National Coordinating Investigators
Newsletter No. 2
Dear National Coordinating Investigators,
Welcome to the second edition of the Garfield VTE Newsletter. As of the first week in June, we have recruited
1074 patients globally.
June, 2015
We are pleased to share with you the preliminary baseline results on patient characteristics, planned
treatment, prior treatment and risk factors for the first 1,000 patients:
Global News
and Announcements
The first publication on the Garfield VTE study is planned for
the first quarter of 2016 and we hope to include as many
patients as we can in the analysis. In order to have meaning-
ful results from each country, we will need to have at least
cohort 1 completed by December 2015. Your help in en-
couraging the sites in your country to achieve this will be
much appreciated.
Some countries have already started to organise local
meetings by teleconference to identify barriers to enrol-
ment. We will be contacting you shortly to discuss the feasi-
bility and logistics of these local meetings in your country. In
addition, as summer is approaching in most countries, many
site personnel are planning their summer vacation. Please
remind the sites to ensure that there is sufficient cover at
the sites to ensure that enrolment is not adversely impacted
during these few months.
Project Team at TRI
Gloria Kayani (Chief Operating Officer), Pearl Kho (Global Project Manager), Richard Coles (Regional Project
Manager, Americas, Asia), Elizabeth Demmisse (Regional Project Manager, EMEA), Sofia Fernandez
(Research Coordinator, UK, France, Spain), Luz Angela Gomez (Clinical Trial Administrator).
GARFIELD-VTE Newsletter no. 2 June 2015
www.tri-london.ac.uk
GARFIELD-VTE – Recruitment in Spain
0
100
200
300
400
500
600
Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15 Dec-15
Target Projected Actual
Total recruited =
366
500
183
Target = 300
Clarification of Inclusion and Exclusion Criteria:
(1) Patients who have a short life expectancy, for example, less than 6 months should be excluded (2) Patients who have been treated for previous AF rather than VTE should be excluded
Study Timelines
Global recruitment is currently behind target, all efforts should be made to ensure that at least Cohort 1 is completed by December
Electronic Data Capture System (Clinpal)
On-line tutorial will be available in July to familiarise users with the system Project Team at TRI
Gloria Kayani (Chief Operating Officer), Pearl Kho (Global Project Manager), Richard Coles (Regional Project Manager, Americas, Asia), Elizabeth Demmisse (Regional Project Manager, EMEA), Sofia Fernandez (Research Coordinator, UK, France, Spain), Luz Angela Gomez (Clinical Trial Administrator).
Site Recruitment
GARFIELD-VTE Newsletter no. 2 June 2015
Spain Status
Target number of sites 20
Number of sites Invited 105
Number of Sites Expressed an Interest 29
Number of completed FQs 29
Sites selected 20
R&D/EC submission done 12
R&D/EC approved 3
CTA fully executed 1
SIV completed 1
Recruitment Target 300
First Patient First Visit Estimated June 2015
GARFIELD-VTE Newsletter no. 2 June 2015
Site Name PI Name Estimated
Date of
Submission
Date of
Submission
Meeting
Date
(Projected)
Estimated
Date of
Approval
Date of
Approval
First Site
Contract
Draft Creat-
First Site Con-
tract Final
Sent to Site
Estimated
Date Con-
tract Fully
SIV Date
H. Trias I Pujol Manuel Monre-
al Bosch
1-5 may
2015
01/May/15 11/May/15 29/May/15 17/May/15 N/A 01/May/15 12-Jun/2015 Jun-15
H Santa Creu I
Sant Pau
Juan Carles
Souto
1-5 may
2015
04/May/15 25/May/15 29/May/15 Pending 22/Apr/15 27/Apr/15 12-Jun/2015 Jun-15
H Vall D'Hebron Josep Suriñach
Caralt
1-5 may
2015
01/May/15 25/May/15 29/May/15 Pending N/A 01/May/15 12-Jun/2015 Jun-15
H Ramon y Cajal David Jiménez 1-5 may
2015
04/May/15 25/May/15 29/May/15 Pending 08/05/15 15/05/15 12-Jun/2015 Jun-15
H Provincial
Reina Sofia
Lucian López-
Jiménez
1-5 may
2015
01/May/15 25/May/15 Unknown Pending 15/05/15 TBC 30-Jun-2015 Jul-15
H El Vendrell David Riesco
Acevedo
1-6 June
2015
TBC 25/Jun/15 30/Jun/15 TBC 20/May/15 20/May/15 12-Jul-2015 Jul-15
H. Trueta Ferran García-
Bragado
Dalmau
1-6 June
2015
TBC 25/Jun/15 30/Jun/15 TBC Pending Pending 12-Jul-2015 Jul-15
H. Infanta Mar-
garita
Raimundo
Tirado Miranda
1-6 June
2015
TBC 25/Jun/15 30/Jun/15 TBC Pending Pending 12-Jul-2015 Jul-15
Hospital Univer-
sitario de Gran
Canaria Dr.
Negrín
Oscar, Sanz 1-6 June
2015
TBC 25/Jun/15 30/Jun/15 TBC Sent for
translation
22/05/15
Pending 12-Jul-2015 Jul-15
H. Universitario
Madrid Norte
Sanchinarro
Bárbara Pagán 1-6 June
2015
TBC 25/Jun/15 30/Jun/15 TBC Pending Pending 12-Jul-2015 Jul-15
H Virgen Mac-
arena
Juan Carlos
Álvarez Benítez
1-6 June
2015
TBC 25/Jun/15 30/Jun/15 TBC Pending Pending 12-Jul-2015 Jul-15
Hospital Parc
Sanitari Sant
Joan de Deu
Pablo Javier
Marchena
1-6 June
2015 (for
secondary
CEIC)
TBC 25/Jun/15 30/Jun/15 05/05/15
pending
Secondary
CEIC aprov-
Pending Pending 30-Jun-2015 Jul-15
Hospital Vega
Baja
M. Lorente 1-6 July
2015
TBC TBC TBC TBC TBC TBC 12-Jul-2015 Sep-15
Hospital Clínico
Universitario de
Santiago
J. Díaz 1-6 July
2015
TBC TBC TBC TBC TBC TBC 12-Sep-2015 Sep-15
Hospital General
Univ. Gregorio
Marañón
Jorge del Toro 1-6 July
2015
TBC TBC TBC TBC TBC TBC 12-Sep-2015 Sep-15
Hospital Reina
Sofía de Tudela
Angel Sampériz
legarre
1-6 July
2015
TBC TBC TBC TBC TBC TBC 12-Sep-2015 Sep-15
Hospital Virgen
del Rocío
Remedios
Otero
1-6 July
2015
TBC TBC TBC TBC TBC TBC 12-Sep-2015 Sep-15
Hospital Univer-
sitario de Bell-
vitge- Idibell
Antoni Riera-
Mestre
1-6 August
2015
TBC TBC TBC TBC TBC TBC 12-Oct-2015 Sep-15
Hospital Sier-
rallana
Reina Valle 1-6 August
2015
TBC TBC TBC TBC TBC TBC 12-Oct-2015 Oct-15
Hospital Univer-
sitario La Fe
Raquel López-
Reyes
1-6 August
2015
TBC TBC TBC TBC TBC TBC 12-Oct-2015 Oct-15
Hospital General
Univ. de Alicante
Luis Manuel
Hernández
Blasco
1-6 August
2015
TBC TBC TBC TBC TBC TBC 12-Oct-2015 Oct-15
Hospital Sant
Joan Despí-
Moisés Broggi
Esther Usandi-
zaga
1-6 August
2015
TBC TBC TBC TBC TBC TBC 12-Oct-2015 Oct-15