Transcript Document
Affiliate Networks
Comprehensive Cancer Center Perspective
Michael Benedict, PharmD
Vice President, Research
Moffitt Cancer Center
Today
Brief overview of Moffitt History with
Affiliates
Successes and Challenges
Total Cancer Care Initiative
Partnering with NCCCP sites
External Research Sites : 2010
Cancer Centers of Florida
Mayo Clinic, Jacksonville
Ocala Oncology
Univ. of Florida - Gainesville
Bethesda Memorial Hosp.
Project Type
Broward General Med. Ctr.
North Broward Med. Ctr.
Martin Memorial Hospital
Ponce School of Med.
FIQCC
CCC&R/Watson Clinic
Tallahassee Memorial
Space Coast Med. Assoc.
Southeast Nebraska Cancer Ctr.
MCC Non Intervention
Sarasota Memorial Hospital
MCC Clinical Intervention
Baptist Hospital of Miami
MCC Prevention
Carolinas Medical Center
Cooperative Group
Our Lady of the Lake
St. Vincents of Indiana
Louisiana State Univ.
Univ. of FL - Jacksonville
Medical Univ. of SC
National Cancer Institute
Emory University
Univ. of North Carolina
Vanderbilt University
SEP2C
Greenville Hospital System
Hartford Hospital
Cleveland Clinic
Fox Chase Cancer Center
Billings Cancer Center
Boca Raton Com. Hosp.
Klinik Lowenstein, Germany
Minneapolis VA
Florida GYN Oncology
St. Joseph’s Hospital - Tampa
Jefferson Medical College
Overton Brooks VA
Leesburg Regional Med. Ctr.
Morton Plant Mease
James A. Haley VA
Johns Hopkins Univ.
St. Joe’s Candler, Savannah
Women’s Cancer Assoc.
Duke University
Virginia Commonwealth Univ.
Univ. of Maryland
Univ. of Chicago
Total Cancer Care
Cornell University
Montefiore Medical Ctr.
Univ. of Louisville
The Situation
Only 2-4% of adult cancer patients enrolled in
clinical trials Klabunde CN etal JNCI 2011
85% of cancer patients are treated in their local
community
Lack of practice standards and quality
measurements
Patient centered outcomes research requires
community participation
Access to clinical trials, esp. underserved
populations is a challenge
Molecularly directed medicine requires new
approaches, infrastructure, and connections
Benefits
Expands treatment options for the patient
in the community
Patients can be treated close to home
decreasing costs of travel and time
Collaboration of institutions may increase
referrals for both institutions
Increase market advantage for community
Barriers
Cost - inadequate funding
Lack of interesting trials
Trial characteristics that may be
difficult to implement in community
Extra-biopsy
Advanced Imaging
Increased regulatory burden
IRB availability or funding
Monitoring and oversight
Moffitt History with Affiliates
Program began in 1998
Part of Moffitt State Mandate
Instrumentality of the State
Designate “Partner Hospitals”
Export trials
Educational opportunities, use of
name/logo: Branding
Referrals, marketing advantage
Focus cooperative group trials
Moffitt Clinical Research Network - 2006
Office created to provide oversight
and centralization
Protocol review and preparation
Site approval/credentialing
Liaison between Moffitt & site staff
Regulatory, contracting, budget, payment
Assisted with data entry & monitoring
Training resource
Moffitt Clinical Research Network
Re-invigoration of the program
Identified physician champion
Concerted effort to place Investigator Initiated
Trials (IIT) in the community
Lot of Interest
Limited success
Accrual inconsistent
Funding poor
Complicated, difficult to implement
Emergence of academic affiliations
Project Sunshine
N01 – Southeast Phase II Consortium
Total Cancer Care Consortium – M2Gen
Personalized Approach to a Patient’s Cancer
Journey
Survivorship
–
–
–
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Populations at Risk
Behavioral Research
Psychosocial & Palliative Care
Family Needs
Health Outcomes
–
–
–
–
Relapsed Disease
Intervention
– Recurrence Therapy
– Drug Discovery
– Adaptive Trial Design
– Prevention
– Lifestyle/Nutrition
– Education
Diagnosis
Treatment
– Primary Therapy
• Multimodality
• Target Based
– Post Therapy
• Surveillance
– Clinical Trials Matching
– Genomics/Proteomics
– Imaging Modalities
– Nanotechnology
Prognosis
– Molecular Oncology
– Biomarker Analysis
(http://www.hhs.gov/myhealthcare/news/phc_2008_report.pdf; pg 243)
Risk Factors
Genetics
Early Detection
Health Disparities
The Purpose
Identify the needs of individual patients;
Identify markers that would predict needs and
risks so that interventions could become
preemptive;
Identify molecular signatures for patients who are
not likely to respond to standard of care;
Utilize clinical characteristics and molecular
profiling techniques to match the right patient to
the right treatment at the right time the first
time;
Raise the standard of care for all patients by
integrating new technologies in an evidenced
based approach to maximize benefits and reduce
costs.
The Approach for Cancer
Total Cancer Care Protocol
Can we follow you
throughout your
lifetime?
Can we study your
tumor using molecular
technology?
Can we recontact you?
Unique Consenting Approach
Electronic Consenting System
Wireless
touch- screen
tablet
Consists of IRB
Approved:
Introductory Video
Connects via
secure interface
and forwards
HIPAA-compliant
information to
database
Consent Video by PI
Informed Consent
Signature Capture
Demographics Survey
Partners in the Fight Against Cancer
Billings Clinic
Lehigh
Valley
Norton Cancer Institute,
Louisville, KY
Total Cancer Care Research Protocol
TCC protocol active at 18 sites with over
69,871 (1) patients consented
Enrolling approx 500 patients/week
9 sites in Florida and 9 sites in other states (NC,
SC, NE, LA, IN, KY, CT, MI, GA)
Tissue biorepository continues to expand
with 22,748 (1) tissue samples collected
16,223
(1)
tumors profiled
Longitudinal data collection
(1) As of 2/4/11
Productivity TCC Consortium
sites led to interests in
capitalizing on this network
CCSG Administrative Supplement
Intended to build linkages w NCCCP
sites
To better attain collaborative goals in
relation to
accrual to trials
collection of quality biospecimens
outreach to underserved populations
Leverage the resources of both
initiatives (CCSG – NCCCP)
Due June 2009
CCSG Administrative Supplement
Awarded September 2009
Partners
Billings Clinic
Hartford Hospital
Aims
Dissemination novel trials – N01
Participation in behavioral and outcomes
research
Capitalize on the Biospecimen processes
NCCCP in Clinical Trial Participation
Hartford (3 trials)
Phase 2 trial in ovarian cancer
Multi-arm Phase 2 trial in OC,
endometrial, HCC, islet cell and
carcinoid tumors
Phase 1/2 trial in breast cancer
Billings (5 trials)
Phase 2 trial in SCC of H&N
Multi-arm Phase 2 trial in OC,
endometrial, HCC, islet cell and
carcinoid tumors
Phase 1/2 trial in breast cancer
Phase 2 trial in myeloma
Phase 1/2 trial of 1-MT/docetaxel in
solid tumors
(NCI CM-62208 N01 Contract: Southeast Phase 2 Consortium)
Clinical Trials Video Evaluation
Internally developed DVD about trials
English and Spanish (trans-created)
Send to new patients
Help to initiate the Dialog about trials
Prior to roll out - validation
Health Outcomes and Behavior Program
Paul Jacobsen, PhD
NCCCP partner participation
Completed - Data under review currently
NCCCP Partnering Lessons Learned
Eagerness to participate in research
Desire a seat at the table in designing
and conducting research
Sophisticated infrastructure in place
which is required to support trials
Focused Hub of trial support
● (Clinical Trials Office)
Centralize Infusion
Critical mass of existing research
NCCCP Partnering Lessons Learned
Robust Health Information Management
systems and willing to invest to linkages
Community practices have unique
challenges in conducting Total Cancer Care
Protocol
Surgical – Medical Oncology Links
Integrating protocol into high volume clinical
operations
BUT it can be done and DONE WELL
One of the best partners to help us realize
personalized cancer care (molecularly
directed)
What’s Next
Trial Matching
TCC Data
3 NCCCP sites and 2 FL based consortuim
members
Identifying trial ready populations
● Breast
● Ovarian
● Lung
What's Next
Capitalize on TCC Network
Patient Data
Molecular Information
New
Type of
Trial
Streamlining Clinical Trials
Traditional Clinical
Trials
~Half the patients
<Half the time
>Response rates
Broad Patient Population
“TurboTrial”
Molecularly Defined
Population
10-12 Years
3-5 Years
Thank you