Robert H. Lurie Comprehensive Cancer Center of ... H. Lurie Cancer... · Robert H. Lurie Comprehensive Cancer Center of Northwestern ... ROSWELL PARK CANCER INSTITUTE CORP $ ... •

Robert H. Lurie Comprehensive Cancer Center of Northwestern University-Clinical Trials OfficeStudy Activation Cancer Relevant Trials

Presented to: IRB Brown Bag SessionPresented on: August 17, 2016Presented by: Cary Passaglia, MS/Clinical Trials Office Administrative Director

1975 Northwestern Cancer Center

1993 NCI Cancer Center Support grant

1993 Ann and Robert Lurie endowment -The Robert H. Lurie Cancer Center of Northwestern University

1997 NCI Comprehensive Designation

2002 CCSG Successful Renewal

2005 NCI Center for Cancer Nanotechnology Excellence Grant


2009 NCI Physical Sciences Oncology Center Grant


Lurie Cancer Center History and Overview

NCI Comprehensive Cancer Centers - Year 19Institution Funding

1 UT MD ANDERSON CANCER CTR $97,812,365 2 FRED HUTCHINSON CAN RES CTR $87,302,436 3 UNIVERSITY OF CALIFORNIA, SAN FRANCISCO $73,455,238 4 DANA-FARBER CANCER INST $73,411,204 5 JOHNS HOPKINS UNIVERSITY $70,534,888 6 SLOAN-KETTERING INST CAN RES $70,485,779 7 UNIVERSITY OF MICHIGAN $70,134,291 8 UNIVERSITY OF PENNSYLVANIA $62,898,781 9 VANDERBILT UNIVERSITY MED CTR $60,303,751

10 MAYO CLINIC ROCHESTER $56,780,022 11 UNIV OF NORTH CAROLINA CHAPEL HILL $56,405,795 12 UNIVERSITY OF PITTSBURGH AT PITTSBURGH $50,509,989 13 UNIVERSITY OF CALIFORNIA, LOS ANGELES $46,420,980 14 THE OHIO STATE UNIVERSITY $45,528,881 15 UNIVERSITY OF SOUTHERN CALIFORNIA $42,077,508 16 WASHINGTON UNIVERSITY $41,847,542 17 UNIVERSITY OF CALIFORNIA, SAN DIEGO $35,728,973 18 UNIVERSITY OF MINNESOTA $34,496,975 19 DUKE UNIVERSITY $33,626,775 20 COLUMBIA UNIVERSITY HEALTH SCIENCES $32,963,649 21 NORTHWESTERN UNIVERSITY $30,629,210 22 YALE UNIVERSITY $30,211,004 23 ROSWELL PARK CANCER INSTITUTE CORP $29,788,652 24 H. LEE MOFFITT CANCER CTR & RES INST $29,191,524 25 UNIVERSITY OF WISCONSIN-MADISON $28,262,804 26 CASE WESTERN RESERVE UNIVERSITY $26,271,399 27 UNIVERSITY OF ALABAMA AT BIRMINGHAM $25,209,476 28 CITY OF HOPE/BECKMAN RESEARCH INSTITUTE $24,312,139 29 UNIVERSITY OF CHICAGO $23,812,767 30 UNIVERSITY OF COLORADO DENVER $21,424,224 31 ST. JUDE CHILDREN'S RESEARCH HOSPITAL $21,233,626

Institution Funding 1 Dana-Farber/Harvard Cancer Center $110,797,1262 Fred Hutchinson Cancer Research Center $102,042,6413 Johns Hopkins University $93,365,2414 MD Anderson Cancer Center $93,166,5195 University of California, San Francisco $92,708,6686 Mayo Clinic Cancer Center $82,191,0517 Memorial Sloan-Kettering Cancer Center $70,485,7798 University of Pennsylvania $69,655,4229 Vanderbilt University $67,322,589

10 University of North Carolina $66,345,06111 University of Michigan $55,959,14312 University of Pittsburgh $54,809,69913 University of California, Los Angeles $52,531,50314 The Ohio State University $51,067,59215 Washington University (St. Louis) $41,796,30016 University of Southern California $40,381,98617 Northwestern University $38,210,27518 University of California, San Diego $36,994,25219 University of Minnesota $36,895,64420 Duke University $36,519,19621 Columbia University $35,592,74022 University of Alabama at Birmingham $32,489,06423 University of Wisconsin $28,634,98124 Yale University $28,570,62825 H. Lee Moffitt Cancer Center & Research Institute $27,076,46026 University of Colorado $26,473,58527 University of Chicago $26,133,03828 City of Hope $26,052,93729 Case Western Reserve University $23,775,05430 St. Jude Children's Research Hospital $23,089,87331 Roswell Park Cancer Institute $21,468,771

NCI Comprehensive Cancer Centers - Year 20

Institution Funding1 University of California, San Francisco $67,836,2662 University of Michigan $66,137,2593 Vanderbilt University Medical Center $59,425,4034 John Hopkins University $59,065,2465 University of Pennsylvania $53,954,2376 University of California, Los Angeles $43,034,9507 Washington University $38,804,6008 University of Southern California $38,365,7659 University of Pittsburgh at Pittsburgh $37,878,672

10 The Ohio State University $37,433,47411 University of North Carolina, Chapel Hill $36,374,71212 University of California, San Diego $32,860,94513 Duke University $31,743,03914 Columbia University Health Sciences $28,853,78715 Northwestern University $27,924,35416 University of Minnesota $25,698,15017 Yale University $25,093,60018 University of Wisconsin-Madison $24,833,74419 Case Western reserve University $24,565,33720 University of Chicago $23,303,25821 University of Alabama at Birmingham $22,318,21422 University of Colorado, Denver $19,671,10723 Georgetown University $17,535,49124 University of California, Davis $15,159,84025 University of Arizona $14,432,40126 Dartmouth College $14,395,42427 Wake Forest University Health Sciences $13,092,61528 Wayne State University $12,863,67629 University of Iowa $11,783,79330 University of California, Irvine $4,822,64831 RBHS-New Jersey Medical School $2,080,569

NCI Cancer Center Medical Schools - Year 19

Institution Funding 1 Johns Hopkins University $93,365,241 2 University of California, San Francisco $92,708,668 3 University of Pennsylvania $69,655,422 4 Vanderbilt University $67,322,589 5 University of North Carolina $66,345,061 6 University of Michigan $55,959,143 7 University of Pittsburgh $54,809,699 8 University of California, Los Angeles $52,531,503 9 The Ohio State University $51,067,592

10 Washington University (St. Louis) $41,796,300 11 University of Southern California $40,381,986 12 Northwestern University $38,210,275 13 University of California, San Diego $36,994,252 14 University of Minnesota $36,895,644 15 Duke University $36,519,196 16 Columbia University $35,592,740 17 University of Alabama at Birmingham $32,489,064 18 University of Wisconsin $28,634,981 19 Yale University $28,570,628 20 University of Colorado $26,473,585 21 University of Chicago $26,133,038 22 Case Western Reserve University $23,775,054 23 Georgetown University $20,781,977 24 University of California, Davis $19,501,930 25 Dartmouth College $18,910,351 26 University of Arizona $16,852,448 27 The University of Iowa $15,751,386 28 Wayne State University $13,770,026 29 Wake Forest University $11,925,523 30 RBHS-Cancer Institute of New Jersey $11,078,339 31 University of California, Irvine $9,329,867

NCI Cancer Center Medical Schools - Year 20

DirectorLeonidas C. Platanias, MD, PhD

Deputy DirectorFrancis Giles, MD

Associate DirectorResearch Technology Milan Mrksich, PhD

Cancer Informatics Core Facility Keck Biophysics Facility

High Throughput Analysis Lab

Flow Cytometry Facility

Cell Imaging Facility

Medicinal & Synthetic Chemistry Core

Molecular & Translational Imaging Core

Clinical Research Office

Developmental Therapeutics Core

Pathology Core Facility Structural Biology Facility

Transgenic & Targeted Mutagenesis Lab

Mouse Histology & Phenotyping LabBiostatistics Core Facility

Outcomes Measurement &Survey Core

Center Organizational Structure-CurrentShared Resources

• Cancer Center Administration Organization

Alex ZafirovskiExecutive Director,

Cancer Center

Mark Agulnik Medical Director, Clinical Research Office

Cary Passaglia Administrative Director, Clinical Research Office

Clinical Operations Managers

Study Coordinators

Data Manager

Data Assistants

Regulatory Operations Manager

Regulatory Coordinators

Logistics Operations Manager

Study Start-up/medical writers

TBDAdministrative Director, Financial Administration

Clinical Trials Finance

Recharge

Finance

Budgets

Philanthropic Funding

Renee Webb, Assistant Director, Research

Administration

Grants Administration

Scientific Review

Affiliates

Chemoprevention

Quality Assurance

Research Informatics

• Cancer Center Clinical Trials Office Organization

Medical Director, Clinical Research

Office

Administrative Director, Clinical Research Office

Clinical Operations

Managers: 4

Study Coordinators:35

Data Manager:1

Data Assistants: 17

Regulatory Operations Manager:1

Regulatory Coordinators:10

Logistics Operations Manager:1

Medical Writers: 2

Study Start-Up:2

Lurie Cancer Center Goals - 2016 Increase depth in basic science research

Enhance clinical translation and increase innovative clinical trial activity

Bridge research and clinical care - Redefine the Lurie Cancer Center brand

Optimize clinical cancer care across NM network

Clinical Trials Office

• The Lurie Cancer Center Clinical Trials Office provides a centralized resource to facilitate the development, conduct, quality assurance monitoring, compliance with regulatory agency requirements, and evaluation of clinical research trials at the Lurie Cancer Center. As such, the office coordinates the majority of clinical research conducted in medical oncology, malignant hematology, gynecologic-oncology, neuro-oncology, radiation oncology, surgical oncology, and chemoprevention.

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Cancer Center “Partners”

The Lurie Cancer Center is affiliated with: NMH NMG NU & Feinberg School of Medicine VA RIC LCH

Approximately 290 Full MembersAny cancer-relevant research conducted at any of these facilities must be reported to, and

approved by, the Cancer Center

Clinical Trial Development

Study Coordination

Data Management

Regulatory Support Services

CRO focuses on services related to:

Clinical Trial Development

Medical Writer Services• Assistance writing non-clinical/non-

scientific aspects of protocols.• Facilitate study implementation

meetings to review feasibility and troubleshoot protocol details.

• Preparation of protocol revisions.

Contacts• Please contact Ashlee Drawz to

request assistance: [email protected]

• Medical Writing Team:− Jennifer Kreutzer− Sabeeha Mukit

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Logistics Team

mailto:[email protected]

Study Activation Team

Activation Team Services• Team acts as facilitators of critical

interactions between teams, investigators, and various departments at Northwestern University and Northwestern Medicine.

• Study Start-Up Leads are project managers for overall study activation and assigned to disease teams.

• Collaborate with external partners (industry sponsors, contractors, vendors, and funding sources).

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Protocol Development and Implementation

Regulatory Processing

• As trials receive approval from Disease Teams and Scientific Review Committee, the assigned RC creates the documents to be submitted to the IRB for review.

• The RCs works closely with the Principal Investigator to develop trial documents to be submitted and reviewed by either the NU IRB, NCI’s CIRB or other CIRBs. They also work with the PI to submit Investigational New Drug Applications (IND) to the FDA when applicable.

• The RCs monitor and maintain regulatory documents in compliance with institutional, state and federal guidelines.

• Any trials that require an amendment change are processed by RCs and are submitted to the appropriate IRB for review.

16Footnote, Presentation or Section Title

Clinical Operations

• The Clinical Research Operations Managers provide an essential layer of oversight and training for an increasingly large and complex clinical trials operation.

• Participating in the clinical trial portfolio management in conjunction with the Faculty Disease leader to reflect the research goals, patient resource management and CTO resource allocation of the group.

• Supervising and training of CTO coordinating staff to provide for the efficient and compliant conduct of clinical cancer research trials.

• Assisting the CTO Medical Director and CTO Administrative Director in aligning and developing CTO resources to match with RHLCCC goals


Data Management

• The Data Manager oversees the day-to-day operations for all Data Assistants.

• The Clinical Trials Office participates in Cooperative Group, Industry-sponsored and Investigator-initiated trials, for which Data Coordinators of the CTO complete, collect and enter data via databases and online data repositories.

• Data Assistants are responsible for data management for patients enrolled onto clinical trials.

• They abstract data from Electronic Medical Record systems (EMR) and work closely with PIs, investigators and coordinators to ensure accurate and timely data entry.

• The timeliness of the data submissions is reviewed regularly by the CTO Data Manager.

• Data Assistants coordinate visits with monitors of sponsored studies.


Affiliate Operations

• The Affiliate Operations Manager oversees NCTN and Investigator Initiated affiliate network for The Clinical Trials Office.

• Collaborates with Study-Start-up team, contracts, budgets, QA, and outside affiliate site contacts for study activation at affiliate sites.

• Monitors NCTN affiliate site progress as it pertains to accrual and data timeliness.

• Audits NCTN affiliates to ensure compliance with GCP, NCI, and Federal Regulations.

• Oversees start-up of clinical trials at Jesse Brown VA.• Works with NM network affiliate groups for clinical trial activation and

provides oversight.


Quality Assurance Team

• Team Collaborates with Medical Writers, PI, Affiliate Operations Managers, Pharmacy, Pathology Core for Investigator Initiated Trial activation.

• Ongoing safety reviews of all NU IITs requiring moderate and high intensity monitoring; semi-annual safety reviews for those studies determined to require minimal intensity monitoring.

• Reviews of all serious adverse events (SAEs) that occur on NU IITs. • Reviews of all dose-limiting toxicities (DLTs) for Phase I dose-escalation

studies.• Responsible for FDA annual reports for those studies where the NU PI holds

the Investigational New Drug Application (IND) or Investigational Device Exemption (IDE).

• Present all data to Data Monitoring Committee (DMC) and communicate DMC decisions to PI’s.

• Oversee semi-annual audits of all NU Investigator Initiated Trials.


Study Types

• Defined by CTRP/ClinicalTrials.gov as: “Studies in human beings in which

individuals are assigned by an investigator, based on a protocol, to receive specific interventions. Subjects may receive diagnostic, therapeutic, behavioral or other types of interventions. The assignment of the intervention may or may not be random. The individuals are followed and biomedical and/or health outcomes assessed.

Interventional Studies

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Interventional vs. Non-Interventional

Study Types

• Therapeutic (pertains to cancer therapy: Chemo,Radiation, Surgery,ect.)

• Cancer Control (web-based treatment for symptoms of depression)

• Diagnostic• Early Detection• Epidemiologic• Prevention• Screening• Supportive Care

Interventional Studies

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Study Types

• Non-interventional types: Observational Outcomes Ancillary Correlative

• “Other” types not really considered to be research: Single-Patient Exemptions Emergency Use protocols Compassionate Use protocols

SRC assist with determination of study type at time of review

Non-Interventional Studies

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Research Oversight System (ROS)

• Cancer Center requirement through NIH & NCI An independent system, not designated or controlled by

the clinical trials office Comprised of four separate core committees • Disease Teams• Scientific Review Committee (SRC)• Data Monitoring Committee (DMC)• Clinical Trial Audit Committee (CTAC)

• All new cancer-relevant studies must be submitted to the SRC approval prior to IRB submission Some studies may be considered exempt from SRC (ie,

federally funded, healthy subjects research) – but all must be reported to the CRO for confirmation and tracking purposes

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What is it??

Footnote, Presentation or Section Title

Disease Teams: Provide an integrated, multidisciplinary approach to guide in the selection and prioritization of high quality

cancer research studies.

Scientific Review : Evaluates all cancer-relevant research protocols, including the

review of all protocol amendments

Data Monitoring Committee: Responsible for data and safety monitoring,

monitoring of protocol compliance.

Clinical Trial Audit Committee: Responsible for the internal auditing

program

Oversight System

Disease Teams

DISEASE TEAMS

Multiple Histology and NOS

HEM-Leukemia HEM-LPDs

HEM-MDNsHEM-Transplant

TRIST-SkinTRIST-Lung

TRIST-Head and Neck

TRIST-GITRIST-GU

TRIST-Neuro-Oncology

TRIST-Sarcoma

WC-Breast

WC-Gynecological

• Design quality clinical trials that will be activated and completed quickly

• Monitor the progress of existing trials• Encourage multidisciplinary interaction• Assess trial accrual potential and potential

overlap between competing trials• Assist in the identification and allocation of

resources for conducting clinical trials

Disease TeamsRole

All new cancer-relevant studies must receive SRC approval prior to IRB submission. The exception to this would be if a study has already undergone review by another NCI-approved peer-review body.

Cancer-relevant research may include retrospective reviews, lab-based research, industry, and investigator-initiated trials (IITs)

The SRC will review projects to:

• Evaluate the scientific soundness• Confirm the relevance to Cancer Center goals• Ensure the appropriate usage of a Data and Safety Monitoring Plan

(DSMP)

This review is different from the NU IRB review of projects in that the IRB reviews to ensure the protection and safety of human research subjects.

Scientific Review CommitteeResponsibilities

Could my study be exempt from SRC review?

The NCI provides a list of approved peer-review bodies. This list can be found at http://cancercenters.cancer.gov/documents/fundorg.pdf.

If your study has undergone review and approval by one of these entities, it will likely be considered exempt from SRC review.

Studies that are usually exempt from review include NCI cooperative group-sponsored studies and those funded by a federal grant. Although exempt NCI cooperative group-sponsored studies must be submitted into NOTIS for tracking and prioritization. Exempt studies submitted are administratively reviewed by the Scientific Review Committee Coordinator.

Scientific Review CommitteeFrequently Asked Questions

http://cancercenters.cancer.gov/documents/fundorg.pdf

Is my study considered cancer-relevant? Will SRC approval be required for my study?

Although it would be difficult to list every possible scenario in which a study would be considered cancer-relevant, in general, this means that it involves cancer patients, uses data, tissue, or blood specimens from cancer patients, or will lead to findings that may be significant to cancer patients.

If an Investigator is unsure if a study is considered to be cancer-relevant, please contact the CRO Scientific Review Coordinator, Josalyn Mangrum, to determine if the study must be submitted for SRC review and approval. All cancer relevant studies must be entered into NOTIS.



When is a Letter of Intent (LOI) required and what do I need to include in it?

All Northwestern University (NU) Investigators interested in initiating interventional studies at NU must first complete and submit an LOI. An LOI is not required for any non-interventional study or for investigator-initiated trials initiated by outside institutions. NOTE: LOIs should already have received endorsement by the appropriate Disease Team prior to submission to SRC.

If a New Protocol Submission Form (NPSF) and/or a New Protocol Submission Packet (NPSP) have been submitted to the CRO for a NU interventional IIT before an LOI has been approved for the protocol, the SRCC will contact the PI to request that they first complete an LOI for the study and hold the NPSP until the LOI is approved.

These studies will not be reviewed or approved by the SRC until an LOI has first been approved by the SRC.


When is a Letter of Intent (LOI) required and what do I need to include in it?

A LOI must be submitted on the LOI template http://cancer.northwestern.edu/CRO/library.cfm#NEWShould include details about the following study criteria:• Concept Title• Primary and Secondary Objectives• Study Phase• Design and Rationale• Study Population• Correlative Studies• Treatment Details• Statistics• Feasibility Assessment• Financial Support• IND Involvement• Publication Plan


http://cancer.northwestern.edu/CRO/library.cfm#NEW

How do I submit my study for SRC review and approval?

The Principal Investigator (PI) must submit a new protocol submission packet (NPSP) to the CRO Scientific Review Coordinator, Josalyn Mangrum, via e-mail. This packet must include:

New Protocol Submission Form (NPSF): http://cancer.northwestern.edu/CRO/library.cfm#NEW

Copy of the protocolCopy of the Informed Consent Form (ICF) (if applicable) in editable word formCopy of the Grant (if applicable)Copy of the Investigational Brochure (if applicable)Copy of the Standard of Care vs Research (if applicable)



http://cancer.northwestern.edu/CRO/library.cfm#NEW

New protocol submission form (NPSF) DO NOT SAVE this

form as a template –Please always use the website

PI responsible for completion of NPSF Incorrect

information can cause for delays!

SOC v Research *signed and dated by PI

What is the review process like?

• The committee reviews new protocols twice a month (1st Wednesday and 3rd Thursdays). The schedule is posted on the website.

• The SRC review letter is typically sent to the PI within one week of review. Each project will receive one of the following review outcomes after initial review:

• Approve - No revisions/minor revisions, proceed to IRB• Response and/or Revisions Required Prior to Approval

• To be confirmed administratively• To be confirmed by original reviewers

• Held for Re-Review• Substantial revisions required, will be sent to another meeting

once addressed• Rejected

• Fundamental flaws with study design and/or methods – may not be resubmitted for review.


How long will this take?

The average project is SRC approved in 30 days or less.Submission of a complete protocol, and all required documents (NPSF, Grant, Protocol, ICF) will ensure the most efficient processing.

Please promptly respond to questions and requests from the Scientific Review Coordinator or other reviewers— this will help everything move more quickly!

What specifically will the SRC want to see? What should I include in my protocol to help ensure that it will be approved?

The PI should refer to the templates for protocol development on the CRO website: http://cancer.northwestern.edu/CRO/index.cfmStudies with missing and/or inadequate sections may not be considered complete for submission purposes and will be returned to the PI for further development prior to SRC review.


https://www.cancertrials.northwestern.edu/

http://cancer.northwestern.edu/CRO/index.cfm

Additional resources are available for cancer-relevant research:

• All studies being submitted for SRC review should have clearly stated objectives and a corresponding statistical analysis plan for each objective. Statistical support for cancer- relevant studies is provided by the Lurie Cancer Center’s Biostatistical Core under the direction of Alfred Rademaker, PhD. Please contact Dr. Rademaker to request assistance and ensure appropriate statistical planning prior to LOI submission to the SRC.



When is the next meeting? When am I required to submit a project in order to get it reviewed?

The full meeting schedule through calendar year 2016-2017 with corresponding due dates is available on CRO website. In general, deadlines are approximately 1 week prior to the meeting date to allow time for assignment of reviewers and distribution of review packets.

Every effort will be made to review all submitted studies at the next available meeting; however, when availability on the agenda is limited, review of submitted studies will be scheduled according to the Lurie Cancer Center prioritization rating guidelines.


https://www.cancertrials.northwestern.edu/cpsrms/cpsrms-p-ps

https://www.cancertrials.northwestern.edu/cpsrms/cpsrms-p-ps

CRO Website: http://cancer.northwestern.edu/CRO/index.cfm

Questions?

Thank You

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Robert H. Lurie Comprehensive Cancer Center of ... H. Lurie Cancer... · Robert H. Lurie Comprehensive Cancer Center of Northwestern ... ROSWELL PARK CANCER INSTITUTE CORP $ ... •