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
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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