AACI Clinical Research Initiative: Improving the Cancer Centers’

Clinical Trials System

Janie Hofacker, RN, MSDirector of Programs

Association of American Cancer Institutes

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Increased complexity of clinical trials

Administrative and operational barriers

Increasing regulatory constraints

Staff retention and training

Lagging patient accrual

Current economy—declining NIH funding

Matching trial revenue with trial care & staff effort

Today’s Clinical Research Challenges

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2006

•CCAF meeting, presenters, Michael Benedict, Bob Powell and Vicki Sallée held a session on clinical research.

•Outcome of the session was positive and CCAF attempted to move forward with initiating a clinical research initiative.

2008

•AACI further assessed the need for a forum of cancer center medical directors and clinical trial office administrators to share best clinical research practices.

2009

•AACI CRI Steering Committee of Clinical Trial Office leaders forms and confirms the need to continue the development of AACI CRI.

•AACI CRI held its first onsite meeting in Chicago attended by more than 75 clinical trial leaders who provided positive feedback for CRI to continue & encouraged the formation of 3 SIGs to address clinical trial barriers over the following year.

History of AACI CRI and CCAF

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To establish an oncology research network where

cancer center clinical research leaders examine and

share best practices to promote the efficient

operation of cancer center clinical research offices.

AACI CRI Mission

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Facilitates peer-to-peer interactions

Examines and shares best practices

Aligns with AACI’s strategic goals to foster

interactions

AACI Clinical Research Initiative

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AACI CRI Steering Committee Members

James P. Thomas, MD, PhD – ChairMedical College of Wisconsin Cancer Center

David Dilts, PhD, MBA,Knight Cancer Institute Oregon Health and Science University

Rhoda Arzoomanian, RN, BSN, MSMUniversity of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Robert DuWors, MPAJonsson Comprehensive Cancer Center, UCLA

Jordan Berlin, MDVanderbilt-Ingram Cancer Center

Miriam Bischoff, MS, MBAStanford University Comprehensive Cancer Center

Douglas Stahl, PhD, MBACity of Hope National Medical Center and Beckman Research Institute

Joyce Yasko, PhDRoswell Park Cancer Institute

Diana Naser, RN, MSN, MS, CCRPVanderbilt-Ingram Cancer Center

Janie Hofacker, RN, MSAssociation of American Cancer Institutes

Barbara Duffy Stewart, MPH Association of American Cancer Institutes

Sara McNees, PhDThe Dan L. Duncan Cancer Center at Baylor College of Medicine

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Trial MetricsNCI CTRP

AACI CRI

Subsites & Networks

Quality Assurance

Regulatory & Pre-

activation

Industry & Academic & Government

Relationships

Business Administration and Integration

Kerry BridgesSarah Marcotte

Diana NaserJoyce Yasko

Joy OstroffSherrie

Reynolds

Vickie SalleeRenee Webb

David Dilts Doug Stahl

Sarah McNeesLee Doherty

Rhoda ArzoomanianRob DuWors

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Created the CRI Listserv CRIListServ@aaci-cancer.org

◦ Currently over 200 members are subscribed to the listserv.◦ The Listserv allows our members to ask questions & obtain information from

each other & to provide information on new cancer research challenges.◦ Allows AACI to communicate important clinical research related updates.

Developed a quarterly newsletter which communicates SIG progress as well as regulatory, industry, public policy news, and national and regulatory changes impacting oncology clinical research (e.g., NCI, FDA, CMS. etc.)

Created a CRI website providing CRI related SOPs, SIGs updates, meeting schedules and provides CRI templates and documents that are available for AACI CRI members. http://aaci-cancer.org/cri.asp

Communication & Visibility

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NCI CTRP

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February 2009, at a CCAF meeting, the NCI CTRP implementation was identified as being

problematic for cancer centers.

July 2009, at the 1st annual AACI CRI meeting, many participants voiced concerns re: CTRP and its

impact on cancer center resources.

August 2009, AACI assumed responsibility for facilitating a solution to this problem identified by

both CCAF & CRI and initiates a NCI CTRP SIG (R. Arzoomanian, M. Suppman, A. DellaCroce, and R.

DuWors).

Fall 2010, minimal progress is made with to get NCI to listen to the concerns expressed by the SIG.

January 2010, AACI obtains support of several CC directors to meet with Dr. Doroshow to

communicate their concerns.

Dr. Doroshow agrees with AACI that an oversight committee is necessary to review the CTRP

implementation and its impact on the cancer centers.

Background on the NCI CTRP

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NCI CTRP Strategic Subcommittee Members

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Kevin Cullen, M.D., Co-Chair, Director, University of Maryland, Greenebaum Cancer Center

Sheila Prindiville, MD, MPH, Co-Chair, Director, Coordinating Center for Clinical Trials, National Cancer Institute

Rhoda Arzoomanian, MSM, Assistant for Clinical Research, University of Wisconsin Carbone Comprehensive Cancer Center

Jan Buckner, MD, Professor of Oncology, Mayo Clinic College of Medicine

Alyssa K. DellaCroce, MPH, CCRP, Assistant Director, Quality Assurance Office for Clinical Trials, Dana-Farber Cancer Institute

Rob DuWors, MPA, Deputy Director, Administration and Finance, Jonsson Comprehensive Cancer Center, UCLA

Collette Houston, Director, Clinical Research Operations, Office of Clinical Research, Memorial Sloan-Kettering Cancer Center

Nicholas J. Petrelli, M.D., Medical Director, Helen F Graham Cancer Center at Christiana Care

Daniel M. Sullivan, M.D., Executive Vice President/Associate Center Director for Clinical Investigations, Moffitt Cancer Center

James Thomas, M.D., PhD, Associate Director, Clinical Investigation, Medical College of Wisconsin Cancer Center

AACI Liasion:Janie Hofacker, RN, MSN, Director of Programs, Association of American Cancer Institutes

January 2010

NCI Agrees oversight

committee needed

July 2010NCI CTRP Strategic

Subcommittee forms &

establishes goals

April 2011 Executive summary report is

being prepared to be presented to NCI caBIG CTMS Steering

Committee

NCI CTRP Strategic Subcommittee

Co chaired by Dr. Kevin Cullen and Dr. Sheila Prindiville‐

Met via 6 teleconference calls

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CRI SIG LeadersRhoda Arzoomanian & Robb DuWors &

1. Assess estimated work burden of four phases of reporting for individual

centers

2. Assess current and future state of commercial software to facilitate

submission

3. Make policy recommendations to clarify scope of trials, range of

individual patient demographic and outcome data amendments, etc.

4. Hope to report by Dec 10.

NCI CTRP Strategic Subcommittee Work pending as

of As of October 2010

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Specific accrual information and subject demographics to be provided by trial type.

Clarity regarding trial amendments and updates to be reported. Cancer Center workload efforts from several cancer centers has

been provided and reviewed to assess continued NCI support. Committee is recommending trial registration information be

consistent with Summary 3 and Summary 4 reporting to assure that CC sites are given credit for accruals for multisite trials.

Feedback from the commercial CTMS Vendors, Forte’s and Velos’, ability to report clinical trial data has been obtained.

Clarification of the type of trials, interventional, required to be registered to NCI CTRP.

NCI CTRP Strategic Subcommittee Work Completed by April 2011

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Cancer Centers without commercial vendors or automated systems proposed timeline to report to CTRP is being discussed.

Non-interventional trial registration and subject toxicity and response reporting will be considered at later time.

Formal Executive Summary is being drafted and committee’s recommendations will be presented to the caBIG CTMS Steering Committee shortly.

Communication will be provided regarding the final reporting requirements to NCI CTRP Website, CCAF and AACI CRI.

Final report being prepared.

NCI CTRP Strategic Subcommittee Work Completed by April 2011 (continued)

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Timeline for CTRP Registration and Accrual

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AACI CRI Surveys

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Background

◦ US academic institutions have a cancer center and/or have an active CTSA.

Both the cancer center and the CTSA are actively involved in implementing

software systems including electronic health records, clinical trials

management systems, and financial billing systems.

◦ There is little information available about which systems are currently being

used, or whether cancer centers, institutions with CTSAs and institutions as a

whole are working together on these efforts.

Rationale for the Survey

◦ The current survey was intended to provide data concerning current practices

related to these issues, with the long range goal of developing

more effective, integrated systems for the entire community.

Software Survey

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AACI Members

NCI Designated Cancer Centers

Institutions with CTSA

Institutions with an onsite cancer program

AACI Members whose parent institution has a CSTA

Number of Survey Respondents

94 62 55 54 53 *58

Software Survey Summary

* 3 AACI Members share 1 institution with a CTSA & 14 AACI member cancer centers responded who do not have a CTSA at their parent institution.

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Question #4b: Name of Outpatient EMR Application

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N = 58 Cancer Centers

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N = 58 Cancer Centers

Question #5a: What is the Application Used for Cancer Research

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11 types of CTMA applications

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Question # 5c: What is the Application Used in CTSA

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10 types of CTMA applications

No Response Yes No

1

15

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Question #7: Does the Financial Billing Office Application Interface with the CTMA to Assure Clinical Research Billing Compliance?

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N = 58 Cancer Centers

02

25

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Question #8: Describe the Efficiency of the Process

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N = 58 Cancer Centers

There is heterogeneity of systems in use for clinical and research care.

There is minimal integration of the systems to consolidate work efforts.

There are no common systems across institutions and work is done independent of each other.

Summary of the Results

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Are there opportunities for institutions to collaborate in developing multi-institutional common systems such as an EPIC disease registry application?

Ask institutions what they could accomplish by working together developing common research management systems.

Next Steps

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Survey competed in January 2011 Survey purpose - to identify barriers impacting trial activation

Regulatory and Pre-Activation SIG

Yes; 11; 48%

No; 12; 52%

Utilization of NCI CIRB

N = 23 Cancer Centers

Days

60

120

NCI CIRB Local IRB

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Reasons for not using NCI IRB:◦ Bad reputation◦Quality of the review◦ Local IRB won’t permit review by NCI CIRB

The SIG is working to develop standardized IIT Protocol templates to facilitate reviews through committees.

Reviewing process steps and determining ways to consolidate reviews to complete in parallel rather than sequentially.

Regulatory & Pre-Activations (cont)

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A comprehensive clinical trial budget template exists to facilitate budget development and maximize cost recovery of clinical trial care and staff effort.

Developed a Trial Sponsor Monitoring Visit SOP to help cancer centers gain control of their clinical research office while conducing industry sponsored site visits.

Developing standardized job descriptions for budget and contract analyst positions.

Business Administration and Integration SIG

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Recently completed a survey to assess cancer center challenges in opening trials in cancer center networks and use of subsites.

Survey reveals best practices for monitoring of trial data, site selection, dispensing investigational agents to sites, numbers of dedicated staff working on network trials, etc.

SIG is looking to develop training guidelines and SOPs to be used across cancer centers.

Networks and Subsites SIG

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Partnership with the CEO Roundtable on Cancer’s Life Sciences Consortium to facilitate relationships between academic cancer centers and pharmaceutical and biotech companies

Developing a guidance document demonstrating investigator and clinical research staff research education to eliminate duplicate training requests from industry sponsors.

Industry, Academic & Government Relationships

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Working with ASCO to enhance the dialogue between providers and payers regarding coverage clinical research care and eliminating administrative burden and “hassle factor” often making it challenging for timely enrollment of subjects on to a clinical trial. ◦ Solution-oriented projects developed through information sharing

among PPI members can positively impact both of these issues. ◦ Future meeting planned in Fall 2011.

Recently worked with ASCO to provide comments to CMS requests regarding the direct coverage of Medicare Advantage plans rather than having patients submit claims to MA payers.

Providers and Payers Initiatives

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Intercontinental in Chicago O'Hare New to the Meeting Program: Cancer Center Abstract

presentations Presenters: Linda Weiss and James Abrams to discuss the NCI

Support of clinical research at the cancer centers. Industry Perspective from the CEO Roundtable on Cancer Life

Sciences Consortium. FDA presentation to address FDA’s plans to speed up drug

approval plans. CRI SIG updates & meeting break out sessions

3rd Annual AACI CRI MeetingJuly 14-16, 2011

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