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www.ebmt.org #EBMT16 Information (Leiden and London) & Update MK-8228 CMV trial A Merck (MSD) sponsored trial (73 sites, 20 countries), with EBMT supporting 50 of the sites (17 countries) by providing a recruitment and retention service. Design A phase 3, multi-centre placebo-controlled trial of approximately 540 patients with a 2:1 randomisation. Recruitment started in June 2014 and ended in March 2016 (recruitment was achieved ahead of time). Enrollment EBMT Role • Monitoring recruitment and retention in EBMT supported sites, identifying struggling sites and providing PI led TC support to those sites. • Holding annual workshops for PI’s attending the EBMT Annual Conference. • Arranging PI led group TC’s for PI’s and other site staff. • Having regular TC’s with Merck HQ to discuss any issues and mitigation measures. Participating countries and patients 0 100 200 300 400 500 600 June July Aug Sept Oct Nov Dec Jan Feb Mar Apr May June July Aug Sept Oct Nov Dec Jan Feb Mar Number of Subjects Cumulative Enrollment MK-8228 PN001 Status Report Planned (Base) The EBMT has a Clinical Trials Office (CTO), which is based in London and Leiden. The CTO offers the following services for EBMT sponsored trials: • Protocol design and feasibility • Competent Authority and Ethics Committee submissions • IMP management • Pharmacovigilance, including IDMC • Recruitment and retention services • Monitoring and centre/vendor oversight • Contract negotiation and budget management • Quality management and auditing • Data management and statistics • Report writing The CTO runs the following types of prospective clinical trials: • Phase II-IV, including post-authorisation safety studies • Investigator initiated trials Since 2011, all trials sponsored by the EBMT have been reviewed and selected for sponsorship by the EBMT CT2 committee, which is chaired by Charlie Craddock. The committee includes at least 4 physicians who review the scientific content and EBMT staff who review the statistics, finance/legal and operations of each proposal. For further details, see the Guidance For Investigators on the EBMT website /Committees. Science Statistics Finance/Legal Operations Board WP Chair ASTIMS Mancardi GL, et al. Neurology, 2015 Mar 10; 84(10):981-988. Autologous Hematopoietic Stem Cell Transplantation in Multiple Sclerosis: A Phase II Trial. ASTIC Hawkey CJ, et al. JAMA, 2015; 314(23):2524-2534. Autologous Haemopoietic Stem Cell Transplantation for Refractory Crohn Disease: A Randomised Clinical Trial. CTOM: Liz Clark London [email protected] Acting CTOM (-May 2016): Alain Barrois Leiden [email protected] Clinical Trials Coordinators: Annelies Kleijne Leiden [email protected] Eline Smits Leiden [email protected] Janette Zarev London [email protected] Marleen van Os Leiden marleen.van_os_franse[email protected] Ruzena Uddin London [email protected] Sue Philpott London [email protected] Clinical Trials at the EBMT How to start a trial at the EBMT – the CT2 committee Publications in 2015 The CTO team Sponsor SOPs / Working practices Directives National Legislation Regulations Protocol Contracts Guidelines Data Management Publication Analysis Budget Important issues • Week 24 visit is a vital endpoint and must be completed. Sites should use the treatment calendar to determine the date. Sites will also receive a reminder about the patients concerned. Data should be entered into EDC within 5 days. • Record prescription of Campath or ATG in the eCRF under prior meds or concomitant meds. • Inform Merck / MSD as soon as CMV disease is suspected. The essential documents can then be collected and assessed. CMV does not need to be confirmed prior to notification. • Sites must ensure that the protocol is followed and data is completed in time. This will lower the number of protocol deviations. EBMT Contacts Sue Philpott (Clinical Trials Coordinator) Alain Barrois (Acting Clinical Trials Operations Manager) EBMT Clinical Trials Office Trial to Evaluate Safety and Efficacy of MK-8228 (Letermovir) for the Prevention of Human Cytomegalovirus (CMV) Viremia and/or Disease in Adult CMV Seropositive Allogeneic HSCT subjects MK-8228 CMV Trial Region Country Number of sites opened per country Total patients randomised to March 2016 Europe Austria 2 28 Belgium 2 32 Finland 1 14 France 3 21 Germany 4 34 Italy 4 32 Lithuania 1 5 Poland 2 12 Romania 2 7 Spain 5 32 Sweden 2 20 UK 3 12 EEMEA Turkey 6 36 Asia/Pacific New Zealand 2 9 Japan 5 36 South Korea 5 9 North America Canada 1 19 US 21 203 Latin America Brazil 1 1 Peru 1 8 Total (EBMT supported) 17 countries 50 358 Total (non-EBMT supported) 3 countries 23 212 Total (all) 20 Countries 73 570
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DESIGN GUIDE
This PowerPoint template produces a standard A0
format (84,1cm x 118,9cm) research poster. You can
use it to create your poster that will be displayed on
the EBMT stand. This template will save valuable time
placing titles, subtitles, text, and graphics, and it will
allow homogeneity throughout the various posters.
QUICK START
Select desired layout When designing your own poster, you will be able to choose
between the two proposed layouts - the single or the double
column - according to the information you will have to
present.
Simply click right on the slide>layout: office theme, single
column or double column
Title, Authors, and Affiliations Start designing your poster by adding the title and subtitle,
the names of the authors, and the affiliated institutions. This
titles are indicative and you can change the type of
information.
Adding Sponsor logos Do not remove or move the EBMT logo. You can insert a logo
(of a sponsor for instance) where the red frame is. Logos
taken from web sites are likely to be low quality when
printed. Zoom it at 100% to see what the logo will look like
on the final poster and make any necessary adjustments.
Photographs / Graphics You can add images by dragging and dropping from your
desktop, copy and paste, or by going to INSERT > PICTURES.
Resize images proportionally by holding down the SHIFT key
and dragging one of the corner handles. For a professional-
looking poster, do not distort your images by enlarging them
disproportionally.
The image and/or graphic captions should be written in Arial
20 and centered.
Image Quality Check Zoom in and look at your images at 100% magnification. If
they look good they will print well.
QUICK START (cont. )
Text size Adjust the size of your text based on how much content you
have to present.
The default template text offers a good starting point.
Graphs / Charts You can simply copy and paste charts and graphs from Excel
or Word. Some reformatting may be required depending on
how the original document has been created.
How to remove the info bars You can delete the info bars by going to VIEW > SLIDE
MASTER.
Save your work Save your poster as a PowerPoint document (.ppt/.pptx) and
send it to the EBMT Communication Coordinator:
THANK YOU!
Information (Leiden and London) &
Update MK-8228 CMV trial
A Merck (MSD) sponsored trial (73 sites, 20 countries), with EBMT supporting 50 of
the sites (17 countries) by providing a recruitment and retention service.
Design A phase 3, multi-centre placebo-controlled trial of approximately 540
patients with a 2:1 randomisation. Recruitment started in June 2014 and ended
in March 2016 (recruitment was achieved ahead of time).
Enrollment
EBMT Role
• Monitoring recruitment and retention in EBMT supported sites, identifying
struggling sites and providing PI led TC support to those sites.
• Holding annual workshops for PI’s attending the EBMT Annual Conference.
• Arranging PI led group TC’s for PI’s and other site staff.
• Having regular TC’s with Merck HQ to discuss any issues and mitigation measures.
Participating countries and patients
0
100
200
300
400
500
600
Jun
e
July
Au
g
Sep
t
Oct
No
v
Dec Jan
Feb
Mar
Ap
r
May
Jun
e
July
Au
g
Sep
t
Oct
No
v
Dec Jan
Feb
Mar
Nu
mb
er
of
Sub
ject
s
Cumulative Enrollment
MK-8228 PN001 Status Report
Planned(Base)
The EBMT has a Clinical Trials Office (CTO), which is based in London and
Leiden. The CTO offers the following services for EBMT sponsored trials:
• Protocol design and feasibility
• Competent Authority and Ethics Committee submissions
• IMP management
• Pharmacovigilance, including IDMC
• Recruitment and retention services
• Monitoring and centre/vendor oversight
• Contract negotiation and budget management
• Quality management and auditing
• Data management and statistics
• Report writing
The CTO runs the following types of prospective clinical trials:
• Phase II-IV, including post-authorisation safety studies
• Investigator initiated trials
Since 2011, all trials sponsored by the EBMT have been reviewed and selected
for sponsorship by the EBMT CT2 committee, which is chaired by Charlie
Craddock.
The committee includes at least
4 physicians who review the
scientific content and EBMT
staff who review the statistics,
finance/legal and operations of
each proposal. For further details, see
the Guidance For Investigators on the EBMT website /Committees.
Science Statistics
Finance/Legal Operations
Board WP
Chair
ASTIMS Mancardi GL, et al. Neurology, 2015 Mar 10; 84(10):981-988.
Autologous Hematopoietic Stem Cell Transplantation in Multiple
Sclerosis: A Phase II Trial.
ASTIC Hawkey CJ, et al. JAMA, 2015; 314(23):2524-2534. Autologous
Haemopoietic Stem Cell Transplantation for Refractory Crohn Disease:
A Randomised Clinical Trial.
CTOM: Liz Clark London [email protected]
Acting CTOM (-May 2016): Alain Barrois Leiden [email protected]
Clinical Trials Coordinators: Annelies Kleijne Leiden [email protected]
Eline Smits Leiden [email protected]
Janette Zarev London [email protected]
Marleen van Os Leiden [email protected]
Ruzena Uddin London [email protected]
Sue Philpott London [email protected]
Clinical Trials at the EBMT
How to start a trial at the EBMT – the CT2 committee
Publications in 2015
The CTO team
Sponsor SOPs /
Working practices
Directives
National
Legislation
Regulations
Protocol
Contracts
Guidelines
Data Management
Publication
Analysis
Budget
Important issues
• Week 24 visit is a vital endpoint and must be completed. Sites should use the
treatment calendar to determine the date. Sites will also receive a reminder
about the patients concerned. Data should be entered into EDC within 5 days.
• Record prescription of Campath or ATG in the eCRF under prior meds or
concomitant meds.
• Inform Merck / MSD as soon as CMV disease is suspected. The essential
documents can then be collected and assessed. CMV does not need to be
confirmed prior to notification.
• Sites must ensure that the protocol is followed and data is completed in time.
This will lower the number of protocol deviations.
EBMT Contacts Sue Philpott (Clinical Trials Coordinator)
Alain Barrois (Acting Clinical Trials Operations Manager)
EBMT Clinical Trials Office
Trial to Evaluate Safety and Efficacy of MK-8228 (Letermovir) for
the Prevention of Human Cytomegalovirus (CMV) Viremia and/or
Disease in Adult CMV Seropositive Allogeneic HSCT subjects
MK-8228 CMV Trial
Region Country Number of sites
opened per country
Total patients randomised
to March 2016
Europe
Austria 2 28
Belgium 2 32
Finland 1 14
France 3 21
Germany 4 34
Italy 4 32
Lithuania 1 5
Poland 2 12
Romania 2 7
Spain 5 32
Sweden 2 20
UK 3 12
EEMEA Turkey 6 36
Asia/Pacific
New Zealand 2 9
Japan 5 36
South Korea 5 9
North America Canada 1 19
US 21 203
Latin America Brazil 1 1
Peru 1 8
Total (EBMT supported) 17 countries 50 358
Total (non-EBMT supported) 3 countries 23 212
Total (all) 20 Countries 73 570
