Planning and management of a clinical trial abroad
Click here to load reader
-
Upload
zeta-research -
Category
Health & Medicine
-
view
50 -
download
2
description
Transcript of Planning and management of a clinical trial abroad
![Page 1: Planning and management of a clinical trial abroad](https://reader038.fdocuments.us/reader038/viewer/2022100600/555cbe82d8b42a64718b4bc2/html5/thumbnails/1.jpg)
CRO4Q Contract Research Organization
Best practice
Copyright © 2013 Zeta Research S.r.l.
![Page 2: Planning and management of a clinical trial abroad](https://reader038.fdocuments.us/reader038/viewer/2022100600/555cbe82d8b42a64718b4bc2/html5/thumbnails/2.jpg)
Case 4:
Planning and management of a clinical trial abroad
• A post-market Medical Device clinical trial in an extra-EU country
2 Copyright © 2013 Zeta Research S.r.l.
![Page 3: Planning and management of a clinical trial abroad](https://reader038.fdocuments.us/reader038/viewer/2022100600/555cbe82d8b42a64718b4bc2/html5/thumbnails/3.jpg)
Client:
An Italian manufacturer of Medical Devices standing on the international
market.
Client’s aims:
Design and conduct of a clinical study post-market as quickly as possible.
Specific advanced requirements:
Randomized clinical trial
Clinical data to be spent directly for marketing purposes
Urgency to receive analyzed data (6-7 months)
Marketability, traceability and maximum transparency of collected data
Absolute compliance with Good Clinical Practice
Case 4
Copyright © 2013 Zeta Research S.r.l. 3
![Page 4: Planning and management of a clinical trial abroad](https://reader038.fdocuments.us/reader038/viewer/2022100600/555cbe82d8b42a64718b4bc2/html5/thumbnails/4.jpg)
Proposed solution:
• Scientific conception and study design of the research project from the
scientific literature and the data of the producer-client
• Drafting the study protocol, CRF and additional documents for the Ethics
Committee
• Recruitment of an investigational center in an extra EU country to maximize
resources and time
• Documentation translation and adaptation to local requirements
• Study conducting according to GCP
• Data analysis and clinical-statistical reporting
Case 4
Copyright © 2013 Zeta Research S.r.l. 4
![Page 5: Planning and management of a clinical trial abroad](https://reader038.fdocuments.us/reader038/viewer/2022100600/555cbe82d8b42a64718b4bc2/html5/thumbnails/5.jpg)
Methods and tools:
• Strong and consolidated partnership in the country
• Adaptation and certified translation into the local language of all the
documentation of the study in accordance with local requirements
• Site recruitement and site training
• Site monitoring
• IEC approval
• Logistical management of experimental products
• Conduct in accordance with GCP
• Remote data management
• Data analysis performed by the internal biostatistician team
• Planning and development of a Clinical and Statistical final report.
Case 4
Copyright © 2013 Zeta Research S.r.l. 5
![Page 6: Planning and management of a clinical trial abroad](https://reader038.fdocuments.us/reader038/viewer/2022100600/555cbe82d8b42a64718b4bc2/html5/thumbnails/6.jpg)
Advantages of conducting a post-market MD clinical trial abroad:
• Clear and essential rules for clinical trials with medical devices
• Direct and clear relationship with regulatory authorities and ethics
committees
• Same approach to ethical and scientific evaluation of the study as in EU
• Qualified and helpful investigators
• Modern and “western” clinical structures (with fast internet connection)
• High flow of patients willing to be involved in a clinical trial
Case 4
Copyright © 2013 Zeta Research S.r.l. 6
![Page 7: Planning and management of a clinical trial abroad](https://reader038.fdocuments.us/reader038/viewer/2022100600/555cbe82d8b42a64718b4bc2/html5/thumbnails/7.jpg)
Case 4
ANALISYS AND REPORTING (3 weeks)
Close-out Data analisys Reporting
RUNNING TRIAL (3 months)
Enrolling and follow up visits
START UP (6 weeks)
Site recruitment and negotiation
IEC approval Logistical management of
experimental products
PLANNING (6-8 weeks)
Scientific planning and documents drafting
Review and translation Data collection system
implemntation
Copyright © 2013 Zeta Research S.r.l. 7
![Page 8: Planning and management of a clinical trial abroad](https://reader038.fdocuments.us/reader038/viewer/2022100600/555cbe82d8b42a64718b4bc2/html5/thumbnails/8.jpg)
Client’s satisfied aims
Case 4
• Optimized timing according to objectives and deadlines
• Scientific and methodological rigor of the collected data, supported by the maximum optimization of resources (30% costs’ reduction)
• Clear and effective reporting in full compliance with the goals set by the client
• Study conducted in accordance with the GCP
Copyright © 2013 Zeta Research S.r.l. 8