Oncology Clinical Trials Sylvia ONeill, MD Executive Director

Oncology Clinical Trials Sylvia ONeill, MD Executive Director

Oncology Clinical Trials Sylvia ONeill, MD Executive Director Clinical Research Organization Teresa Cardoso, MS,BSN,RN Clinical Trial Nurse Educator Clinical Research Organization Sidney Kimmel Cancer Center (SKCC) US News and World Report ranked No.20 in the nation for 2017-2018 Increased ranking from 2016-2017 No.29 Sidney Kimmel Cancer Center (SKCC) Founded in 1991 1995 became a NCI -Designated Center One of 69 NCI-designated institutions in United States What is NCI Designation? NCI-Designated Cancer Centers are recognized for their scientific leadership, in basic, clinical, and/or population science A large NCI grant (also referred to as the P30-Cancer Center Support Grant or CCSG) is submitted and then awarded to institutions who demonstrate the most impact through research

CCSGs currently range from $1.4M-8M/yr Size of the center How long the center has had the CCSG in place Overall impact in the field of oncology as judged by peer scientists NCI-Designation Review Process Grant is renewed every five years One day site visit scheduled October 24, 2017 20 nationally recognized cancer scientists from other NCI-designated centers Evaluating the Centers research portfolio, leadership, and infrastructure Site Repor t NCI Parent Committe e NCI Advisory

Board SKCC CCSG next anticipated renewal 2021 Renewal and Funding What are the NCI Expectations? Clinical Protocol & Data Management (CRO & DSMC) Protocol Review & Monitoring System (PRC) Senior Leadership Administration

Planning and Evaluation Developmental Funds Addressing the Catchment Area Professional Education & Career Development Research Programs Shared Resources Minority & Women in Clinical Research Clinical Protocol and Data Management (CPDM) Karen Knudsen, PhD SKCC Director William William Kevin Kevin Kelly, Kelly, DO DO Associate Associate Director Director of of Clinical Clinical Research

Research Sylvia Sylvia ONeill, ONeill, MD MD Executive Executive Director Director Clinical Clinical Research Research Organization Organization 215-275-3045 215-275-3045 Protocol Protocol Support Support Unit Unit Director, Director, Sarah Sarah deVries, deVries, MSEd, MSEd, CCRP

CCRP 814-404-6443 814-404-6443 Early Early Drug Drug Development Development Office Office Sr. Sr. Director Director Barbara Barbara Osborne,RN,MPH, Osborne,RN,MPH, MBA MBA 267-640267-6406519 6519 Quality Quality Assurance Assurance and

and Process Process Improvement Improvement Unit Unit Director, Director, Christine Christine Jerome, Jerome, BS, BS, CCRP CCRP 215-498-3399 215-498-3399 Clinical Clinical Trials Trials Office Office Sr. Sr. Director, Director, Meghan Meghan Wakefield, Wakefield, RN,CCRP

RN,CCRP 267-315-3562 267-315-3562 Regional Regional Network Network Office Office Sr. Sr. Director, Director, Joshua Joshua Schoppe, Schoppe, MPH,CCRP MPH,CCRP 267-872267-8727414 7414 K. Knudsen, PhD SKCC Director M. Huesser, MBA AD Admin & Ops

Adam Berger,MD PRC Chair W.K. Kelly, DO AD Clinical Research S. ONeill, MD CRO Exec. Director OnCore (JeffTrials) IT Administrator N. Van Kuren Clinical Nurse Educator T. Cardoso* Clinical Trials Office (CTO) M. Wakefield Senior Director Early Drug Development Office (EDDO) B. Osborne Senior Director

J. Hoffman-Censits, MD DSMC Chair Reginal Network Office J. Schoppe Senior Director Protocol Support Unit (PSU) S. deVries Director Quality Assurance & Process Improvement Unit (QIU) C. Jerome Director PRMS and DSMC Coordinator A. Madineni Multidisciplinary Disease Group (MDGs) Brain, CNS, GYN-Cervix, Endometrial, Pelvic, Ovarian, Uterine

Breast Colon, Gastric, Gastro-esophageal, Hepatocellular, Pancreatic, Rectal Bladder, Prostate, Renal Head, Laryngeal, Lips, Lung, Nasal, Oral Cavity, Pharyngeal, Thoracic BMT, Leukemia, Lymphoma, MDS, Myeloma Melanoma, Uveal Melanoma All Solid Tumor Types Data and Safety Monitoring Committee (DSMC) JEAN HOFFMAN-CENSITS, MD Data and Safety Monitoring Chair NCI requirement and subsection of CPDM component Administratively supported by the QA and Process Improvement Unit (QIU) of the CRO Reports to Dr. Kelly, AD Clinical Research

Data and Safety Monitoring Committee (DSMC) Reviews all IIT interventional trials regardless of phases and is part of the DSMP that is approved by the NCI Meets quarterly or ad hoc Mandatory dose escalation/cohort expansion meetings IRB notified at continuing review since delineated in the protocol Assigns medical monitors before a trial is activated Review SAEs in real time Recommends continuation, suspension, or termination IRB notified in real time if deemed major by the DSMC and at CR if minor Interventional vs. Non-Interventional Studies DSM Plan AE/SAE Reporting Guidelines* Grade 1 Unexpected and Expected Grade 2

Grade 3 Grades 4 and 5 Unexpected Unexpected Expected With Hospitalization Expected Without Hospitalization With Hospitalization Without Hospitalization Unexpected and Expected Phase 1 Reviewed at

Reviewed at Reviewed at Quarterly Quarterly Quarterly Unrelated DSMC DSMC DSMC Unlikely Meeting and Meeting and

Meeting and IRB Annual IRB Annual IRB Annual Review Review Review 5 Working Days Reviewed at Reviewed at Quarterly Quarterly DSMC Meeting

5 Working Days DSMC Meeting and IRB Annual and IRB Annual Review Review 48 Hours (Death: 24 Hours) Phase 2 5 Working Days Reviewed at Quarterly Possible Probable Definite

DSMC Meeting and IRB Annual Review Reviewed at Quarterly DSMC Meeting and IRB Annual Review Reviewed at Quarterly DSMC Meeting and IRB Annual Review Phase 1 48 Hour (Death: 24

Hours) 48 Hours Phase 2 5 Working Days Reviewed at 48 Hours Quarterly (Death: 24 DSMC Meeting Hours) and IRB Annual Review Phase 1 and Phase 2 48 Hours (Death: 24 Hours)

NOTE: This table is based on the NCI AE/SAE reporting Guidelines and the TJU IRB Policy and Procedures. Please follow the individual protocol AE/SAE reporting guidelines if more stringent reporting procedures are specified. *From the KCC DMS Plan version 2.10, page 18 Adverse Event Grading in Oncology Clinical Trials Protocol Review and Monitoring System (PRMS) Protocol Review Committee (PRC) ADAM BERGER, MD, FACS Protocol Review Committee Chair Responsibilities Reviews all clinical trials for scientific merit, prioritization, progress, feasibility Not to duplicate IRB efforts Reviews trials at least annually Closes trials : Lack of scientific progress

lack accrual within 6 months Protocol Review Committee (PRC) All new studies, including retrospective chart reviews, must be submitted to PRC and get approved before they can go to IRB Some protocol amendments must be submitted to PRC for approval PRC does not review informed consent PRC meets twice a month New Protocol Submission Process MDG Facilitation Committee Amendmen ts and CRs New trial PRC and IRB Simultaneous IRB

Activation 90 Days PRC Overview of the NCI Central (CIRB) Model MISSION: National efficient review of oncology clinical trials funded by the NCI Helping the NCI accelerate scientific discovery and improve cancer prevention, treatment and care. Protection of the rights and welfare of participants in cancer clinical trials. Ethical and quality standards. NCI CIRB History Previous model of facilitated review was parallel process Current model As of January 1, 2014 CIRB operates as independent model CIRB is IRB of Record Required for NCTN studies

SOP for TJU IRB and CRO OHR-8K or ? QUESTIONS?

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