The new landscape for stroke research. Enrique Leira M.D., M.S. Associate Professor of Neurology University of Iowa PI: UIRCC StrokeNet

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1 The new landscape for stroke research Enrique Leira M.D., M.S. Associate Professor of Neurology University of Iowa PI: UIRCC StrokeNet

2 NIH Randomized Clinical Trials (RCT) POPULATION STUDY Provide best evidence causality Quantifies risk-benefit Best protection against biases Advanced Stroke Care THE POWER OF RANDOMIZATION! ACTIVE TREATMENT CONTROL

3 Challenges for NIH-sponsored Stroke RCTs RCTs are very costly Limited resources ($30-$70 million /yr) Delays peer-review process Too few grants awarded (20-50 phase II-III) Delay building trial Infrastructure Regulatory delays (contracts, IRBs) Delays enrollment Landis & Fisher, Stroke 2013

4 Delayed Enrollment in RCT Loss of Sponsorship & Early Termination Excessively Long Trials Underpowered False Negative Exposing Patients Unnecessary Risk Increased Cost Delay in Obtaining Societal Answers Evolution Intervention & Ancillary Care

5 Evolution Intervention & care PLANNED RECRUITMENT ACTUAL RECRUITMENT

6 Causes Delayed Enrollment RCT Clinical Research is Sporadic work Competing priorities Competing RCT protocols Funding goes to few trial leaders Fixed number of patients around urban tertiary centers Landis & Fisher, Stroke 2013

Distances to research centers Barriers to acute trials

7 Low participation RCT in Rural Areas 25% of the US population Dispersion population Fewer research centers Distances to research centers Barriers to acute trials with short time window Barriers to prevention/recovery trials

8 Potential Solutions RCTs Increased capture patients from real world, particularly rural areas Expand pool researchers Motivate clinical investigators Coordinate basic and clinical scientists Established dedicated research teams and infrastructure Harmonized research capable of Metadata analysis Landis & Fisher, Stroke 2013

9 NIH Stroke Trial Network 25 Regional Centers supported by a central coordinating center Established permanent structure of researchers Foster interdisciplinary collaboration for translational research Train translational scientists in stroke Efficiency in performing trials Accept central IRB and master agreements

10 The University of Iowa Statewide Stroke Research Network (1U10NS ) Aim 1: Establish the University of Iowa Regional Coordinating Center (UIRCC) as a statewide research network for improving subject recruitment for NINDS-funded and other stroke trials. Aim 2: Develop innovative translational research proposals that will lead to multicenter clinical trials through the NINDS stroke network.

Chickasaw Fayette Clayton Plymouth Cherokee Buena Vista Pocahontas Humboldt Wright Franklin Butler Bremer Trial-Ready Hospital ( # patients/year) 1. Mercy, Sioux City (381/year) 2. St.

Allen Hospital, Waterloo (200/year) 8. Mercy, Cedar Rapids (220/year) 9. St. Luke s, Cedar Rapids (125/year) 10. Mercy, Iowa City (165/year) 11. Genesis, Davenport (204/year) 12.

12 Fig 1. UIRCC Statewide Stroke Trials Infrastructure Lyon Osceola Dickinson Emmet Kossuth Winnebago Worth Mitchell Howard Winneshiek Allamakee Sioux O Brien Clay Palo Alto Hancock Cerro Gordo 3 Floyd Chickasaw Fayette Clayton Plymouth Cherokee Buena Vista Pocahontas Humboldt Wright Franklin Butler Bremer Trial-Ready Hospital ( # patients/year) 1. Mercy, Sioux City (381/year) 2. St. Luke s, Sioux City (70/year) 3. Mercy, Mason City ( 300 /year) 4. Methodist, Des Moines (288/year) 5. Mercy, Des Moines (740/year) 6. Mary Greely, Ames (140/year) 7. Allen Hospital, Waterloo (200/year) 8. Mercy, Cedar Rapids (220/year) 9. St. Luke s, Cedar Rapids (125/year) 10. Mercy, Iowa City (165/year) 11. Genesis, Davenport (204/year) 12. Great River, Burlington (109 /year). UICSC (900/year) TOTAL: 3842 acute stroke patient/yr 1 2 Woodbury Ida Sac Calhoun Monona Crawford Carroll Greene Harrison Shelby Audubon Guthrie Webster Dallas Boone Hamilton Hardin Grundy Black Hawk Story Marshall Tama Benton Linn Polk Jasper Poweshiek 4 5 Buchanan Delaware Dubuque Iowa Johnson Cedar Pottawattamie Cass Adair Madison Warren Marion Mahaska Keokuk Washington Mills Montgomery Adams Union Clarke Lucas Monroe Wapello Jefferson Fremont Page Taylor Ringgold Decatur Wayne Appanoose Davis Van Buren Henry Lee Jones Muscatine Louisa Des Moines 12 Jackson Clinton Scott 11 Fig 1A. Stroke Hospitalization Rates by County miles Map Legend = UI Comprehensive Stroke Center (UICSC) = Stroke Trial-capable Hubs rehabilitation units (n=12) = Critical Access Spoke Hospitals (N=82) =Other Spoke Hospitals (N=21) = Aeromedical Transport Base

15 Opportunity for the State of Iowa Contribute to advance stroke research (acute trials, prevention, and recovery) Facilitate promising translational research and clinical trials with community input Advocates for rural stroke care Potential for helping recruitment by expanding pool subjects Generalize stroke trials to real life rural patients

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Beef Research Report, 199 Animal Science Research Reports 199 A Survey of Forage Quality Following a Flood Year: 199 Daryl R. Strohbehn Iowa State University Follow this and additional works at: http://lib.dr.iastate.edu/beefreports_199