1. Oncology Clinical Trials
Sylvia O’Neill, MD
Executive Director
Clinical Research Organization
Teresa Cardoso, MS,BSN,RN
Clinical Trial Nurse Educator

2. Sidney Kimmel Cancer Center (SKCC)
US News and World Report ranked No.20 in the nation for
Increased ranking from No.29

3. Sidney Kimmel Cancer Center (SKCC)
Founded in 1991
1995 became a NCI -Designated Center
One of 69 NCI-designated institutions in United States

4. 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

5. 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 Center’s research portfolio, leadership, and infrastructure
SKCC CCSG next anticipated renewal 2021
NCI Parent Committee
Renewal and Funding
Site Report
NCI Advisory Board

6. 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

7. Clinical Protocol and Data Management (CPDM)

8. Karen Knudsen, PhD SKCC Director
William Kevin Kelly, DO
Associate Director of Clinical Research
Sylvia O’Neill, MD Executive Director
Clinical Research Organization
Early Drug Development Office
Sr. Director Barbara Osborne,RN,MPH,MBA
Clinical Trials Office
Sr. Director, Meghan Wakefield, RN,CCRP
Regional Network Office
Sr. Director, Joshua Schoppe, MPH,CCRP
Protocol Support Unit
Director, Sarah deVries, MSEd, CCRP
Quality Assurance and Process Improvement Unit
Director, Christine Jerome, BS, CCRP

9. Clinical Nurse Educator PRMS and DSMC Coordinator
K. Knudsen, PhD
SKCC Director
M. Huesser, MBA
AD Admin & Ops
W.K. Kelly, DO
AD Clinical Research
Adam Berger,MD
PRC Chair
S. O’Neill, MD
CRO Exec. Director
J. Hoffman-Censits, MD DSMC Chair
Clinical Nurse Educator
T. Cardoso*
OnCore (JeffTrials)
IT Administrator
N. Van Kuren
Clinical Trials Office (CTO) M. Wakefield
Senior Director
Early Drug Development Office (EDDO)
B. Osborne
Senior Director
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

10. Multidisciplinary Disease Group (MDGs)
Solid tumor
Breast GI GU
Aerodigestive
Heme
Melanoma
Phase I
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

11. 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

12. 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

13. Interventional vs. Non-Interventional Studies
*Participants are assigned to receive one or more interventions (or no intervention)
*Evaluate effects of interventions on biomedical or health-related outcomes
Examples:
Diagnostic studies
Screening studies
Treatment studies
Non-Interventional
*Prospective or retrospective studies collecting data and not interfering with the choice of treatment, sample collection, procedures and the treatment itself.
Observational studies
Epidemiology studies

14. DSM Plan AE/SAE Reporting Guidelines*
Grade 1
Grade 2
Grade 3
Grades 4 and 5
Unexpected and Expected
Unexpected
Expected
With Hospitalization
Without Hospitalization
Unrelated
Unlikely
Reviewed at Quarterly DSMC Meeting and IRB Annual Review
5 Working Days
Phase 1 -
48 Hours
(Death: 24 Hours)
Phase 2 -
Possible
Probable
Definite
48 Hour
5 Working Days
48 Hours (Death: 24 Hours)
Phase 1 and Phase 2 -
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

15. Adverse Event Grading in Oncology Clinical Trials

16. Protocol Review and Monitoring System (PRMS)

17. Protocol Review Committee (PRC)
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
ADAM BERGER, MD, FACS
Protocol Review Committee Chair

18. 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

19. New Protocol Submission Process
MDG
Facilitation Committee
Amendments and CRs
New trial
PRC and IRB
Simultaneous
PRC
90 Days
IRB
Activation

20. 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.

21. 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

22. or
? QUESTIONS?