Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
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