Download DIA 2010 Annual Meeting

Clinical Trials in the Age of
Personalized Cancer Medicine:
The Evolution of a More
Efficient, Patient Focused
Clinical Research System
Session Chair: Eric Lynam
Vice President Business Development
Pharmatech Oncology Inc.
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46th Annual Meeting
Washington, DC - 2010
2
Session Update
•
•
•
•
Program Substitution – Eric Lynam DH for
Matthew B. Wiener, Pharm.D.
Pharmatech Oncology Founder and COO
Unable to participate today due to injury
46th Annual Meeting
Washington, DC - 2010
Session Learning Objectives
• Define rare cancers by histological and molecular
definitions
• List three challenges in conducting oncology clinical
trials in rare cancers
• Discuss modifications in workflow that enable greater
research efficiency through patient-focused project
management
• Discuss regulatory solutions which permit patient
focused research while providing proper oversight and
patient protection
46th Annual Meeting
Washington, DC - 2010
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Clinical Trials in the Age of
Personalized Cancer Medicine
• ASCO 2009: ‘Personalizing Cancer Care’
• ASCO 2010: ‘Advancing Quality Through
Innovation’
• “Oncology is no longer a one-size-fits-all
medicine" – Richard Schilsky, MD
• "We are increasingly able to tailor treatments to
an individual's or to a tumor's unique biology,
which ultimately helps us to improve outcomes
for patients by matching the right treatment to
the right patient at the right time.“
46th Annual Meeting
Washington, DC - 2010
Challenges to Oncology Clinical
Trials
• US cancer patients are treated in thousands of
independent practices
• Participation is clinical trials remains low (<5%)
• How to connect the right investigational treatments
to the right patients to develop targeted therapies?
• How to deliver investigational treatment options to
more patients within context of patient care?
• How to accelerate research and ensure protection of
patients, in compliance with GCP and CFR 21?
46th Annual Meeting
Washington, DC - 2010
Dr. Jeffrey Vacirca
• Clinical Trials in Oncology: Re-examining
the Site-based Research Paradigm
46th Annual Meeting
Washington, DC - 2010
The Evolution of a More Efficient, Patient
Focused Clinical Research System
• Migration from a site centered system to a
patient and treatment focus
• Patient first system requirements
– Network of qualified, research ready sites
– Identify candidate patients where they present
– Connect patients to appropriate clinical trial treatment
opportunities
– Rapid trial entry – Need to treat in weeks not months
– Logistical Alignment – Site supply, initiation, training
– Full compliance with CFR 21, GCP and all study
oversight measures
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Washington, DC - 2010
Just In Time Research Model
Site Based Research
Protocol
Review
IRB Site
Approval
SQV
Wait for Patients (weeks, months, or more)
Qualify,
Pre-Identify
Consent, &
Patient
Enroll
SIV
Training
Diminishing Study Awareness
Cost & Risk
Patient Based JIT Research
Pre-Identify
Patient
Protocol
Review
IRB Site
Approval
SQV/SIV
Training
Avg. 10 Days
Look for Patients
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Washington, DC - 2010
Qualify,
Consent, &
Enroll
What Makes Just In Time a
Potential Solution?
• Higher throughput patient ID and enrollment rate
– Broader detection by many sites
– Immediate enrollment increases trial enrollment rate
• Alignment of administrative activities to
immediate enrollment opportunities
– No lag between site initiation and first patient consent
• Few or zero non-enrolling sites
– Efficient use of sponsor resources, materials, start up
costs
• Secondary enrollment
– X Factor. High study awareness
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Washington, DC - 2010
JIT Research and Protection of
Human Subjects
• Can research administration be accelerated and
still comply with CFR 21 and GCP?
• Are patient rights properly protected in a JIT
research model?
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Washington, DC - 2010
Matt Baker
• Protecting Patient Rights and Regulatory
Compliance in a Patient-Directed Clinical
Research System
46th Annual Meeting
Washington, DC - 2010
Feasibility Of JIT Research Model
Collaboration Between Sponsor and CRO
Pros
Cons
Eliminate rate limiting steps to activate
sites
High level of coordination needed to
streamline/execute critical steps across crossfunctional groups
Use community-based MD practices where
study subjects are first diagnosed
Sites potentially require more oversight and
training
Decrease time from site initiation to
enrollment
Resources at sponsor and SMO must be
adequate to execute intense pre-initiation
activities
Cost-effective (i.e. sites with no subjects
will not be initiated and monitored)
Potential impact of cost may be difficult to
measure, large# of sites may be qualified but
not initiated
Central IRB, speeds approval of
subsequent protocol/ICF changes
Sites with pre-identified subjects per SoC may
have high screen failure rate, still not enroll
Adapted from S. Gevorkian, F. Patterson PRCT Annual Meeting March 2010
46th Annual Meeting
Washington, DC - 2010
Case Studies
Trial
CML
Traditional
JIT
Pancreatic
Traditional
JIT
Lymphoma
Traditional
JIT
Sites Initiated
Months
Enrollment
Non-Enrolling
Sites
Rate
(Pt/Site-mo)
14
14
23
17
17
18
Several
0
0.052
0.076
16
8
20
7
42
20
2
0
0.13
0.36
24
8
11
9
4
8
20
0
0.015
0.11
46th Annual Meeting
Washington, DC - 2010
Sponsor Conclusions from CML Trial
•
More JIT sites that were opened actually enrolled subjects
•
More than half of total US subjects enrolled came from JIT sites with
few screen failures
•
Streamlined processes decreased time to execute steps to qualify,
initiate, and enroll subjects
•
Model is not ‘one size fits all’: Conduct realistic feasibility assessment
whether right for your therapeutic area, study protocol, and
organization
– Ensure adequate resources are identified and part of study budget
– Buy-in from different groups within the organization is key and should
be sought early in the decision-making process
– Partner with SMO to establish a clear and comprehensive work flow
•
Ensure commitment and planning on both sites to execute deliverables
in a time sensitive and intense environment
S. Gevorkian, F. Patterson PRCT Annual Meeting March 2010
46th Annual Meeting
Washington, DC - 2010
Future Directions: Patient Focused
Oncology Research
• Further R&D –
– Solutions like Just In Time
– Commercial and NIH supported
• Expanded Connectivity
– Trial registries (e.g. ClinicalTrials.gov)
– Patient Matching (e.g. advocacy, enrollment support
organization)
• Systematic Integration
– National healthcare (e.g. NCI, caBIG)
– Patient care - Any patient to any research site
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Washington, DC - 2010
Conclusions - Discussion
• Development of personalized cancer therapies
requires much greater patient participation in US
(5%  20%)
– Greater availability of trials across research practices
– Greater access for individual patients to appropriate
cancer trials
– Meet all regulatory, documentation, and patient protection
commitments
– Alignment of research activities with patient care
needs
– One solution currently in development through Just In
Time method
• Thank you for your participation!
46th Annual Meeting
Washington, DC - 2010