Protocol-Specific Research Support (PSRS) Innovative clinical research, especially that tied to UMGCC basic research and involving pilot or pre Phase I, or Phase I investigator-initiated trials testing clinical interventions with a candidate agent or device for the diagnosis, prevention, detection, or treatment of cancer may be eligible for Protocol Specific Research Support (PSRS). Such support will underwrite research coordinator activities and data management functions. Data from such research protocols can be used to support later phase activities with these interventions, or as a basis for acquiring funding from other sources to continue the piloted activities. This critical early support provided by PSRS, is necessary to move such trials forward, especially because per patient costs are not reimbursed. PSRS, utilizing recently revised (2008) guidelines from the National Cancer Institute (NCI) for its use, will support research coordinators and data managers at UMGCC to facilitate these innovative clinical investigation efforts. Trials supported by PSRS will be approved for such funding only after meeting additional criteria as judged by the Clinical Research Committee. The trials will be assigned a priority scale for funding based on how the protocol is, respectively, significant and innovative in promoting the development of a novel cancer diagnosis, treatment, imaging, or prevention strategy. Additional criteria include evidence that the proposed trial possesses correlative science that will be critically enabled as a result of PSRS funding, with translational collaborators and assays in place, and the use of PSRS funding will allow the development of independent or future funding vehicles for the research strategy. Five of 22 recently (CY2009) approved investigator-initiated trials in UMGCC's portfolio potentially qualify for the up to 1 year of research nurse and data manager support in accord with the new PSRS guidelines limiting the type of use and period of applicable PSRS funding. This support will give UMGCC the flexibility to advance the cause of high-priority, innovative, early phase clinical trials. These trials will have no or at best partial industry support, excluding per-patient costs. Ideally, PSRS-supported studies would flow from investigator initiated clinical research, or would be the logical consequence of an alliance between basic scientists at UMGCC and clinicians who are suitable for addressing a translational science goal that is not incorporated into other grant-supported trials of NCI or other funding agencies.

Public Health Relevance

PSRS is instrumental in launching pilot or Phase I investigator-initiated trials and will help bridge support for these trials as other support is being defined or allow completion in its own right of pilot trials. This activity is essential in the role of UMGCC as a catalyst of innovative investigator-initiated proposals tied to science to reach the clinic in a rapid fashion, in support of the defining mission of the NCI Cancer Center Support Grant.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA134274-04
Application #
8340252
Study Section
Subcommittee G - Education (NCI)
Project Start
2011-08-24
Project End
2016-07-31
Budget Start
2011-08-24
Budget End
2012-07-31
Support Year
4
Fiscal Year
2011
Total Cost
$71,239
Indirect Cost
Name
University of Maryland Baltimore
Department
Type
DUNS #
188435911
City
Baltimore
State
MD
Country
United States
Zip Code
21201
Wang, Lei; Ma, Xiao; Xu, Xiaolei et al. (2017) Systematic identification and characterization of cardiac long intergenic noncoding RNAs in zebrafish. Sci Rep 7:1250
Nowak, Rebecca G; Ambulos, Nicholas P; Schumaker, Lisa M et al. (2017) Genotyping of high-risk anal human papillomavirus (HPV): ion torrent-next generation sequencing vs. linear array. Virol J 14:112
Thomas, Stefani N; Yang, Austin J (2017) Mass Spectrometry Analysis of Lysine Posttranslational Modifications of Tau Protein from Alzheimer's Disease Brain. Methods Mol Biol 1523:161-177
Kaczanowska, Sabina; Joseph, Ann Mary; Guo, Jitao et al. (2017) A Synthetic CD8?:MyD88 Coreceptor Enhances CD8+ T-cell Responses to Weakly Immunogenic and Lowly Expressed Tumor Antigens. Cancer Res 77:7049-7058
Larrosa-Garcia, Maria; Baer, Maria R (2017) FLT3 Inhibitors in Acute Myeloid Leukemia: Current Status and Future Directions. Mol Cancer Ther 16:991-1001
Stick, Line B; Yu, Jen; Maraldo, Maja V et al. (2017) Joint Estimation of Cardiac Toxicity and Recurrence Risks After Comprehensive Nodal Photon Versus Proton Therapy for Breast Cancer. Int J Radiat Oncol Biol Phys 97:754-761
Connolly, Nina P; Stokum, Jesse A; Schneider, Craig S et al. (2017) Genetically engineered rat gliomas: PDGF-driven tumor initiation and progression in tv-a transgenic rats recreate key features of human brain cancer. PLoS One 12:e0174557
Carter-Cooper, Brandon A; Fletcher, Steven; Ferraris, Dana et al. (2017) Synthesis, characterization and antineoplastic activity of bis-aziridinyl dimeric naphthoquinone - A novel class of compounds with potent activity against acute myeloid leukemia cells. Bioorg Med Chem Lett 27:6-10
Young, Christina A; Rorke, Ellen A; Adhikary, Gautam et al. (2017) Loss of epidermal AP1 transcription factor function reduces filaggrin level, alters chemokine expression and produces an ichthyosis-related phenotype. Cell Death Dis 8:e2840
Nowak, Rebecca G; Bentzen, Søren M; Ravel, Jacques et al. (2017) Rectal microbiota among HIV-uninfected, untreated HIV, and treated HIV-infected in Nigeria. AIDS 31:857-862

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