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Chiari Surgical Outcomes Trial PI: Bermans J. Iskandar and Timothy George with collaboration from John Kestle ASAP-funded pilot study ASAP-funded pilot.

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Presentation on theme: "Chiari Surgical Outcomes Trial PI: Bermans J. Iskandar and Timothy George with collaboration from John Kestle ASAP-funded pilot study ASAP-funded pilot."— Presentation transcript:

1 Chiari Surgical Outcomes Trial PI: Bermans J. Iskandar and Timothy George with collaboration from John Kestle ASAP-funded pilot study ASAP-funded pilot study Initially suggested by Drs. Mihorat and Batzdorf Initially suggested by Drs. Mihorat and Batzdorf Original plan led by Marcy Speer Original plan led by Marcy Speer Study supported by the American Society of Pediatric Neurosurgeons (ASPN) Study supported by the American Society of Pediatric Neurosurgeons (ASPN) The University of Wisconsin (UW) Office of Clinical Trials is providing scientific, clinical and financial support in a collaborative effort to bring this trial to a successful completion The University of Wisconsin (UW) Office of Clinical Trials is providing scientific, clinical and financial support in a collaborative effort to bring this trial to a successful completion

2 Title: Outcomes in Patients Undergoing Surgical Intervention for Chiari Type 1 Malformation with Syringomyelia Reasons for Study: ASAP member survey regarding research needs ASPN member survey regarding methodology

3 Study Goals Direct goal: To collect pilot data to evaluate surgical approaches and outcomes in surgery for patients with Chiari I malformation with Syringomyelia Indirect long-term goals: To generate preliminary data for a large federally- funded study To initiate an organized process/database by which Chiari and Syringomyelia can be studied in an objective and consistent manner

4 Study Methods Prospective, multicenter trial Surgeons follow their own routine in diagnosis, decision, and treatment Primary endpoint Syrinx size postop Secondary endpoints Symptom resolution Cine MRI and other radiographic outcomes

5 Method Rigor and Minimizing Bias Independent reviewers: Committee of 3 (2 surgeons, one neuroradiologist) evaluate all scans blindly Participating Centers: Neither ASAP Board members nor managing centers (Wisconsin, Texas, Utah) were allowed to participate in patient recruitment Data gathering and study coordination: All managed by a professional office with experience in clinical trials - The UW Office of Clinical Trials (OCT)

6 UW Office of Clinical Trials (OCT) Provide professional clinical trial research experience and support to any investigator who requires additional expertise to bring a trial from a collaborative initiation to a successful completion

7 OCT Services Provided Finance Finance Administration Administration Regulatory compliance Regulatory compliance Clinical study coordination Clinical study coordination

8 Typical Trial Process: Step I Trials originate from investigators or from industry sponsors Trials originate from investigators or from industry sponsors A Confidential Disclosure Agreement (CDA) may be initiated A Confidential Disclosure Agreement (CDA) may be initiated A Clinical Trials Agreement (CTA) is executed and routed through our university system to obtain institutional approvals A Clinical Trials Agreement (CTA) is executed and routed through our university system to obtain institutional approvals A feasibility review is conducted in collaboration with the PI A feasibility review is conducted in collaboration with the PI Protocol is sent to Finance, Regulatory and to the Clinical Coordinator Protocol is sent to Finance, Regulatory and to the Clinical Coordinator

9 Typical Trial Process: Step 2 Budget is negotiated, pricing is confirmed and a preliminary budget is prepared Budget is negotiated, pricing is confirmed and a preliminary budget is prepared The Oncore database becomes activated The Oncore database becomes activated Protocol and Subject Life Cycle Management Protocol and Subject Life Cycle Management Subject Safety Management Subject Safety Management Protocol and Subject Calendar Management Protocol and Subject Calendar Management Electronic Data Capture & Data Management Electronic Data Capture & Data Management Study Information Portal Study Information Portal Custom Reporting Technology Custom Reporting Technology

10 Typical Trial Process: Step 3 Oncore Database (contd) Electronic Data Capture & Data Management Electronic Data Capture & Data Management Study Information Portal Study Information Portal Custom Reporting Technology Custom Reporting Technology Oncore goal for the Chiari Surgical Outcomes Study: To provide for a seamless transition to a larger trial To provide for a seamless transition to a larger trial

11 Typical Trial Process: Step 4 PI signs Office of Clinical Trials agreement and it is executed PI signs Office of Clinical Trials agreement and it is executed Clinical coordinator prepares the source documents and data collection forms for entry into the Oncore database Clinical coordinator prepares the source documents and data collection forms for entry into the Oncore database Budget is finalized Budget is finalized Protocol IRB preparation is initiated and submitted for approvals Protocol IRB preparation is initiated and submitted for approvals

12 Typical Trial Process: Step 5 IRB study approval is obtained and a recruitment plan is created IRB study approval is obtained and a recruitment plan is created A final meeting is scheduled with the PI to confirm accrual, recruitment and accountability A final meeting is scheduled with the PI to confirm accrual, recruitment and accountability

13 Chiari Surgical Outcomes Trial Study Objective: Collect pilot data to evaluate surgical approaches and outcomes in surgery for patients with Chiari I malformation with Syringomyelia Study Objective: Collect pilot data to evaluate surgical approaches and outcomes in surgery for patients with Chiari I malformation with Syringomyelia

14 Current Chiari Trial Status Setup and IRB UW School of Medicine and Public Health received IRB approval to be the data collection site for this study on 5/4/2009. Our site has IRB approval to collect data from up to 12 clinical sites, 120 total subjects, no more than 10 subjects per clinical site. Oncore research database is complete and we are able to enter the data as we receive it. We ran a test subject through the data collection process March This went smoothly with no glitches.

15 Current Study Status Enrollment to-date We currently have three active clinical sites who have signed Clinical Trials Agreements with our institution and their own IRB approvals are in place. Six clinical sites are in the clinical trials agreement negotiation process. Four enrolled subjects at this time.

16 Current Study Status Progress and Complications No subject has withdrawn. No subject has completed participation. No adverse events or protocol violations reported. No changes in research plan, method or investigators.

17 Future Expectations We are anticipating a two-year timeline to collect data on subjects We anticipate collecting enough information to achieve the following goals: Publish a feasibility study that would facilitate obtaining NIH funding for a large study Provide preliminary but publishable data on differences in outcome between the 3 procedures to decompress a Chiari I


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