ROAD MAP: Getting a Cancer Study Done at Jefferson Sylvia O’Neill, MD Associate Director of Regulatory Affairs and Quality Assurance Clinical Trials Office

NCI Guidelines AKA: the CORE Grant As an NCI Designated Cancer Center we are mandated to follow the current NCI guidelines. All cancer trials enrollment need to be registered All status changes are done through Alex Lebrun

Associate Director of Clinical Research Executive Director Clinical Research Office Early Drug Development Unit Senior Director Phase I Unit EDCTN/Sara Cannon Molecular Targeted Therapies Clinical Trials Office Senior Director GI Malignancies Aero-Digestive Malignancies Hematologic Malignancies Women’s Cancer GU Malignancies Melanoma and Cutaneous Malignancies Solid Tumors Regional Network\ Cooperative Trials Senior Director Cooperative Groups Abington SKCC Network Affiliates LIMR Other Quality Assurance and Training Clinical Research Support Unit * Physician Leader Figure 1 *Physician Leader *Physician Leader Protocol Review Committee Data Monitoring Committee Executive Committee SKCC Director Clinical Research Oversight Committee Sidney Kimmel Cancer Network Senior Advisor of Oncology Clinical\Research *Report to the Associate Director of Clinical Research Leaders Comm. Deputy Director

SKCC Molecular Targeted Network Site NCI Foundation Medicine TJU + Site Universal Consent Tumor Profiling Molecular Tumor Data Repository Screening Data for Targeted Therapy Notify Site of Clinical Trial Match Figure 2

The submission process MDG PRC IRB PRC and IRB Simultaneous Amendments New trial

Multi-disciplinary Groups GI Aero-Digestive Hematologic Women’s Cancer GU Melanoma and Cutaneous Malignacies Solid Tumors

Protocol Review Committee (fka: CCRRC) comprises investigators broadly representing basic and clinical sciences that: Reviews scientific integrity of cancer clinical trials Meetings occur the second and fourth Monday of the month Deadlines are two weeks prior to the meeting Reviewers are not confidential and there is open communication Cancer trials are not reviewed by IRB without written PRC approval IRB copied on correspondence from PRC to PIs regarding trial closure for compliance or accrual Assures protocol compliance by monitoring accrual

Protocol Review Committee Approval Format: Approved Approved with administrative changes Changes must be made but do not need to come back to PRC Approval with the following recommendations --- optional The PRC will sign off on protocols with no further review and the IRB will be made aware of the recommendations. Changes are not required and do not need to come back to PRC Conditional approval with mandatory stipulation changes The PRC final approval letter will not be sent to the PI until the issues raised here are completed satisfactorily Changes come back to the Administrative Chair for verification of change but do not go back to the full board for approval Disapproved- revisions needed Disapproved

PRC Amendment review When must an amendment get PRC approval? The amendment changes at least one of the following: a. Inclusion/exclusion criteria b. Objectives c. Statistics d. Subject population How do amendments get submitted to PRC? Send an to: and attach the following documents: 1. MCSF with tracked changes 2. Summary of changes 3. Tracked

Closure Policy Per NCI Guidelines we must close trials that are not or have low accruals. Zero accrual at 6 months after activation Have less than 15% after 6 months of activation Have less than 30 % after one year of activation We are allowed to suspend the clock on a trial, please notify us at

Data Safety Monitoring Committee Policy established in collaboration with the NCI in 2011 Meets quarterly Currently oversees 42 IIT clinical trials The DSMC coordinator assigns a Medical Monitor – recommends continuation, suspension, or termination May call for an adhoc meeting to discuss action plans Assign a category of risk to every IIT

In a nutshell….. Call our Clinical Trials Office (fka CRMO) the PRC at :