The objective of the Clinical Protocol and Data Management (CPDM) Shared Facility is to provide central management for the implementation, coordination, and conduct of UAB Cancer Center clinical trials developed by the UAB Cancer Center faculty and by extramural collaborators associated with SPOREs, other Cancer Centers, the NCI, private foundations, cooperative groups and industry. The CPDM accomplishes this objective by providing critical infrastructure to support the monitoring of trials, including all major aspects of quality assurance, and by providing a centralized database of protocol-specific data. CPDM adds value to the work of Cancer Center members by providing knowledgeable and professional support for investigators at all stages of experience with the clinical trials process. This robust infrastructure assures that all trials have excellent support in regulatory compliance, protocol adherence, and recruitment, especially minority recruitment. Demonstration of the quality of this shared resource can be seen through a number of objective measures. A recent audit showed UAB as """"""""outstanding"""""""" in protocol adherence. Patient enrollment has increased, especially to investigator-initiated trials, and our minority enrollment is in larger proportion to our surrounding population. The CPDM has taken steps to improve the infrastructure, largely in response to the changes in faculty and research emphasis over the past five years, but also in response to the changing regulatory environment. The CPDM has worked with other parts of the center to implement OnCore, a comprehensive clinical and translational research management software. The CPDM has implemented a Clinical Trials Monitoring Committee to monitor active clinical trials in the Cancer Center at least monthly for safety and progress. The faculty also incorporated specialized Protocol Management Teams who have enhanced both nurse-physician interaction and accrual to trials in high-priority areas. n summary, the CPDM has expanded its capacities and aligned its focus with the changing needs of UAB Comprehensive Cancer Canter members, and continues to provide excellent coordinating and monitoring support.

Public Health Relevance

Clinical trials need to be conducted so that the safety of participants in the trial is closely monitored, and so that the trials yield reliable data. The CPDM Shared Facility is an integral component of the CCC that supports the entire spectrum of UAB clinical research in cancer patients ranging from the pilot and phase 0 trials, to the early (Phase I and II) and late phase studies (Phase III and IV). It is a well organized facility that supports clinical investigators translate research into viable treatment, from development to completion of clinical studies.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA013148-42
Application #
8738177
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2014-04-01
Budget End
2015-03-31
Support Year
42
Fiscal Year
2014
Total Cost
$363,843
Indirect Cost
$63,251
Name
University of Alabama Birmingham
Department
Type
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294
Subramaniam, Akila; Blanchard, Christina T; Erickson, Britt K et al. (2018) Feasibility of Complete Salpingectomy Compared With Standard Postpartum Tubal Ligation at Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol 132:20-27
Kasten, Benjamin B; Oliver, Patsy G; Kim, Harrison et al. (2018) 212Pb-Labeled Antibody 225.28 Targeted to Chondroitin Sulfate Proteoglycan 4 for Triple-Negative Breast Cancer Therapy in Mouse Models. Int J Mol Sci 19:
Stoll, Matthew L; Weiss, Pamela F; Weiss, Jennifer E et al. (2018) Age and fecal microbial strain-specific differences in patients with spondyloarthritis. Arthritis Res Ther 20:14
Garner, Evan F; Williams, Adele P; Stafman, Laura L et al. (2018) FTY720 Decreases Tumorigenesis in Group 3 Medulloblastoma Patient-Derived Xenografts. Sci Rep 8:6913
Locke, Landon W; Kothandaraman, Shankaran; Tweedle, Michael et al. (2018) Use of a leukocyte-targeted peptide probe as a potential tracer for imaging the tuberculosis granuloma. Tuberculosis (Edinb) 108:201-210
Fancy, Romone M; Kim, Harrison; Napier, Tiara et al. (2018) Calmodulin antagonist enhances DR5-mediated apoptotic signaling in TRA-8 resistant triple negative breast cancer cells. J Cell Biochem 119:6216-6230
Barrington, David A; Champion, Macie L; Boitano, Teresa K L et al. (2018) Characteristics of African American women at high-risk for ovarian cancer in the southeast: Results from a Gynecologic Cancer Risk Assessment Clinic. Gynecol Oncol 149:337-340
Banerjee, N Sanjib; Wang, Hsu-Kun; Beadle, James R et al. (2018) Evaluation of ODE-Bn-PMEG, an acyclic nucleoside phosphonate prodrug, as an antiviral against productive HPV infection in 3D organotypic epithelial cultures. Antiviral Res 150:164-173
Keene, Kimberly S; King, Tari; Hwang, E Shelley et al. (2018) Molecular determinants of post-mastectomy breast cancer recurrence. NPJ Breast Cancer 4:34
Kleinpeter, Alex B; Jureka, Alexander S; Falahat, Sally M et al. (2018) Structural analyses reveal the mechanism of inhibition of influenza virus NS1 by two antiviral compounds. J Biol Chem 293:14659-14668

Showing the most recent 10 out of 747 publications