Transcript Slide 1

Janie Hofacker, RN, MS
Director of Programs
Association of American Cancer Institutes
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Increased complexity of clinical trials
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Administrative and operational barriers
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Increasing regulatory constraints
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Staff retention and training
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Lagging patient accrual
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Current economy—declining NIH funding
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Matching trial revenue with trial care & staff effort
2006
2008
2009
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• 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.
• AACI further assessed the need for a forum of cancer center medical directors and clinical trial
office administrators to share best clinical research practices.
• 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.
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.
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Facilitates peer-to-peer interactions
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Examines and shares best practices
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Aligns with AACI’s strategic goals to foster
interactions
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James P. Thomas, MD, PhD – Chair
Medical College of Wisconsin Cancer Center
David Dilts, PhD, MBA,
Knight Cancer Institute Oregon Health and
Science University
Rhoda Arzoomanian, RN, BSN, MSM
University of Wisconsin Paul P. Carbone
Comprehensive Cancer Center
Robert DuWors, MPA
Jonsson Comprehensive Cancer Center, UCLA
Jordan Berlin, MD
Vanderbilt-Ingram Cancer Center
Miriam Bischoff, MS, MBA
Stanford University Comprehensive Cancer
Center
Douglas Stahl, PhD, MBA
City of Hope National Medical Center and
Beckman Research Institute
Joyce Yasko, PhD
Roswell Park Cancer Institute
Diana Naser, RN, MSN, MS, CCRP
Vanderbilt-Ingram Cancer Center
Janie Hofacker, RN, MS
Association of American Cancer Institutes
Barbara Duffy Stewart, MPH
Association of American Cancer Institutes
Sara McNees, PhD
The Dan L. Duncan Cancer Center at Baylor
College of Medicine
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Diana Naser
Joyce Yasko
Kerry Bridges
Sarah Marcotte
Industry &
Academic &
Government
Relationships
Business
Administration
and Integration
Joy Ostroff
Sherrie
Reynolds
Subsites &
Networks
Vickie Sallee
Renee Webb
Sarah McNees
Lee Doherty
AACI CRI
Quality
Assurance
Rhoda
Arzoomanian
Rob DuWors
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NCI CTRP
Regulatory &
Preactivation
Trial Metrics
David Dilts
Doug Stahl
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Created the CRI Listserv [email protected]
◦ 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.
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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.)
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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
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February 2009, at a CCAF meeting, the NCI CTRP implementation was identified as being
problematic for cancer centers.
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July 2009, at the 1st annual AACI CRI meeting, many participants voiced concerns re: CTRP and its
impact on cancer center resources.
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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).
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Fall 2010, minimal progress is made with to get NCI to listen to the concerns expressed by the SIG.
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January 2010, AACI obtains support of several CC directors to meet with Dr. Doroshow to
communicate their concerns.
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Dr. Doroshow agrees with AACI that an oversight committee is necessary to review the CTRP
implementation and its impact on the cancer centers.
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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
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Co‐chaired by Dr. Kevin Cullen and Dr. Sheila Prindiville
January 2010
NCI Agrees
oversight
committee
needed
July 2010
NCI CTRP
Strategic
Subcommittee
forms &
establishes goals
CRI SIG Leaders
Rhoda Arzoomanian
& Robb DuWors &
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April 2011
Executive summary report is
being prepared to be presented
to NCI caBIG CTMS Steering
Committee
Met via 6 teleconference calls
NCI CTRP Strategic
Subcommittee Work pending as
of As of October 2010
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Assess estimated work burden of four phases of reporting for individual
centers
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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.
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Hope to report by Dec 10.
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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.
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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.
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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.
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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.
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AACI
Members
NCI
Designated
Cancer
Centers
Institutions Institutions AACI
with CTSA with an
Members
onsite
whose
cancer
parent
program
institution
has a CSTA
Number of
Survey
Respondents
94
62
55
*58
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53
* 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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1
Logician
Aria
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2
Commerical
MOSAIQ
Allscripts
5
Eclypsis Sunrise…
EPIC
Homegrown
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No Response or…
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Cerner
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3
Centricity (GE)
1
None
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3
Oacis
Longitudinal medical…
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Quest
14 types of EMR applications
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N = 58 Cancer Centers
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22
1
1
CREDIT
DDOTS
1
1
1
TES (Trial Enrollment
System)
InfoEd CTMS
Oncore (Forte
Research Systems)
N = 58 Cancer Centers
Velos e-Research
Homegrown
3
None
1
Surveyor
1
2
NOTIS
eResearch
Technologies (eRT)…
No Response or
Unknown
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CaBIG Suite
11 types of CTMA applications
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14
9
23
1
1
eNOTIS
InfoEd CTMS
Open Clinica
Oracle Clinical,
SiteMinder and…
Study Manager
CaBIG Suite
10 types of CTMA applications
No Response or
Unknown
None
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Velos e-Research
1
3
Oncore (Forte
Research Systems)
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3
N/A
1
3
Homegrown
1
2
Click Comerace
N = 58 Cancer Centers
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12
42
N = 58 Cancer Centers
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1
No Response
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Yes
No
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N = 58 Cancer Centers
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0
Full automation
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2
No Response or
Unknown
No automation,
Partial automated
requires complete
process, requires
manual review some manual review
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There is heterogeneity of systems in use for clinical and
research care.
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There is minimal integration of the systems to
consolidate work efforts.
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There are no common systems across institutions and
work is done independent of each other.
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Are there opportunities for institutions to collaborate
in developing multi-institutional common systems such
as an EPIC disease registry application?
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Ask institutions what they could accomplish by working
together developing common research management
systems.
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Survey competed in January 2011
Survey purpose - to identify barriers impacting trial activation
Utilization of NCI CIRB
No,
12,
52%
Yes,
11,
48%
NCI CIRB
120
60
Days
N = 23 Cancer Centers
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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
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The SIG is working to develop standardized IIT Protocol
templates to facilitate reviews through committees.
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Reviewing process steps and determining ways to
consolidate reviews to complete in parallel rather than
sequentially.
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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.
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Developed a Trial Sponsor Monitoring Visit SOP to help
cancer centers gain control of their clinical research
office while conducing industry sponsored site visits.
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Developing standardized job descriptions for budget
and contract analyst positions.
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Recently completed a survey to assess cancer center
challenges in opening trials in cancer center networks
and use of subsites.
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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.
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SIG is looking to develop training guidelines and SOPs to
be used across cancer centers.
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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
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Developing a guidance document demonstrating
investigator and clinical research staff research
education to eliminate duplicate training requests from
industry sponsors.
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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.
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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.
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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