- PROTOCOL REVIEW AND MONITORING SYSTEM The Protocol Review and Monitoring System (PRMS) provides scientific oversight of all clinical and translational research performed at the Albert Einstein Cancer Center (AECC). PRMS functions are carried out by the Protocol Review and Monitoring Committee (PRMC), a multidisciplinary group whose members have expertise and experience in therapeutics, drug development, and translational science. The PRMC performs a complete scientific, feasibility, and administrative review of all institutional investigator-initiated and industry- sponsored cancer-related protocols. The PRMC does not duplicate traditional peer review, which includes peer-reviewed protocols supported by the various NIH mechanisms, other approved funding agencies, and clinical research protocols supported by NCI's Cancer Therapy Evaluation Program or Cancer Control Protocol Review Committee. All NCI-sponsored protocols that have undergone prior peer review undergo an expedited administrative review for feasibility and overlapping eligibility with other trials. Functions of the PRMC are complementary to the Institutional Review Board (IRB), which focuses on the protection of human subjects, and separate from those of the AECC Data Safety Monitoring Committee (DSMC). The PRMC ensures that all trials have appropriate data safety and monitoring plans in place; data and safety monitoring functions are the responsibility of the DSMC. The system for initial review comprises 2-stages, starting first with approval by a disease or modality-oriented clinical research leader (CRL) and Associate Director for Clinical Research, followed by review by the PRMC. This 2-stage review process increases efficiency by (i) reducing staff effort in developing protocols and PRMC application materials of lesser scientific merit, (ii) reducing the time from concept approval to protocol activation, and (iii) decreasing the volume of protocols reviewed by the committee. Over the last 3-years (7/1/15-6/30/18), there were 442 new protocols activated, including 306 intervention (15% institutional) and 136 non-intervention (85% institutional).

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA013330-47
Application #
9792765
Study Section
Subcommittee I - Transistion to Independence (NCI)
Project Start
Project End
Budget Start
2019-07-01
Budget End
2020-06-30
Support Year
47
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Albert Einstein College of Medicine
Department
Type
DUNS #
081266487
City
Bronx
State
NY
Country
United States
Zip Code
10461
Hayama, Ryo; Sparks, Samuel; Hecht, Lee M et al. (2018) Thermodynamic characterization of the multivalent interactions underlying rapid and selective translocation through the nuclear pore complex. J Biol Chem 293:4555-4563
Willis, Ian M; Moir, Robyn D; Hernandez, Nouria (2018) Metabolic programming a lean phenotype by deregulation of RNA polymerase III. Proc Natl Acad Sci U S A 115:12182-12187
Huang, Kezhen; Mukherjee, Subhajit; DesMarais, Vera et al. (2018) Targeting the PXR-TLR4 signaling pathway to reduce intestinal inflammation in an experimental model of necrotizing enterocolitis. Pediatr Res 83:1031-1040
Martynova, Elena; Bouchard, Maxime; Musil, Linda S et al. (2018) Identification of Novel Gata3 Distal Enhancers Active in Mouse Embryonic Lens. Dev Dyn 247:1186-1198
Mathew, Deepti; Wang, Yanhua; Van Arsdale, Anne et al. (2018) Expression of ?V-Tubulin in Secretory Cells of the Fallopian Tube Epithelium Marks Cellular Atypia. Int J Gynecol Cancer 28:363-370
Bines, Jose; Tevaarwerk, Amye J (2018) Baby steps: Pregnancy outcomes after human epidermal growth factor receptor 2-targeted therapy. Cancer :
Entenberg, David; Voiculescu, Sonia; Guo, Peng et al. (2018) A permanent window for the murine lung enables high-resolution imaging of cancer metastasis. Nat Methods 15:73-80
Mao, Kai; Quipildor, Gabriela Farias; Tabrizian, Tahmineh et al. (2018) Late-life targeting of the IGF-1 receptor improves healthspan and lifespan in female mice. Nat Commun 9:2394
Sharma, Yogeshwar; Liu, Jinghua; Kristian, Kathleen E et al. (2018) In Atp7b-/- Mice Modeling Wilson's Disease Liver Repopulation with Bone Marrowderived Myofibroblasts or Inflammatory Cells and not Hepatocytes is Deleterious. Gene Expr :
Iqbal, Niloy Jafar; Lu, Zhonglei; Liu, Shun Mei et al. (2018) Cyclin-dependent kinase 4 is a preclinical target for diet-induced obesity. JCI Insight 3:

Showing the most recent 10 out of 1508 publications