Protocol Review and Monitoring System Principal Investigator: Pestell, Richard G., M.D., Ph.D. (P30 CA056036) PROJECT SUMMARY (See Instructions): PROTOCOL REVIEW AND MONITORING SYSTEM The Protocol Review and Monitoring System (PRMS) of the Kimmel Cancer Center (KCC) is an integral component of the KCC clinical investigations activities. The KCC PRMS is named the Cancer Clinical Research Review Committee (CCRRC). The CCRRC reviews all new research proposals involving human subjects and neoplastic diseases. Protocols receive a first review by the pertinent Multidisciplinary Disease Group, which provides a written evaluation of protocol feasibility, lack of competitive protocols or stratification if overlap with other protocols exists, and compatibility with KCC research and accrual goals. This evaluation is signed off by the specific Multidisciplinary Disease Group Leader. The Clinical Research Management Office (CRMO) staff prepares the documentation and coordinates meetings and communications for the CCRRC.
The specific aims of the CCRRC are: (1) to maintain a review committee of Kimmel Cancer Center investigators (with representation from basic science and clinical areas) responsible for the initial scientific review and monitoring of all ongoing clinical trials;(2) to evaluate the scientific merit of new proposals (study value, methods, statistical merit, investigator experience, and patient resources);(3) to establish criteria for the prioritization of competing Kimmel Cancer Center studies;(4) to monitor trials for patient accrual metrics;(5) to maintain a collaborative relationship with the Thomas Jefferson University Institutional Review Board and the Kimmel Cancer Center Data and Safety Monitoring Committee (DSMC) to facilitate interaction between the three review committees;and (6) to assure protocol compliance through the monitoring of ongoing review scientific progress. The CCRRC initial scientific review of each proposed study focuses on: (1) study value;(2) methods;(3) investigator(s) experience (4) risk and (5) data and safety monitoring plans.
|McNair, Christopher; Xu, Kexin; Mandigo, Amy C et al. (2018) Differential impact of RB status on E2F1 reprogramming in human cancer. J Clin Invest 128:341-358|
|Garcia, Samantha A; Lebrun, Aurore; Kean, Rhonda B et al. (2018) Clearance of attenuated rabies virus from brain tissues is required for long-term protection against CNS challenge with a pathogenic variant. J Neurovirol 24:606-615|
|Vido, Michael J; Le, Kaitlyn; Hartsough, Edward J et al. (2018) BRAF Splice Variant Resistance to RAF Inhibitor Requires Enhanced MEK Association. Cell Rep 25:1501-1510.e3|
|Brody, Jonathan R; Dixon, Dan A (2018) Complex HuR function in pancreatic cancer cells. Wiley Interdiscip Rev RNA 9:e1469|
|Liao, Lili; Liu, Zongzhi Z; Langbein, Lauren et al. (2018) Multiple tumor suppressors regulate a HIF-dependent negative feedback loop via ISGF3 in human clear cell renal cancer. Elife 7:|
|Heeke, Arielle L; Pishvaian, Michael J; Lynce, Filipa et al. (2018) Prevalence of Homologous Recombination-Related Gene Mutations Across Multiple Cancer Types. JCO Precis Oncol 2018:|
|Parent, Kristin N; Schrad, Jason R; Cingolani, Gino (2018) Breaking Symmetry in Viral Icosahedral Capsids as Seen through the Lenses of X-ray Crystallography and Cryo-Electron Microscopy. Viruses 10:|
|Rappaport, Jeffrey A; Waldman, Scott A (2018) The Guanylate Cyclase C-cGMP Signaling Axis Opposes Intestinal Epithelial Injury and Neoplasia. Front Oncol 8:299|
|Pandya, Kalgi D; Palomo-Caturla, Isabel; Walker, Justin A et al. (2018) An Unmutated IgM Response to the Vi Polysaccharide of Salmonella Typhi Contributes to Protective Immunity in a Murine Model of Typhoid. J Immunol 200:4078-4084|
|Hussain, Maha; Daignault-Newton, Stephanie; Twardowski, Przemyslaw W et al. (2018) Targeting Androgen Receptor and DNA Repair in Metastatic Castration-Resistant Prostate Cancer: Results From NCI 9012. J Clin Oncol 36:991-999|
Showing the most recent 10 out of 807 publications