E-125 Impact of COVID related restrictions on clinical trials – Insights from the sterling registry

Abstract

E-125 Table 1Post-COVID differences in actual vs. projected monthly enrollment rates by regionRegion Actual (mean ± SD) Projected(mean ± SD) Mean Diff. 95% CI US 5.92 ± 3.53 9.58 ± 0.51 3.67 1.53;5.80 EU 3.83 ± 2.04 5.83 ± 1.34 2.00 0.54;3.46 Japan 1.25 ± 1.60 2.17 ± 0.39 0.92 -0.07;1.90 Global 3.67 ± 1.61 5.86 ± 0.67 2.19 1.15;3.24 ConclusionThe Covid pandemic has the potential to dramatically alter how research is conducted worldwide. U.S. sites faced tougher restrictions than their EU and Japan counterparts. Particularly within the U.S., moratoriums on research and elective surgery may be the driving factor in reducing overall enrollment and increasing the percentage of ruptured aneurysm enrollment. Fortunately, these changes did not appear to negatively affect occlusion rates or adverse events.DisclosuresR. De Leacy: 6;C;Reports other and non-financial support from Penumbra;and non-financial support from Cerenovus and Siemens. A. Puri: 1;C;Has received research grants from Medtronic Neurovascular and Stryker Neurovascular.. 2;C;Serves as a consultant for Medtronic Neurovascular Stryker Neurovascular. R. Starke: 2;C;Serves as a consultant for for Medtronic Neurovascular, Penumbra, Cerenovus, and Abbott. B. Jankowitz: 2;C;Serves as a consultant for Medtronic and Stryker. A. Yoo: 1;C;Receives research grants from Medtronic, Cerenovus, Penumbra, Stryker, and Genentech. 2;C;Serves as a consultant for Cerenovus, Penumbra, and Zoll.. 4;C;Has equity interest in Insera Therapeutics.. G. Pero: None. C. Chivot: None. T. Yao: 2;C;Serves as a consultant/proctor for Medtronic. O. Zaidat: 2;C;Serves as a consultant for Neuravi, Stryker, Penumbra, and Medtronic.