The Protocol Review and Monitoring System at the Rutgers Cancer Institute of New Jersey (CINJ) consists of the Scientific Review Board (SRB) and the Human Research Oversight Committee (HROC) that work collaboratively to provide oversight of all aspects of clinical research at the Center. The SRB focuses on the scientific merit, scientific priorities and ongoing scientific progress of CINJ clinical research. To provide the necessary expertise in the principal disciplines of oncology, the SRB consists of clinical, basic, and population scientists, biostatisticians, and a patient advocate. The SRB reviews all cancer-related clinical protocols before the Institutional Review Board (IRB) review, provides a centralized mechanism for evaluating scientific merit of all cancer clinical trials and prioritizes studies for access to CINJ resources. In addition, the committee reviews the adequacy of the CINJ Data and Safety Monitoring Plan (DSMP) and assigns level of risk to interventional investigator-initiated trials (IITs). The SRB works with HROC, which is an independent committee responsible for the safety review, accrual and study progress monitoring of all CINJ IITs. All DSMP activities fall under the purview of this committee and are further described in the Clinical Protocol and Data Management section. While the HROC is a distinct independent committee, HROC shares its findings and recommendations with the SRB, in the event that these are believed by the HROC to be potentially relevant to the scientific integrity of the trial. SRB reviews these findings and recommendations and has the authority to close any trials that are not meeting accrual or performance standards. Importantly, in the event that the committee is notified of misconduct or other issues, the SRB will contact all appropriate authorities (IRB, FDA, NCI, funding sponsor, etc.) as needed. It is of critical importance that CINJ have a mechanism for ensuring internal oversight of the scientific aspects of all cancer clinical trials of the consortium, complementary to the IRB.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA072720-20
Application #
9632912
Study Section
Subcommittee I - Transistion to Independence (NCI)
Project Start
Project End
Budget Start
2019-03-01
Budget End
2020-02-29
Support Year
20
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Rbhs -Cancer Institute of New Jersey
Department
Type
DUNS #
078728091
City
New Brunswick
State
NJ
Country
United States
Zip Code
08901
Zhu, Sining; Jin, Juan; Gokhale, Samantha et al. (2018) Genetic Alterations of TRAF Proteins in Human Cancers. Front Immunol 9:2111
Perekatt, Ansu O; Shah, Pooja P; Cheung, Shannon et al. (2018) SMAD4 Suppresses WNT-Driven Dedifferentiation and Oncogenesis in the Differentiated Gut Epithelium. Cancer Res 78:4878-4890
Llanos, Adana A M; Tsui, Jennifer; Rotter, David et al. (2018) Factors associated with high-risk human papillomavirus test utilization and infection: a population-based study of uninsured and underinsured women. BMC Womens Health 18:162
Hadigol, Mohammad; Khiabanian, Hossein (2018) MERIT reveals the impact of genomic context on sequencing error rate in ultra-deep applications. BMC Bioinformatics 19:219
Severson, Eric A; Riedlinger, Gregory M; Connelly, Caitlin F et al. (2018) Detection of clonal hematopoiesis of indeterminate potential in clinical sequencing of solid tumor specimens. Blood 131:2501-2505
Shih, Weichung Joe; Lin, Yong (2018) Relative efficiency of precision medicine designs for clinical trials with predictive biomarkers. Stat Med 37:687-709
Ding, Qiang; Gaska, Jenna M; Douam, Florian et al. (2018) Species-specific disruption of STING-dependent antiviral cellular defenses by the Zika virus NS2B3 protease. Proc Natl Acad Sci U S A 115:E6310-E6318
Winer, Benjamin Y; Shirvani-Dastgerdi, Elham; Bram, Yaron et al. (2018) Preclinical assessment of antiviral combination therapy in a genetically humanized mouse model for hepatitis delta virus infection. Sci Transl Med 10:
Modi, Parth K; Wang, Ye; Kirk, Peter S et al. (2018) The Receipt of Industry Payments is Associated With Prescribing Promoted Alpha-blockers and Overactive Bladder Medications. Urology 117:50-56
Dai, Zhuqing; Feng, Simin; Liu, Anna et al. (2018) Anti-inflammatory effects of newly synthesized ?-galacto-oligosaccharides on dextran sulfate sodium-induced colitis in C57BL/6J mice. Food Res Int 109:350-357

Showing the most recent 10 out of 775 publications