Download - The European MDS studies coordination office
The European MDS studies coordination office
Supporting Clinical Research, Education and Consulting in the field of MDS across Europe
EMSCO
Current MDS Clinical Trial Landscape in Europe
Multiple (69) MDS clinical trials are currently running across the EUOf 395 worldwide open trials with known status, 18 are in Germany, 26 in France, 19 are in Italy
The French Groupe Francophone des Myélodenysplasies (GFM) and the German MDS study group (GMDS-SG) sponsor 14 clinical trials in MDS
GMIHO (Dresden, Germany) is a specialist “Principal Investigator Network”, which pools scientific expertise to offer an efficient infrastructure for clinical trials. Sponsors 3 clinical trials in MDS
Concept for Cooperation
National Study Groups partner with the ELN-based EMSCO officeto carry out international MDS clinical trials
Groupe Francophone des Myélodenysplasies (GFM - France)
German MDS study groupGMDS-SG
Common MDS
Clinical Trials
Other
National MDS
Groups
The Industry has MDS candidate drugs in development in Phase II and will need to launch Phase III trials in the next 5 years.
*Market data from Global data 2012
1. International trials are required to enroll enough patients
2. EC statistics 2007 – 2009 showed a 10% drop in clinical trials in the EU and a 33% drop in the number of EU patients entering clinical trials
3. MDS classification has become more complex and changes in clinical trial structure must reflect that there are smaller subgroups which require more sites
Trends in MDS
The Industry has MDS candidate drugs in development in Phase II and will need to launch Phase III trials in the next 5 years.
*Market data from Global data 2012
Over the next 5-7 years new medications in MDS will come into clinical testing, international clinical trials will be necessary
International cooperation may be particularly important in the following cases:
- high risk MDS first line, to determine the best drugs to combine with HMA
- high risk second line, after HMA failure
- low risk non del 5q second line (after EPO failure)
- low risk del 5q second line (after LEN failure, or in case of TP 53 mutation)
Trends in MDS
Phase 2 (2013):
1. Sustainable and financially independent EMSCO –external funding
2. Website, logo 3. Common trials (GFM/GMDS-SG) are in planning
with the goal to identify hurdles and practical problems (e.g. submission to IRB and national authorities, insurance, central randomization, monitoring etc.)
www.emsco.eu
EMSCO: MDS Studies Coordination Office Phase 1:
Within the ELN, an Office has been set-up located in Dresden and administered by the GMIHO in Berlin
• European Platform for MDS trials
• Single-point of contact - efficient andcoordinated European trials in MDS
• Standardization of SOPs and treatmentparadigms – reduces regulatoryuncertainty regarding international trials
• Improvement in best practices andcomparability of trial results acrossnational borders
Consulting
Academic Clinical Research
Education
Phase 3 (2013/2014/2015)
Three Pillars of EMSCO
• Standardized Clinical Trial Documents - improving the quality andcomparability of clinical trials, eCRF
• SOPs for MDS trials
• Advantages: established by academia, research oriented, nooverhead costs, offers management services, impartial documentevaluation
ServicesSponsor FunctionSite recruiting / feasibilityEssential trial documents (protocol, regulatory submission)Medical WritingNative English proof-readingMDS specific eCFRs and SOPsMonitoring & BiostatisticsData ManagementCoordinator function for EU grants
Academic Clinical Research
• Conferences - organization of MDS specific conferences, symposium organization and strategy-development meetings
• Publications - coordination and conceptualization of common scientific, reviews, white papers and grants in the field of MDS
• Industry Career Development – Training sessions, video content
ServicesConference planningEducational seminars in MDSEducational symposia in MDSGCP training and refresher coursesWriting the Scientific Paper in EnglishTraining in MDS Diagnostics
Education
MDS Colloquium –
Berlin March 2014!
• Commentary on clinical trial design, research projects, grant programs, demographics and epidemiology
• Advice to the pharmaceutical industry and to regulatory agencies on MDS best practices
• Expert opinion on all MDS related questions
ServicesTreatment paradigms in MDSClinical Trial Design for MDSWhite Papers in MDSRegulatory Consultancy Feasibility StudiesGrant ReviewIntellectual property reviewAssessment of trial design for novel compounds
Consulting
1. Inter-european clinical trials in MDS (AVATAR, EUROPE, CMML DAC-HY)
2. European site mapping – key/prime sites for MDS clinical trials
3. Organization of Kick-off meeting – Paris Sept 18, 2013
4. Organization of MDS Colloquium Mar. 2014
5. Organization of 3rd French-German MDS meeting Berlin, Sep. 2014
6. Creation of „open source“ clinical trial documents (i.e. contract templates, eCRF)
7. Establish competency center for MDS
8. Invite sites and Investigators to participate in EMSCO and become listed on the website
Ongoing EMSCO Activities
www.emsco.eu
Websites: Educational material for MDS
Promotions
Newsletter: Reaching 2000
Hematologists in Germany
www.mdsdiagnosis.com
EMSCO - European MDS Studies Coordination Officepowered by GMIHO - Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH Alte Jakobstraße 77, 10179 BerlinTelefon: +49 351-259 33-283 | Telefax: +49 351-259 33-111
Thank you for your attention!
Mission Statement EMSCOThe European MDS studies coordination office
(EMSCO)- Facilitating academic clinical research, education and consulting in the field of MDS across
Europe
EMSCO builds bridges between academic and pharmaceutical clinical developers by:
• Facilitating research• Improving data quality• Accelerating translation and optimizing trial
recruitment in MDS to ultimately improve patient outcomes
The Group (Gesellschaft) for Medical Innovation in Hematology and
Oncology (GMIHO - Dresden, Germany)
Thank you for your attention!