? Protocol Review and Monitoring System The goal of the Abramson Cancer Center (ACC) Protocol Review and Monitoring System (PRMS) is to ensure scientific merit, priorities, and progress of cancer-related protocols. The ACC PRMS utilizes a first-stage review of protocols within disease- and discipline-focused Clinical Research Units (CRUs) and second-stage review by the adult and pediatric scientific protocol committees [Clinical Trials Scientific Review and Monitoring Committee (CTSRMC) and Pediatric Protocol Review and Monitoring Committee (PPRC)], respectively. The PPRC is based at Children?s Hospital of Philadelphia (CHOP) and oversees pediatric cancer protocols in accordance with the same ACC review guidelines and reports to the parent CTSRMC. These functions are coordinated by Dr. Roger Cohen, the Associate Director for Clinical Research, and Dr. Victoria Salle, the Director of the ACC Department of Operations, Compliance and Monitoring (DOCM) ? each of whom reports to and meets regularly with ACC Director Dr. Robert Vonderheide. The CTSRMC and the ACC Director have full authority to terminate any cancer trial at Penn or CHOP. Both the University of Pennsylvania and the CHOP Internal Review Boards rely on CTSRMC/PPRC for scientific review of cancer clinical protocols and require CTSRMC/PPRC approval prior to final IRB approval. CTSRMC/PPRC efforts do not duplicate functions of IRB, Data Safety Monitoring, or central NCI review bodies. At the time of the last CCSG review, our PRMS was deemed ?Acceptable.? In the current funding period, enhancements to PRMS include further operationalizing our longstanding ?first-stage? protocol review, following the guidance of the new CCSG FOA, as well as decreasing protocol activation times by 50% (such that the average time-to-activation is now 88 business days). The latter was accomplished by developing improved tools for data tracking and reporting, implementing sponsor Master Agreements to minimize budget and contract issues, increasing utilization of CIRB and commercial IRBs, and instituting reciprocity agreements with other peer PRMS committees.
Specific Aims for PRMS are: (1) Support a first-stage review of clinical protocols at the disease- or discipline-level via our specialized CRUs; (2) Provide a second-stage scientific, statistical and feasibility review via CTSRMC/PPRC, which holds sole authority for approval of cancer clinical protocols, and (3) Provide continuing review by CTSRMC/PPRC of open protocols, including assessment of accrual, safety data, and scientific relevance, with authority to close trials for deficient accrual, unacceptable safety or scientific deficiencies.
|Nicastri, Michael C; Rebecca, Vito W; Amaravadi, Ravi K et al. (2018) Dimeric quinacrines as chemical tools to identify PPT1, a new regulator of autophagy in cancer cells. Mol Cell Oncol 5:e1395504|
|Micallef, Ivana N; Stiff, Patrick J; Nademanee, Auayporn P et al. (2018) Plerixafor Plus Granulocyte Colony-Stimulating Factor for Patients with Non-Hodgkin Lymphoma and Multiple Myeloma: Long-Term Follow-Up Report. Biol Blood Marrow Transplant 24:1187-1195|
|Medvec, Andrew R; Ecker, Christopher; Kong, Hong et al. (2018) Improved Expansion and In Vivo Function of Patient T Cells by a Serum-free Medium. Mol Ther Methods Clin Dev 8:65-74|
|Acosta, Jonuelle; Wang, Walter; Feldser, David M (2018) Off and back-on again: a tumor suppressor's tale. Oncogene 37:3058-3069|
|Crisalli, Lisa M; Hinkle, Joanne T; Walling, Christopher C et al. (2018) Higher Donor Apheresis Blood Volumes Are Associated with Reduced Relapse Risk and Improved Survival in Reduced-Intensity Allogeneic Transplantations with Unrelated Donors. Biol Blood Marrow Transplant 24:1203-1208|
|Mazaleuskaya, Liudmila L; Salamatipour, Ashkan; Sarantopoulou, Dimitra et al. (2018) Analysis of HETEs in human whole blood by chiral UHPLC-ECAPCI/HRMS. J Lipid Res 59:564-575|
|Facompre, Nicole D; Harmeyer, Kayla M; Sahu, Varun et al. (2018) Targeting JARID1B's demethylase activity blocks a subset of its functions in oral cancer. Oncotarget 9:8985-8998|
|Rosenfeld, Aaron M; Meng, Wenzhao; Chen, Dora Y et al. (2018) Computational Evaluation of B-Cell Clone Sizes in Bulk Populations. Front Immunol 9:1472|
|Shroff, Rachna T; Hendifar, Andrew; McWilliams, Robert R et al. (2018) Rucaparib Monotherapy in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation. JCO Precis Oncol 2018:|
|Fraietta, Joseph A; Lacey, Simon F; Orlando, Elena J et al. (2018) Determinants of response and resistance to CD19 chimeric antigen receptor (CAR) T cell therapy of chronic lymphocytic leukemia. Nat Med 24:563-571|
Showing the most recent 10 out of 1047 publications