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Clinical Trials


Clinical Trials An Academic Perspective Mohammed Milhem, MD University of Iowa General 3 % of adult cancer patients nationwide enroll in clinical trials each year ... – PowerPoint PPT presentation

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Title: Clinical Trials

Clinical Trials An Academic Perspective
  • Mohammed Milhem, MD
  • University of Iowa

  • 3 of adult cancer patients nationwide enroll in
    clinical trials each year
  • Advances in cancer treatment depend on clinical
  • 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
  • Still not enough

Academic CentersExpectations
  • 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

  • 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
  • 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 National
Clinical Trials
Clinical Trial Approved by Investigator
Clinical Trials Support Core Office
Contract Office Sponsored Programs
Radiation Committee
Study Open For Accrual
TIME 4-6 months
  • 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

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
  • 4 Open studies.

3 clinical
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 Status
OPEN STUDIES 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.
OPEN STUDIES SARC 006 Phase 2 trial of chemotherapy in sporadic and NF type 1 associated with high-grade unresectable MPNST Approved and open to accrual.
AT IRB 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.
AT IRB 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.
On HOLD 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.
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
  • 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
  • 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//
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
  • Perceptions by patients that they are required to
    be in clinical trial

  • Providing more information about trials to the
    community oncologists as well as the prospective
  • 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

  • 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-to-toxic
    ity 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
  • 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
  • Dont try to open every trial
  • Open trials for different tumor populations and
    at different stages of their disease (
  • 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
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