Download presentation
Presentation is loading. Please wait.
1
ADAPTABLE The Aspirin Study CDRN Update
27 Mar 2017
2
Site Activation & Enrollment Update (3/27)
28 Sites Currently Active, 24 have enrolled 3,757 Golden Tickets Entered into the Patient Portal 1,756 Subjects Randomized Current enrollment 29.9% of Projected enrollment at end of March 2017 Retention 1582 Week 1 Visits Expected: 1278 Complete (81%), 304 Total Late (19%), 96 >90 days Late (6%) 372 3mo Visits Expected: 258 Complete (69%), 114 Total Late (31%), 38 >90 Days (10%) 258 6 Month Visits Expected: 186 Completed (73%), 72 Total Late (28%), 19 >90 Days Late (7%)
3
Site Approach & Enrollment Update (3/27)
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 18,440 5,993 33% 780 13% 406 7 7% 52% 5 REACHnet Ochsner 11,832 5,287 45% 490 9% 188 30 4% 38% PaTH UPMC 13,879 3,286 24% 579 18% 186 6% 32% 12 Mid-South Duke 19,902 485 2% 246 51% 169 22 35% 69% 23 OneFlorida U of Florida 29,738 4,414 15% 146 3% 135 92% GPC Iowa 5,271 5,274 100% 222 109 6 49% Penn St 2,708 2,647 98% 254 10% 87 34% 4 NYC-CDRN Montefiore 47,383 1,192 101 8% 84 38 83% Utah 5,219 3,362 64% 181 5% 77 43% 1 pScanner UCLA 15,669 4,954 123 60 1% KUMC 12,936 1,621 112 52 46% CAPriCORN Northwestern 15,234 2,579 17% 76 40 53% 9 MCW 5,731 2,741 48% 98 37 BSW 2,081 1,486 71% 66 27 2 41% U of Chicago 5,446 489 14 96% NYU 49,254 639 104 16% 21 20% 3 Temple 4,101 889 22% 13 Marshfield Clinic 8,277 216 24 11% 10 42% Rush 8,826 740 19 8 Missouri 1,004 437 44% 16 Mt Sinai 41,876 100 0% 19% Weill Cornell 17,253 23% UTSW 2,459 Tulane 771 17 29% 60% Nebraska 3,200 TOTAL 345,290 49,203 14% 3,757 1756 159 47%
4
Site Enrollment Average (3/27)
CDRN Site Site Activated Started Enrollment Total Enrolled Enrollment Rate/Month Mid-South Duke 11/9/2016 November 169 42.3 MidSouth Vanderbilt 4/18/2016 April 406 36.9 OneFlorida U of Florida 11/1/2016 135 33.8 PaTH UPMC 7/18/2016 August 186 26.6 CAPriCORN U of Chicago 2/16/2017 February 22 22.0 NYC-CDRN Montefiore 84 21.0 GPC MCW January 37 18.5 Penn State 9/23/2016 October 87 17.4 REACHnet Ochsner 188 17.1 Iowa 109 15.6 Utah 77 15.4 pScanner UCLA 11/7/2016 60 15.0 KUMC 52 13.0 Marshfield Clinic 10 10.0 Rush 9/19/2016 8 8.0 Northwestern 8/30/2016 September 40 6.7 Missouri 12/21/2016 March 6 6.0 Mt Sinai BSW 27 5.4 NYU 21 5.3 Weill Cornell 3/8/2017 5 5.0 UTSW Temple 13 2.6 Tulane 3 0.6
5
ADAPTABLE Enrollment Projections by CDRN (3/27)
1 2 3 4 5 6 7 8 9 10 11 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 PaTH Projected 25 75 100 125 150 Actual 19 14 38 30 91 54 92 GPC 16 31 111 42 pSCANNER 50 26 NYCDRN 35 24 44 ReachNET 18 20 23 28 22 Mid-South 33 39 97 51 63 102 95 CAPriCORN 1 Florida 29 32 Total 225 450 500 700 925 950 1150 76 171 175 139 263 366 362 Cumulative 275 1450 2150 2850 3775 4725 5875 40 62 113 189 280 451 626 765 1028 1394 1756
6
ClinicalTrials.gov: NCT02697916
7
ADAPTABLE Follow-up Visits (3/27)
CDRN Site Randomized Completed <31 Days 31-60 Days 61-90 Days >90 Days C11 PaTH Penn State University 87 58 3 4 6 8 Temple University 13 2 1 University of Pittsburgh 186 110 12 University of Utah 77 67 C13 OneFlorida University of Florida Gainesville 135 92 9 18 C2 Mid-South Duke 169 108 21 Vanderbilt University 406 348 7 5 31 C3 pSCANNER University of California Los Angeles 60 46 C4 GPC Marshfield Clinic 10 Medical College of Wisconsin 37 26 University of Iowa 109 90 University of Kansas Medical Center 52 42 University of Missouri University of Nebraska Med Ctr . University of Texas Southwestern C6 REACHnet Baylor Scott and White 27 16 Ochsner 188 154 Tulane C8 NYC CDRN Montefiore Medical Center 84 Mount Sinai Health System New York University Langone Medical Center C9 CAPriCORN Northwestern Medical 40 Rush U of Chicago 22 TOTAL 1751 1278 33 105 304 late Week 1 visits
8
ADAPTABLE Follow-up Visits (3/27)
3 Month Visit 6 Month Visit CDRN Site Expected Completed <31 Days 31-60 Days 61-90 Days >90 Days C11 PaTH Penn State University 14 11 2 1 Temple University 3 University of Pittsburgh 29 19 5 33 24 4 University of Utah 10 7 C13 OneFlorida University of Florida Gainesville 30 13 C2 Mid-South Duke Vanderbilt University 155 125 9 12 127 99 C3 pSCANNER University of California Los Angeles 8 C4 GPC Marshfield Clinic Medical College of Wisconsin University of Iowa 6 University of Kansas Medical Center University of Missouri University of Nebraska Med Ctr University of Texas Southwestern C6 REACHnet Baylor Scott and White Ochsner 65 36 76 47 Tulane C8 NYC CDRN Montefiore Medical Center Mount Sinai Health System New York University Langone Medical Center C9 CAPriCORN Northwestern Medical 16 15 Rush U of Chicago TOTAL 372 258 35 17 38 186 25 114 3mo visits late, 72 6mo visits late
9
Standing Reminders
10
CDRN and 1:1 Call Schedule
Feb 6= All CDRN Call April 3= All CDRN Call Feb 13= pScanner April 10= REACHnet Feb 20= No Calls, President’s Day April 17= Mid-South Feb 27= NYC-CDRN April 24= pScanner March 2= PaTH CDRN May1= All CDRN Call March 6= All CDRN Call May 8= NYC-CDRN March 13= CAPriCORN May 15= CAPriCORN March 20= GPC CDRN May 22= GPC CDRN March 27= OneFlorida May 29= No Calls, Memorial Day
11
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
12
CDRN Order of Priorities
Approach and Enrollment at active sites Activate remaining sites Datamart Refresh Response to ADAPTABLE queries
13
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
Similar presentations
