UAB-Community Breast Cancer Network
Abstract
The UAB Clinical Trial Network was aimed at forming a collaborative linkage between the UAB Comprehensive Cancer Center, community-based oncology practices and pharmaceutical sponsors, in order to provide access to high priority novel clinical trials to women with breast cancer within the community. Year O3 was dedicated to review of the Network activity by both the internal and external advisory board, which recommended modification of Network administrative and regulatory oversight activity. A thorough re-orientation and re-training of the research department at Georgia Cancer Specialists (GCS) was performed as part of a Corrective Action Plan following protocol adherence and compliance deficiencies noted during an FDA audit of a non-Network protocol. As a result, initiation of all new trials and patient accrual was voluntarily halted at GCS for 6 months, and then restarted in 2003 following successful passage of both an internal as well as external audit. Four Network breast cancer clinical trials active in Y02 completed accrual and have been closed. Total accrual from the Network sites was 49 for these trials . Following restart of patient accrual at GCS, two Network breast cancer trials were re-initiated and have accrued a total of 18 patients to date. Additional trials await initiation. Two clinical sites in Alabama have been added to our Network and activation of breast cancer trials at these sites is planned. We have received approval for a no-cost extension of funding into Year 04.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 01, 2003
- Accession Number
- ADA418380
Entities
People
- Albert Lobuglio
Organizations
- University of Alabama