Accession Number:

ADA426925

Title:

UAB - Community Breast Cancer Network

Descriptive Note:

Final rept. 15 Jun 2000-14 Jun 2004

Corporate Author:

ALABAMA UNIV IN BIRMINGHAM

Personal Author(s):

Report Date:

2004-07-01

Pagination or Media Count:

11.0

Abstract:

The University of Alabama at Birmingham UAB Clinical Trial Network was formed with the aim of establishing a clinical research consortium between the UAB Comprehensive Cancer Center UAB CCC, community-based oncology practices, and pharmaceutical sponsors, which would provide access to high priority breast cancer clinical trials to women in the community. The Department of Defense DoD grant provided funding to establish the network infrastructure followed by the activation of breast cancer clinical trials in the community. This was the first time ever implementation of this funding mechanism. Year 2001 was primarily dedicated to establishment of the network infrastructure and development of a working relationship between the network and funding organization as well as the Human Subjects Research Review Board HSRRB in regards to protocol approval and activation. Six clinical trials were activated in Year 2002 and accrued a total of 69 patients. Clinical trials at the network sites were put on hold in Year 2003 following an Food and Drug Administration FDA audit of a non-network trial revealed deficiency in protocol compliance and Good Clinical Practice GCP. A non-funded extension was approved for Year 04. A total of 121 patients were accrued at the network sites during the landing period and currently three protocols are actively accruing patients. The major accomplishments during the granting period included establishment of a successful clinical trials network that provided access to women in the community to cutting edge clinical trials. While the FDA-mandated clinical hold resulted in a substantial setback to the momentum of the network activity and a disruption of the proposed clinical research efforts, with the assistance of the academic partner retraining and reorientation, the network sites successfully established a self-sustaining clinical research program and recently successfully passed an FDA audit.

Subject Categories:

  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE