mission of the Critical Path Initiative, from which C-Path drew its name. The Critical Path Initiative is an FDA program that aims to improve the efficiency and safety of medical product development.
C-Path is also about to begin one of its first drug safety studies in partnership with Bashas'. The program will track patients on two drugs that treat lung disease. One drug, Atrovent, was approved by the FDA ten years ago. The second drug, Spiriva, was approved in 2004.
Every Bashas' pharmacy will hand out fliers that explain the program to customers filling prescriptions for Atrovent or Spiriva. Those who choose to participate will need to submit to an initial phone interview and sign a federally required disclosure form. All information will be confidential.
Patients will then be asked to report all side effects, good or bad, to the Arizona Poison Control Center within 30 days. They will be called for a follow-up interview at the end of the monitoring period. Bashas' is awarding $20 gift cards to every participant.
Ray Woosley, founder of C-Path, told the Arizona Daily Star that the initial goal of the study is to monitor 50 patients taking the lung drugs and then add two drugs per month to the study.
The program will test a potential model for new drug safety monitoring systems, and the hope is to expand it to major pharmacy chains, Woosley told the Star.
Lisa Higgins, assistant director for SafePath, one of C-Path's four program areas, told the Star that the program is being funded with $100,000 from the Agency for Healthcare Research and Quality, part of the U.S. Department of Health and Human Services.
For more information:
"Bashas', C-Path join FDA study," Arizona Daily Star, 12/15/2005
"New drugs' side effects monitored here," Tucson Citizen, 12/13/2005
Cowboy spirit inspires C-Path director, 08/19/2005