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ADAPTABLE The Aspirin Study CDRN Update
12 Jun 2017
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Site Activation & Enrollment Update (6/12)
29 Sites Currently Active, 27 have enrolled 86,123 of 393,682 of total eligible approached 6,914 Golden Tickets Entered into the Patient Portal 3,220 Subjects Randomized Current enrollment 33% of Projected enrollment for June 2017 Retention 3,068 Week 1 Visits Expected: 2,444 Complete (80%), 626 Total Late (20%), 229 >90 days Late (7%) 782 3mo Visits Expected: 554 Complete (71%), 234 Total Late (30%), 94 >90 Days (12%) 661 6 Month Visits Expected: 490 Completed (74%), 175 Total Late (26%), 55 >90 Days Late (8%)
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Site Approach & Enrollment Update (6/12)
CDRN Site Total Number Eligible Total Number Approached % of Eligible Approached Golden Tickets Entered % Golden Tickets entered per Approached Total Enrolled # Non-internet Enrolled % Enrolled Per Approached % Enrolled Per Golden Ticket Entered Enrolled last week MidSouth Vanderbilt 22,271 7,879 35% 1,198 15% 647 20 8% 54% 19 Mid-South Duke 20,127 1,236 6% 518 42% 387 71 31% 75% 23 PaTH UPMC 13,879 8,682 63% 1,078 12% 341 4% 32% REACHnet Ochsner 11,832 6,941 59% 646 9% 251 46 39% 6 OneFlorida U of Florida 29,738 3,110 10% 250 195 36 78% 9 NYC-CDRN Montefiore 53,151 2,366 204 166 67 7% 81% 10 Penn St 5,246 3,885 74% 441 11% 149 34% 7 Utah 5,219 5,945 114% 294 5% 132 14 2% 45% 3 GPC Iowa 11,391 5,328 47% 280 KUMC 4,209 4,024 96% 285 127 3% 2 MCW 12,220 6,108 50% 345 119 Marshfield Clinic 8,277 6,083 73% 191 96 5 CAPriCORN Northwestern 6,697 5,754 86% 176 82 1% pScanner UCLA 15,669 5,229 33% 75 U of Chicago 5,446 574 77 13% 72 41 94% 1 BSW 2,431 2,220 91% 134 45 Weill Cornell 5,856 893 138 42 30% NYU 31,795 1,126 142 32 23% Temple 6,522 4,989 76% 126 30 24% Rush 8,826 1,365 56 28 Mt Sinai 15,832 483 53 38% UTSW 2,459 522 21% 17 57% UNC 5,204 533 43 16 37% Missouri 1,204 617 51% 29 Tulane 771 124 16% 18 4 22% Nebraska 3,475 102 40% Johns Hopkins 23,935 0% 60% 20% TOTAL 333,682 86,123 26% 6,914 3220 333
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Monthly Enrollment (6/12)
2016 Site Apr 2016 May 2016 Jun 2016 Jul 2016 Aug 2016 Sep 2016 Oct 2016 Nov 2016 Dec 2016 Total Enrolled 8 32 22 50 77 90 171 163 151 # of Sites Approaching 2 4 6 10 14 16 Total Approached 126 381 380 1,196 1,920 2,342 7,499 4,160 7,299 2017 Site Jan 2017 Feb 2017 Mar 2017 Apr 2017 May 2017 Jun 2017 Total Enrolled 294 362 448 600 610 142 # of Sites Approaching 17 22 23 26 27 Total Approached 4,455 10,185 13,353 14,159 14,662 2,233 keep
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ADAPTABLE Trial Enrollment Details
Follow us on ClinicalTrials.gov: NCT
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ClinicalTrials.gov: NCT02697916
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ADAPTABLE Enrollment Projections by CDRN (6/12)
16-Apr 16-May 16-Jun 16-Jul 16-Aug 16-Sep 16-Oct 16-Nov 16-Dec 17-Jan 17-Feb 17-Mar 17-Apr 17-May 17-Jun PaTH Projected 25 75 100 125 150 175 Actual 19 14 33 34 101 49 122 95 144 17 % 0% 76% 19% 33% 34% 81% 39% 63% 82% 10% GPC 8 1 16 31 10 117 54 141 108 18 32% 1% 21% 31% 8% 94% 36% 62% pSCANNER 50 2 26 12 4 3% 35% 12% 7% NYCDRN 37 24 61 68 43 16% 37% 24% 41% 45% 29% ReachNET 20 23 28 36 32 9 4% 64% 72% 40% 23% 28% 15% 17% 18% 5% Mid-South 7 29 38 97 46 72 109 183 208 62 128% 58% 38% 97% 26% 48% 67% 73% 122% 119% CAPriCORN 5 3 42 11 1 Florida 200 27 112% 124% 13% Total 225 450 500 700 925 950 1150 1175 1325 1400 22 77 90 171 163 151 294 362 448 600 610 142 44% 20% 22% 51% 46% Cumulative 275 1450 2150 2850 3775 4725 5875 7050 8375 9775 40 112 189 279 613 764 1058 1420 1868 2468 3078 3220 27% 30%
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Site Enrollment Average (6/12)
CDRN Site Site Activated Started Enrollment Total Enrolled Enrollment Rate/Month Mid-South Duke 11/9/2016 November 387 55.3 Vanderbilt 4/18/2016 April 647 46.3 PaTH UPMC 7/18/2016 August 341 34.1 OneFlorida U of Florida 11/1/2016 195 27.9 GPC Marshfield Clinic February 96 24.0 MCW January 119 23.8 NYC-CDRN Montefiore 166 23.7 Penn State 9/23/2016 October 149 18.6 KUMC 127 18.1 CAPriCORN U of Chicago 2/16/2017 72 18.0 REACHnet Ochsner 251 17.9 Utah 132 16.5 Weill Cornell 3/8/2017 March 42 14.0 Iowa 13.2 pScanner UCLA 11/7/2016 75 10.7 Northwestern 8/30/2016 September 82 9.1 UNC 1/13/2017 16 8.0 Rush 9/19/2016 28 7.0 Mt Sinai 12/21/2016 20 6.7 UTSW 17 5.7 BSW 45 5.6 NYU 32 4.6 Temple 30 3.8 Missouri 10 3.3 Nebraska 4 2.0 Johns Hopkins 8/31/2016 June 1 1.0 Tulane 0.5
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ADAPTABLE Follow-up Visits (6/12)
CDRN Site Golden Tickets Entered Randomized Early Visit (Expected) Early Visit (Completed) Early Visit (< 31 Days) Early Visit (31-60 Days) Early Visit (61-90 Days) Early Visit (> 90 Days) CAPriCORN Northwestern Medical 176 82 74 59 4 3 Rush 56 28 27 25 2 U of Chicago 77 72 71 60 5 GPC University of Iowa 280 132 131 117 1 13 KUMC 285 127 123 104 8 10 Medical College of Wisconsin 345 119 110 79 20 Marshfield Clinic 192 96 84 66 University of Texas Southwestern 30 17 15 University of Missouri 29 University of Nebraska Med Ctr Mid-South Vanderbilt University 1200 648 610 530 39 Duke 518 387 365 272 23 UNC Chapel Hill 44 16 12 NYC CDRN New York University 143 32 Montefiore Medical Center 205 166 159 97 11 18 Mount Sinai Health System 54 14 Weill Cornell Medical College 138 42 6 OneFlorida University of Florida Gainesville 250 195 184 9 35 PaTH University of Pittsburgh 1078 341 339 253 19 Temple University 126 University of Utah 294 109 Penn State University 441 149 140 107 Johns Hopkins pSCANNER UCLA 75 73 62 REACHnet Ochsner 646 251 247 217 Baylor Scott and White 134 45 41 33 Tulane Total 6921 3221 3068 2444 169 136 92 229 626 late Week 1 visits
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ADAPTABLE Follow-up Visits (6/12)
3 Month Visit 6 Month Visit CDRN Site Expected Completed < 31 Days 31-60 Days 61-90 Days > 90 Days CAPriCORN Northwestern Medical 21 18 1 24 20 Rush 4 3 U of Chicago 7 GPC University of Iowa 49 39 5 2 29 25 KUMC 27 16 11 MCW 17 14 Marshfield Clinic UTSW University of Missouri Nebraska Mid-South Vanderbilt University 194 151 6 289 231 23 13 Duke 79 50 UNC Chapel Hill NYC CDRN NYU Montefiore Medical Center 38 Mt Sinai Weill Cornell OneFlorida U of FL Gainesville 75 8 9 40 15 PaTH University of Pittsburgh 70 55 43 Temple University University of Utah 35 28 19 Penn State University 33 26 Johns Hopkins pSCANNER UCLA 22 REACHnet Ochsner 83 121 86 Baylor Scott and White Tulane Total 782 554 64 41 94 661 490 51 234 3mo visits late, 175 6mo visits late
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Standing Reminders
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CDRN and 1:1 Call Schedule
May 1= All CDRN Call July 3= No Calls, July 4th week May 8= NYC-CDRN July 10= All CDRN Call May 15= CAPriCORN July 17= pSCANNER May 22= GPC CDRN July 24= NYC May 29= No Calls, Memorial Day July 31= CARriCORN June 5= All CDRN Call August 7= All CDRN Call June 8= PaTH August 14= NYC-CDRN June 12= OneFlorida August 21= CAPriCORN June 19= REACHnet August 28= GPC CDRN June 26= Mid-South
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CDRN Responsibilities
Create milestones for trial execution for every site Facilitate execution of contracts, IRB approvals Submit requested updates to CC on time Review and approve local site patient recruitment plans Follow up on any missed timelines and create work plans for catching up Escalate operational issues to CDRN PI regarding any site not meeting timelines and deliverable expectants
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CDRN Order of Priorities
Approach and Enrollment at active sites Activate remaining sites Datamart Refresh Response to ADAPTABLE queries
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CDRN Recurring Deliverables
Bi-Weekly: New Approaches/week by site Missed Early Visit Check-in spreadsheet (aggregate data) Site Metrics update Monthly: All CDRN Call Bi-Monthly: 1:1 CDRN call with CC Ad-Hoc: Updated eligibility numbers from CP Updated team directory Reconcile Golden Ticket with CDM
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