GARFIELD-VTE South Africa I nvestigators’ Meeting Johannesburg, 28 th October 2017
Operational Priorities and South Africa Status Update Elizabeth Demmisse Regional Project Manager Thrombosis Research Institute
Operational Priorities South Africa Status Update Follow up- Data entry Recent eCRF Update Query Status Payment process/update Patient retention update and process Communication- Website South Africa specific Challenges- for discussion
South Africa Enrolment Status 100 National Coordinator Investigator: 90 Total=416 86 Prof Barry Jacobson 82 Dr Clifford Smith 80 70 70 National Care Setting: 60 Smaller private hospitals/ rehabilitation 50 clinics 14% 40 40 Other (private angiology practices) 53% 30 30 Large Hospitals / Academic facilities 33% 30 26 18 sites initiated and 14 active sites 20 12 416 patients recruited 10 10 10 10 4 4 2 0 ZAF0079 ZAF0121 ZAF0102 ZAF0067 ZAF0061 ZAF0357 ZAF0063 ZAF0078 ZAF0065 ZAF0080 ZAF0322 ZAF0323 ZAF0355 ZAF0404
South Africa - Patient Milestone 450 0 0 0 15 19 400 52 350 203 300 241 250 416 416 416 416 416 401 200 397 364 150 213 100 175 50 0 Baseline 3M 6M 12M 24M Complete Incomplete Due Not due
South Africa-Query status 90 83 80 Total=158 70 60 50 40 30 20 13 12 11 10 9 8 10 4 4 3 1 0 ZAF0121 ZAF0102 ZAF0065 ZAF0323 ZAF0079 ZAF0322 ZAF0357 ZAF0061 ZAF0355 ZAF0080 ZAF0078
Recent eCRF Update Extra information • Update follow- up pages • Updated Event folder • Treatment Page – Other Treatments • Enhanced Recurrent VTE page • Other Updates • Messaging • Locking Milestones • Queries • ELearning/certificate • Library • Source Data Verification (*visible to monitors only)
Locking Milestone
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Recent System Update
Recent System Update
Recent System Update
South Africa Patient and Site Retention Status How many sites initiated South Africa Patient Withdrawn Status and activated? =18 How many sites dropped Withdraw Consent 7 before recruitment= 4 How many patients Patients NLM 3 recruited? =416 How many LTF 46 withdrawn?=114 Withdrawal rate= 27.4% death LTF= 11% 58 Total no. patiens 114 withdrawn 0 20 40 60 80 100 120
Phase II - On-site Monitoring Phase II planning starts Onsite Patient/site Phase I Audit selection using risk Monitoring Report will be based score and will start end available random selection of October Training CRA Sites will be informed Phase Start Date Cohort Countries *No. of Sites No. of cases Variables SDV’d Total Cases to per site be SDV’d 1 Sep- 16 C1,C2 All, except **Brazil, 42 (~10%) 6-10 100% SDV on first patient data 400 (40%) Mexico, UAE following by partial SDV (Critical Variable) 2 OCT- 17 C1,C2 All 32 (~7%) 6-10 partial SDV (Critical Variable) 300 (30%) 3 OCT- 18 C1,C2 All 32 (~7%) 6-10 partial SDV (Critical Variable) 300 (30%)
BioClinica (Clinverse) Contact details • Sending Invoices to Bioclinica/Clinverse- Please DO NOT send Patients detail with Invoices • Please send all Garfield VTE-related invoices directly to flsinvoices@bioclinica.com • For questions about invoices and/or status of payments, you can access 24/7 support via email at helpdesk@bioclinica.com • or via phone at 1-888-ASK-BIOC (1-888-275-2462) . • Please Include these details in your email to helpdesk@bioclinica.com Vendor Name: {enter Institution or PI name} Site: {enter USA#### where the first three letters are US code and #### is the number} PI: {enter PI name] Mailing Address: Bioclinica Financial Lifecycle Solutions 4505 Emperor Boulevard Suite 130 Durham, NC 27703
TRI and PIs: Support, expectations and collaborations TRI PIs Responsive Engaged - Communication - Responsiveness to TRI operational team and CROs through Website especially now on follow up - Provide constant - Representatives of GARFIELD VTE Collaboration & promote nationally support/resources -be part of a large network of - Regular Contact expert investigators in the field Motivational Active - Access to the data for publication - Newsletters and presentations - Progress update Inspirational Pro-active - Contribute to Garfield-VTE data by completing follow up data - Point of contact - Visit the website for the latest update, presentations and data
Global Operational Priorities Workshop Led by Dr Clifford Smith, Gloria Kayani and Elizabeth Demmisse
Garfield-VTE Workshop Discussion points • Data Query • Follow-up challenges • Physicians Villalta – 36 Months • Communication plan • Site Payments • Data Query resolution timeline • Website : http://vte.garfieldregistry.org/
Follow- Up Challenges • Patient Retention • Lost to Follow up patients • Is completing Patient questionnaires an issue? • When do you declare patient is LTF? • What is the plan to complete 24- 36 Months Physician Villalta? • Challenges/Issues seeing patients during 24Montha to 36 months follow up period? • What if the patient is not planned to be seen during this time? • Can we invite the patient for visit? • Challenges completing Patients Reported Questionnaires • Any National Challenges?
10 15 20 25 0 5 South Africa - Patients Reasons for Withdrawal Patient no longer meets ZAF0078 1 inclusion/exclusion criteria Patient died 17 ZAF0079 Patient lost to follow-up 10 Patient no longer meets 1 inclusion/exclusion criteria Patient died 1 ZAF0080 Patient lost to follow-up 3 Patient withdrew consent 1 Patient died 8 ZAF0102 Patient lost to follow-up 16 Patient withdrew consent 1 Patient died 22 ZAF0121 Patient lost to follow-up 6 Patient died 1 Patient no longer meets ZAF0323 1 inclusion/exclusion criteria Patient withdrew consent 1 Patient died 1 ZAF0357 Patient lost to follow-up 4 Patient withdrew consent 4 ZAF0404 Patient died 1
Central venous catheter related thrombosis- South Africa vs Global 12000 YES, 98 10000 8000 NO, 10075 6000 4000 YES, 2 2000 NO, 413 0 Global South Africa
Missing Anticoagulants Data- South Africa vs Global 379 Incomplete Data 8555 Complete Data 30 1345 GLOBAL SOUTH AFRICA
South Africa- Anticoagulants Data Missing per Site 8 6 5 4 2 2 2 1 ZAF0322 ZAF0065 ZAF0102 ZAF0355 ZAF0080 ZAF0121 ZAF0323 ZAF0067
Characterisation of Distal and Proximal DVT- South Africa vs Global Sou South Afric frica Glob lobal 278 0 Distal/Proximal data Distal/Proximal data complete complete Distal/Proximal data Distal/Proximal data missing missing 7515 304
South Africa- Patient Questionnaires Status Villalta SF12 350 450 0 0 0 0 31 25 59 400 300 45 113 Withdrawn 87 147 350 108 Withdrawn 250 154 113 Not reached 145 300 Not reached 108 200 250 48 150 Not filled Not filled Incomplete Incomplete 118 137 150 200 70 118 Not done Not done 92 67 150 Filled 100 80 Filled 153 55 100 132 101 120 89 113 44 50 28 50 29 21 0 0 Baseline 3 Months 6 Month 24 Month Baseline 3 Months 6 Month 24 Month
Physicians Villalta – 36 Months
Communication Plan TRI communicates directly with NCIs (emails and calls) Website NCIs also communicate Community Portal directly with PIs (sites) to as a platform for keep them engaged and FAQs, Q&A on a motivated to achieve key regional and global registry milestones level. GARFIELD VTE • Newsletters Reports Website On a monthly (Global • Regular Community Portal basis Newsletter) Updates Login
Data Query Resolution Timeline and Task Data reviewed and Query Manually raised Timeline for Completion Events December 31 st 2017 PRO To resolve all data queries in the Recurrent VTE Clinpal system Early withdrawal form Extra Information Any Challenges getting queries resolved by end of December 2017? Tips and suggestions from the team on how they plan to achieve
Investigators, Sub- Investigators and Study Coordinators Thank You! Dr Rapule Ratse la Dr Shaun Maasdorp Dr Modise Koto Dr Muhammad Hameed Dr Mohamed Khan Dr Mohamed Abdool-Gaffar Dr Clifford Smith Prof Barry Jacobson Dr Abraham Bezuidenhout Dr Nishen Paruk Dr Louis Botha Dr Grace Kaye-Eddie Dr David Adler Dr Dirk Le Roux
Discussion
Closing remarks Rt Hon. Professor the Lord Kakkar PC
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