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.
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.
|Nebane, N Miranda; Coric, Tatjana; McKellip, Sara et al. (2016) Acoustic Droplet Ejection Technology and Its Application in High-Throughput RNA Interference Screening. J Lab Autom 21:198-203|
|Zhang, Wei; Zhai, Ling; Wang, Yimin et al. (2016) Discovery of a novel inhibitor of kinesin-like protein KIFC1. Biochem J 473:1027-35|
|Carvajal, Felipe; Vallejos, Maricarmen; Walters, Beth et al. (2016) Structural domains within the HIV-1 mRNA and the ribosomal protein S25 influence cap-independent translation initiation. FEBS J 283:2508-27|
|Badiga, Suguna; Chambers, Michelle M; Huh, Warner et al. (2016) Expression of p16(INK4A) in cervical precancerous lesions is unlikely to be preventable by human papillomavirus vaccines. Cancer 122:3615-3623|
|Zhang, Wei; Zhai, Ling; Lu, Wenyan et al. (2016) Discovery of Novel Allosteric Eg5 Inhibitors Through Structure-Based Virtual Screening. Chem Biol Drug Des 88:178-87|
|Hull, Travis D; Boddu, Ravindra; Guo, Lingling et al. (2016) Heme oxygenase-1 regulates mitochondrial quality control in the heart. JCI Insight 1:e85817|
|Hegde, Shylaja; Kesterson, Robert A; Srivastava, Om P (2016) CRYÎ²A3/A1-Crystallin Knockout Develops Nuclear Cataract and Causes Impaired Lysosomal Cargo Clearance and Calpain Activation. PLoS One 11:e0149027|
|Smith, M Ryan; Vayalil, Praveen K; Zhou, Fen et al. (2016) Mitochondrial thiol modification by a targeted electrophile inhibits metabolism in breast adenocarcinoma cells by inhibiting enzyme activity and protein levels. Redox Biol 8:136-48|
|McNally, Lacey R; Mezera, Megan; Morgan, Desiree E et al. (2016) Current and Emerging Clinical Applications of Multispectral Optoacoustic Tomography (MSOT) in Oncology. Clin Cancer Res 22:3432-9|
|Styles, Nathan A; Shonsey, Erin M; Falany, Josie L et al. (2016) Carboxy-terminal mutations of bile acid CoA:N-acyltransferase alter activity and substrate specificity. J Lipid Res 57:1133-43|
Showing the most recent 10 out of 566 publications