Transcript Document

Clinical Trials –
An Academic Perspective
Mohammed Milhem, MD
University of Iowa
General
• 3 % of adult cancer patients nationwide
enroll in clinical trials each year
• Advances in cancer treatment depend on
clinical trials
• Barriers to treatment are both patient
related and physician related
University of Iowa
• Last year saw 3,274 new cancer
patients
• 278 cancer patients were placed on
treatment clinical trials
• Accrual rate 8.5%
• Clinical Trials Support Core supports
21 oncologists
• Still not enough
Academic Centers—Expectations
•
•
•
•
•
•
Investigator initiated trials
Capabilities of translational research
Capacity for a phase I, II, III trials
Access to diverse group of patients
Access to complex patients
Access to National Groups
Limitations—Funding
• A recent survey of 122 major academic
medical centers in the US revealed that
79% of all clinical trials were sponsored by
private industry, and 76% of funding for
clinical investigations came from private,
for-profit companies
• It is unlikely that this trend of increasing
industry-supported clinical research will
reverse or even slow down
• Slow process to get trial up and running
Investigator initiated
Industry
Clinical Trials
National
Clinical Trial
Approved by
Investigator
Clinical Trials Support
Core Office
Contract Office
Radiation
Committee
IRB
PRMC
Sponsored
Programs
Study Open For
Accrual
TIME === 4-6 months
PRMC
•
•
•
•
Peer Review and Monitoring Committee
Once a month meeting
10 trial limit, first come first serve
Cooperative group studies undergo an
administrative meeting
• Industry and investigator initiated undergo
a scientific meeting
• Investigator initiated trials take the longest
time
Sarcoma Related Trials
• Rare tumor-need of a centralized system
• Last year no sarcoma trials, no patients
accrued on trials
• University of Iowa joins SARC
• 2 clinical trials obtained from this national
group currently open at the University
• 2 industry sponsored trials open and actively
accruing patients
• 1 Cancer Center supported investigator
initiated trial for sarcoma tissue banking
Clinical Studies
ARIAD= 4 pts
3 clinical
• 4 Open studies.
Yondelis= 1pt
SARC 006= 0 pt
1 collection study
• 3 Pending studies
• 2 Studies under consideration
• 2 Pediatric trials open for bone sarcomas
• 1 Study on hold
Clinical Research Program
Study Title
ARIAD
A Pivotal Trial to Determine the Efficacy and Safety of
AP23573 when Administered as Maintenance
Therapy to Patients with Metastatic Soft-Tissue or
Bone Sarcomas
Approved and open to accrual.
SARC 006
Phase 2 trial of chemotherapy in sporadic and NF type 1
associated with high-grade unresectable MPNST
Approved and open to accrual.
Schering
Plough
Study to determine activity of SCH717454 in subjects with
osteosarcoma or Ewing's than has relapsed after
standard therapy
Submitted to WIRB 9/23/08. Awaiting review.
SARC 009
A Phase II Trial of Dasatinib in Advanced Sarcoma
Waiting for final PRMC approval, then study will
be scheduled for IRB meeting.
Pfizer
A6181112
Phase IIIB Randomized, Active Controlled Open-Label
Study of Sunitinib 37.5 mg daily vs. Imatinib
Mesylate 800 mg daily in the treatment of Patients
with GIST who have had progressive disease while
on 400 mg daily of Imatinib
Have protocol.
Pfizer
6181155
A Randomized Phase II Open Label Trial of Sunitinib
Malate vs Imatinib Mestlate in the First Line
Treatment of Patients with Unresectable or Metastatic
Malignant GIST
Pfizer put this study on hold for now.
OPEN
STUDIES
AT IRB
On HOLD
Status
System Barriers
•
•
•
•
•
•
•
Slow process ~ not efficient
High start up fees
Meet more frequently is difficult
Need more reviewers for the PRMC
More clinical trial support core employees
? Is It faster in the private sector
? Investigator initiated trials
Barriers ~
Patient Related Issues
• Logistic factors such as driving distance or time
demands
• Concerns about being treated at a university
center and of losing continuity with their primary
oncologist
• The relationship with their primary oncologist was
of very high importance to elderly patients
Physician-Related Barriers
• The potential presence of co-morbid conditions
aside from those excluded by the protocol
• Anticipating that older patients would have
difficulty understanding the requirements of a
clinical trial
• The logistics and time involved in enrolling older
patients onto clinical trials
Barriers to Minority Group Participation
in Cancer Clinical Trials








Mistrust-confusion between medical care and
research
Lack of awareness
Lack of invitation
Cultural beliefs
Eligibility criteria/comorbid conditions
Cost/lack of insurance
Language/linguistic differences
Physician lack of awareness
Intercultural Cancer Council. Cancer Clinical Trials: Participation by Underrepresented Populations
http://iccnetwork.org/cancerfacts/cfs11.htm
Barriers to True Voluntary
Participation
• Desire on the part of patient to please
a family member or physician
• A feeling by the patient that no other
options exist
• Perceptions by patients that they are
required to be in clinical trial
Solutions
• Providing more information about trials to the
community oncologists as well as the prospective
enrollees
• Creating more supportive systems to help patients
navigate the complex terrain leading to a clinical
trial especially for elderly patients
• Mechanisms to facilitate the ability of the primary
oncologist to deliver such a trial via a network
approach-constant communication
• Experience with SARC as a national program for
being a designated site
Solutions
• Another potential mechanism for enhancing
enrollment, and one certainly consistent with the
overall goals of oncology, would be to seek
treatments that have a higher therapeutic-totoxicity ratio
• Oral medications, easier to give, better models.
Example: ARIAD maintenance study
• Trials that are easy to administer, require less
frequent visits and are not cumbersome for the
patient
• Actively engage with the patient on trial to help
maintain the trust
Better Utilization of Resources
• Select trials that have been open for a while
• Don’t try to open every trial
• Open trials for different tumor populations and at
different stages of their disease ( complimentary)
• Continually assess trial status – if not accruing
close it
• Replace trials that accrued well, as this is serving
an active population
• Co-ordinate in network the opening of trials
Thank You
Grant Wood
Fall Plowing