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 #
5P30CA134274-06
Application #
8545699
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2013-08-01
Budget End
2014-07-31
Support Year
6
Fiscal Year
2013
Total Cost
$66,902
Indirect Cost
$28,336
Name
University of Maryland Baltimore
Department
Type
DUNS #
188435911
City
Baltimore
State
MD
Country
United States
Zip Code
21201
Wang, Junxiang; Zhao, Liang; Ye, Yanfang et al. (2018) Adverse event detection by integrating twitter data and VAERS. J Biomed Semantics 9:19
Furusawa, Aki; Reiser, John; Sadashivaiah, Kavitha et al. (2018) Eomesodermin Increases Survival and IL-2 Responsiveness of Tumor-specific CD8+ T Cells in an Adoptive Transfer Model of Cancer Immunotherapy. J Immunother 41:53-63
Nathenson, Michael J; Conley, Anthony P; Sausville, Edward (2018) Immunotherapy: A New (and Old) Approach to Treatment of Soft Tissue and Bone Sarcomas. Oncologist 23:71-83
Wang, Lei; Felts, Sara J; Van Keulen, Virginia P et al. (2018) Exploring the effect of library preparation on RNA sequencing experiments. Genomics :
Nathenson, Michael J; Barysauskas, Constance M; Nathenson, Robert A et al. (2018) Surgical resection for recurrent retroperitoneal leiomyosarcoma and liposarcoma. World J Surg Oncol 16:203
Sallmyr, Annahita; Tomkinson, Alan E (2018) Repair of DNA double-strand breaks by mammalian alternative end-joining pathways. J Biol Chem 293:10536-10546
Kerr, Candace; Adhikary, Gautam; Grun, Daniel et al. (2018) Combination cisplatin and sulforaphane treatment reduces proliferation, invasion, and tumor formation in epidermal squamous cell carcinoma. Mol Carcinog 57:3-11
Connolly, Sean; Quasi-Woode, Devona; Waldron, Laura et al. (2018) Calcineurin Regulatory Subunit Calcium-Binding Domains Differentially Contribute to Calcineurin Signaling in Saccharomyces cerevisiae. Genetics 209:801-813
Pauza, C David; Liou, Mei-Ling; Lahusen, Tyler et al. (2018) Gamma Delta T Cell Therapy for Cancer: It Is Good to be Local. Front Immunol 9:1305
Wang, Lei; Felts, Sara J; Van Keulen, Virginia P et al. (2018) Integrative Genome-Wide Analysis of Long Noncoding RNAs in Diverse Immune Cell Types of Melanoma Patients. Cancer Res 78:4411-4423

Showing the most recent 10 out of 257 publications