GARFIELD-VTE South Africa I nvestigators Meeting Johannesburg, 28 th - - PowerPoint PPT Presentation

GARFIELD-VTE South Africa

Investigators’ Meeting

Johannesburg, 28th October 2017

Operational Priorities and South Africa Status Update

Elizabeth Demmisse Regional Project Manager Thrombosis Research Institute

Operational Priorities

• 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 Status Update

South Africa Enrolment Status

National Coordinator Investigator: Prof Barry Jacobson Dr Clifford Smith National Care Setting:

 Smaller private hospitals/ rehabilitation clinics 14%  Other (private angiology practices) 53%  Large Hospitals / Academic facilities 33%  18 sites initiated and 14 active sites  416 patients recruited

86 82 70 40 30 30 26 12 10 10 10 4 4 2

10 20 30 40 50 60 70 80 90 100

ZAF0079 ZAF0121 ZAF0102 ZAF0067 ZAF0061 ZAF0357 ZAF0063 ZAF0078 ZAF0065 ZAF0080 ZAF0322 ZAF0323 ZAF0355 ZAF0404

Total=416

South Africa - Patient Milestone

416 401 397 364 175 15 19 52 241

416 416 416 416 213

203

50 100 150 200 250 300 350 400 450

Baseline 3M 6M 12M 24M

Complete Incomplete Due Not due

South Africa-Query status

83 13 12 11 10 9 8 4 4 3 1

10 20 30 40 50 60 70 80 90

ZAF0121 ZAF0102 ZAF0065 ZAF0323 ZAF0079 ZAF0322 ZAF0357 ZAF0061 ZAF0355 ZAF0080 ZAF0078

Total=158

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

Place the mouse pointer over and click to lock the record

To unlock Place the mouse pointer over and click

Click Unlock again

Recent System Update

Recent System Update

Recent System Update

South Africa Patient and Site Retention Status

How many sites initiated and activated? =18 How many sites dropped before recruitment= 4 How many patients recruited? =416 How many withdrawn?=114 Withdrawal rate= 27.4% LTF= 11%

114 58 46 3 7

20 40 60 80 100 120

Total no. patiens withdrawn death LTF Patients NLM Withdraw Consent

South Africa Patient Withdrawn Status

Phase II - On-site Monitoring

Onsite Monitoring will start end

• f October

Phase II planning starts Patient/site selection using risk based score and random selection Training CRA Sites will be informed

Phase I Audit Report will be available

Phase Start Date Cohort Countries *No. of Sites

• No. of cases

per site Variables SDV’d Total Cases to be SDV’d

1 Sep- 16 C1,C2 All, except **Brazil, Mexico, UAE 42 (~10%) 6-10 100% SDV on first patient data following by partial SDV (Critical Variable) 400 (40%) 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

• r 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

Engaged Responsive

Active Collaboration Pro-active Inspirational Motivational

• Communication

through Website

• Provide constant

support/resources

• Regular Contact
• Newsletters
• Progress update
• Point of contact

TRI

• Responsiveness to TRI
• perational team and CROs

especially now on follow up

• Representatives of GARFIELD VTE

& promote nationally

• be part of a large network of

expert investigators in the field

• Access to the data for publication

and presentations

• Contribute to Garfield-VTE data

by completing follow up data

• Visit the website for the latest

update, presentations and data

PIs

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?

South Africa - Patients Reasons for Withdrawal

1 17 10 1 1 3 1 8 16 1 22 6 1 1 1 1 4 4 1

5 10 15 20 25

Patient no longer meets inclusion/exclusion criteria Patient died Patient lost to follow-up Patient no longer meets inclusion/exclusion criteria Patient died Patient lost to follow-up Patient withdrew consent Patient died Patient lost to follow-up Patient withdrew consent Patient died Patient lost to follow-up Patient died Patient no longer meets inclusion/exclusion criteria Patient withdrew consent Patient died Patient lost to follow-up Patient withdrew consent Patient died ZAF0078 ZAF0079 ZAF0080 ZAF0102 ZAF0121 ZAF0323 ZAF0357 ZAF0404

Central venous catheter related thrombosis- South Africa vs Global

NO, 10075 NO, 413 YES, 98 YES, 2

2000 4000 6000 8000 10000 12000

Global South Africa

Missing Anticoagulants Data- South Africa vs Global

8555 1345

379 30

GLOBAL SOUTH AFRICA

Incomplete Data Complete Data

South Africa- Anticoagulants Data Missing per Site

ZAF0322 ZAF0065 ZAF0102 ZAF0355 ZAF0080 ZAF0121 ZAF0323 ZAF0067

8 6 5 4 2 2 2 1

Characterisation of Distal and Proximal DVT- South Africa vs Global

7515 278

Glob lobal

Distal/Proximal data complete Distal/Proximal data missing

304

Sou South Afric frica

Distal/Proximal data complete Distal/Proximal data missing

South Africa- Patient Questionnaires Status

50 100 150 200 250 300 350

Baseline 3 Months 6 Month 24 Month 153 101 89 21 48 70 67 28 108 113 108 55 118 25 45 87

Villalta

Withdrawn Not reached Not filled Not done Filled

Incomplete

50 100 150 200 250 300 350 400 450 Baseline 3 Months 6 Month 24 Month 132 113 120 29 137 118 92 44 147 154 145 80 150 31 59 113

SF12

Withdrawn Not reached Not filled Not done Filled

Incomplete

Physicians Villalta – 36 Months

Communication Plan

TRI communicates directly with NCIs (emails and calls) NCIs also communicate directly with PIs (sites) to keep them engaged and motivated to achieve key registry milestones GARFIELD VTE Website Community Portal Login Newsletters (Global Newsletter) Website Community Portal as a platform for FAQs, Q&A on a regional and global level. On a monthly basis

• Reports
• Regular

Updates

Data Query Resolution Timeline and Task

Data reviewed and Query Manually raised Events PRO Recurrent VTE Early withdrawal form Extra Information

Timeline for Completion

December 31st 2017 To resolve all data queries in the Clinpal system

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 Muhammad Hameed Dr Louis Botha Dr Shaun Maasdorp Dr Mohamed Abdool-Gaffar Dr Abraham Bezuidenhout Dr Grace Kaye-Eddie Dr Rapule Ratsela Dr Dirk Le Roux Dr Mohamed Khan Dr Clifford Smith Dr David Adler Dr Modise Koto Dr Nishen Paruk Prof Barry Jacobson

Discussion

Closing remarks

Rt Hon. Professor the Lord Kakkar PC