czech regional meeting - combacte...recruitment strategies saatellite (partly site selec) medimm hu,...
TRANSCRIPT
Czech Regional Meeting
COMBACTE CLIN-Net
10 OCTOBER 2017 MIRANDA HOPMAN
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Develop and maintain a premier clinical
research infrastructure in the field of
infectious diseases
Optimize execution of clinical studies
COMBACTE CLIN-Net objectives
CLIN-NET Network
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CLIN-Net Network in Czech Republic
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CLIN-Net tasks
• Site feasibility, assessment and selection
• Trial management (preparation and execution)
• Training
• Good Clinical Practice (GCP)
• Building of durable international network
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Site selection process
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•CLIN-Net, LAB-Net, the industry sponsor, study lead and invited consultants
•Voting and non-voting members
•SSB and voting procedures
Create site selection plan
•Metadatabase and baseline questions as basis
•Streamline questionnaires so that pre-filling is available
•Create separate clinical and laboratory questionnaires
•Review questionnaires by the study team
Create feasibility questionnaire
•Notify CLIN-Net and LAB-Net of selection criteria
•Ask national coordinator for advise/support
•Pre-select sites from NMS based on specific requirements
Site pre-selection and recruitment
•Send an invitation letter to the investigators
•Send CDA, if applicable
•Follow up sites to obtain signed CDA’s
•Send protocols
Send out invitation letter
•Send out feasibility questionnaire
•Remind sites to complete the questionnaires via NMS/e-mail/phone
Send out questionnaires
•Provide feasibility report
•Follow-up on additional information (national coordinator)
•Vote on whether to include sites
Site selection board meetings
•Inform sites on the voting results via a feasibility conclusion letter
•Inform national coordinators/ networks of the results
Finalize site selection process
Site Selection COMBACTE studies
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Consortium Study Countries (n)
FQ sent (n)
FQ completed
(n%)
Sites selected
(n)
Sites not selected
(n)
Sites cancelled
(n)
COMBACTE-NET
ASPIRE-ICU 11 155 41% (57) 30 20 10
ASPIRE-SSI 21 246 36% (89) 23 47 9
SAATELLITE Site selection by PPD 109 NA 1
ANTICIPATE 9 88 59% (52) 34 7 0
COMBACTE-CARE
EURECA 10 130 64% (83) 53 20 3
REJUVENATE 3 36 83% (30) 21 5 1
ATM-AVI 12 175 74% (130) 93 18 2
COMBACTE-MAGNET
RESCUING 8 43 70% (30) 20 4 3
EVADE 12 260 58% (150) 72 NA 9
Other studies
CTTI 3 38 45% (17) 12 5 NA
OVERCOME 4 36 58% (21) 11 NA NA
CREDIBLE 9 152 73% (111) 51 NA 32
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Study Sponsor Contracting Monitoring eCRF support
Optimizing recruitment
strategies
SAATELLITE (partly site selec)
MedImm HU, CZ X
ASPIRE-ICU UMCU X X X X
ASPIRE-SSI UMCU X X X X
ANTICIPATE UMCU X X X X
EVADE MedImm HU, CZ, SL
RESCUING Bellvitge X X X
REJUVENATE Pfizer
WP2B Pfizer partly partly partly
EURECA Virgen Macarena
X
CLIN-Net Network in Czech Republic
Hospitals participating in Network: 25 hospitals in 18 cities
Investigator contacts in Network: 78 investigators
Hospitals participating in COMBACTE studies: 13 different hospitals
in 5 studies
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5
10
2
6
1
# sites participating in COMBACTE studies
WP2B ATM-AVI SAATELLITE ASPIRE-ICU EVADE ASPIRE-SSI
Sites participating in COMBACTE studies
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Organisation WP2B ATM-AVI SAATELLITE ASPIRE-ICU EVADE ASPIRE-SSI
Charles University Medical School Plzen Selected QV
Faculty Hospital Brno Selected QV
Fakultni nemocnice Olomouc Selected QV Selected
General University Hospital Prague Selected
Hospital Kyjov Selected Selected Selected
Krajska zdravotni Decin Selected QV Selected Selected
Krajska zdravotni Nemocnice Teplice Selected Selected
Regional Hospital Kolin Closed Back-up Selected
University Hospital Hradec Kralove Closed
University Hospital Kralovske Vinohrady Closed
University Hospital Motol Selected QV Selected Selected Selected
University Hospital of Ostrava Selected
University Hospital St. Anna Selected Selected
Total 5 10 2 6 1
6 performance indicators as starting point:
• Enrollment rates: actual / predicted number of patients
• Turnaround time for EC/IRB approval
• Turnaround time for contract agreement
• Completion time for eCRFs
• Response time to eCRF queries
• Certified GCP Training Status
COMBACTE classification/certification system
(preliminary)
NMS Reason not selected
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Study overview
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Selected
Not selected
Backup
Study Dashboard
Business Intelligence (BI) Tool
• Uses data from the NMS, RO, or any other database
• Power BI
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CLIN-Net PMO
CLIN-Net infrastructure
CLIN-Net PMO
Regional team
CLIN-Net infrastructure
CLIN-Net PMO
Regional team
CLIN-Net infrastructure
CLIN-Net PMO
Coordinator 1 subnetwork / specialty
LAB-Net PMO
Coordinator 2 subnetwork / specialty
Coordinator 3 subnetwork / specialty
Regional team Main contact person LAB-Net coordinator
CLIN-Net infrastructure
National Coordinators
• Responsibilities/Role National Coordinator
• Ambassador for COMBACTE
• Assist in identification and recruitment of local sites for COMBACTE studies
• Advise on local recruitment strategies and local trial execution problems
• Support in local F2F and online GCP training
• Annual CLIN-Net National Coordinator meeting
• 4th National Coordinator Meeting September 28th
• Regular country visits to consolidate the local network and role of
the National Coordinator
• 2016: Greece, Bulgaria, Italy, Portugal and Hungary
• 2017: Romania, Czech Republic, Poland, Croatia, Serbia, Slovakia
National Coordinator Meeting 2017
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Country visits 2016-2017
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Country Date
Greece 13, 14 April 2016
Bulgaria 13, 14 September 2016
Italy 4, 5 October 2016
Portugal 25, 26 October 2016
Hungary 7, 8, 9 December 2016
Romania 11, 12 January 2017
Croatia 11, 12 April 2017
Serbia 9, 10 May 2017
Czech Republic 10, 11 October 2017
Slovakia 13, 14 November 2017
Country Visit Czech Republic
• To further consolidate the clinical and laboratory networks
Building long lasting relationships
Ensure continued success conducting current and future clinical studies in
the area of Infectious Diseases and Intensive Care
• Experience in clinical trials; 250 – 300 clinical trial registrations per year
85-90% are multinational, multicenter studies
Motivated investigators
Regulatory bodies are in general supportive of studies
Access to qualified local staff
High data quality
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Country Visit Czech Republic
• Access to patient population
Centralized healthcare systems concentrate large numbers of patients in
a few, easy to reach locations
Untreated patient population available and willing to participate in clinical
trials
Adherence to treatments and protocols are well accepted (low drop-out
rates)
• Cost-effective
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COMBACTE GCP training
• COMBACTE will (in the near future) require all personnel actively involved in studies to be GCP compliant
• Basically: all people obtaining informed consent and completing research files (CRFs)
• COMBACTE will comply with:
• PharmaTrain (EU accreditation)
• TransCelerate (Pharma requirements)
• EU directives and regulations
• Adequate execution of trials is essential in maintaining our network of investigators that can perform high quality clinical trials
• COMBACTE online GCP Course
• F2F GCP Course
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Online GCP Course
Partnership with Elevate Health, a company specialized in online
education, to develop an interesting, online GCP Course
• Interactive, e-moderator
• Takes 6 to 8 hours to complete, must finish within one calendar
month
• Compliant with TransCelerate requirements
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OPTIONAL TEXT
Investigators trained by CLIN-Net
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Year Face-to-face
GCP courses
Online
GCP course
Czech
Republic
2017 90 73 0
2016 72 111 1
2015 65 81 3
2014 22 19 0
Total 249 284 4
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F2F GCP Training
Podgorica - Montenegro June 2017
Sofia - Bulgaria March 2017
Bucharest - Romania September 2017
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COMBACTE GCP F2F Training
Serbia (Dec. 2015)
• 26 participants
• 1-day program
• In collaboration with EF-GCP
• EURECA investigator Training
Hungary (April 2016)
• 28 participants
• 2-day program
• In collaboration with the national
training institute
Greece (Sept. 2016)
• 47 participants
• 2-day program
Bulgaria (March 2017)
• 28 participants
• 1-day program
• In collaboration with EFGCP and
LAB-Net
Montenegro (June 2017)
• 50 participants (Albania,
Montenegro, Kosovo, Macedonia
• In collaboration with EFGCP and
LAB-Net
Romania, Bucharest (Sept. 2017)
• 30 participants
• 2-day program
• In collaboration with EFGCP and
LAB-Net
Swiss (Jan. 2014)
• 22 participants
• 2-day program
Spain (Nov. 2015)
• 29 participants
• 2-day program
• In collaboration with EF-GCP
In conclusion:
• > 800 sites in 42 countries
• NMS, BI tool, quality system, study dashboards, GCP-
trainings
• Online Training, 9 F2F trainings
• Contributing in 14 initiated studies, 3 studies in
preparation
• 261 hospitals selected for studies
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Thank you for your
Support!