UW Office of Clinical Trials

Chiari Surgical Outcomes Trial
PI: Bermans J. Iskandar and Timothy George
with collaboration from John Kestle
 ASAP-funded pilot study
 Initially suggested by Drs. Mihorat and Batzdorf
 Original plan led by Marcy Speer
 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
Title: Outcomes in Patients Undergoing
Surgical Intervention for Chiari Type 1
Malformation with Syringomyelia
Reasons for Study:
ASAP member survey regarding research
ASPN member survey regarding
Study Goals
Direct goal: To collect pilot data to evaluate
surgical approaches and outcomes in surgery
for patients with Chiari I malformation with
Indirect long-term goals:
To generate preliminary data for a large federallyfunded study
To initiate an organized process/database by
which Chiari and Syringomyelia can be studied in
an objective and consistent manner
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
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)
UW Office of Clinical Trials
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
OCT Services Provided
 Finance
 Administration
 Regulatory compliance
 Clinical study coordination
Typical Trial Process: Step I
 Trials originate from investigators or from
industry sponsors
 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 feasibility review is conducted in
collaboration with the PI
 Protocol is sent to Finance, Regulatory and to
the Clinical Coordinator
Typical Trial Process: Step 2
 Budget is negotiated, pricing is confirmed
and a preliminary budget is prepared
 The Oncore database becomes activated
 Protocol and Subject Life Cycle
 Subject Safety Management
 Protocol and Subject Calendar
 Electronic Data Capture & Data
 Study Information Portal
 Custom Reporting Technology
Typical Trial Process: Step 3
Oncore Database (cont’d)
 Electronic Data Capture & Data
 Study Information Portal
 Custom Reporting Technology
Oncore goal for the Chiari Surgical
Outcomes Study:
 To provide for a seamless transition to a larger trial
Typical Trial Process: Step 4
 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
 Budget is finalized
 Protocol IRB preparation is initiated and
submitted for approvals
Typical Trial Process: Step 5
 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
Chiari Surgical Outcomes Trial
Study Objective: Collect pilot
data to evaluate surgical
approaches and outcomes in
surgery for patients with Chiari
I malformation with
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
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
2010. This went smoothly with no glitches.
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.
Current Study Status
Progress and Complications
No subject has withdrawn.
No subject has completed participation.
No adverse events or protocol violations
No changes in research plan, method or
Future Expectations
We are anticipating a two-year timeline to collect data on
100-120 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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