Transcript The Fundamentals of International Clinical Research

ICSSC
International Clinical
Sciences Support Center
Family Health International
1
What is the ICSSC?
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DMID contract for investigators funded by
NIH/NIAID/DMID conducting research at
resource-constrained foreign sites
Located at Family Health International (FHI),
a diverse public health research organization
working mainly in the developing world.
Composed of an interdisciplinary team of
experts in various areas of clinical research.
Who is the ICSSC?
Clinical
Trials/
Protocol
Specialists
Logistics/
Event Planners
Data Managers
Who is
the ICSSC?
Study
Design/
Methodology
Experts
Biostatisticians
ICSSC Services
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Protocol Development
Site Assessment
Data Management
Biostatistics
Training
Etc.
Where is the ICSSC?
Requesting Assistance
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New ICIDR….need HELP?
• Contact your DMID Program Officer
• Contact the International Clinical
Sciences Support Center (ICSSC)
http://www.icssc.org/
Study Protocol
ICH GCP 1.44:
“A document that describes the
objective(s), design, methodology,
statistical considerations, and
organization of a trial.”
ICSSC Protocol Development
Services (1)
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Protocol Pre-Review
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Clarity
Completeness
GCP compliance
Proper use of DMID protocol templates
http://www.niaid.nih.gov/dmid/clinresearch
 DMID Study Product Template
 DMID Specimen Protocol Template: Greater Than
Minimal Risk
 DMID Specimen Protocol Template: Minimal Risk
ICSSC Protocol Development
Services (2)
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In-depth protocol review/assistance
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Study design consultation
Statistical considerations
Implementation planning
Data management plans
CRF development
Safety reporting and monitoring
Good Clinical Practices (GCP)
Informed consent
Protocol development coordination
Process
Choose the research question
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Develop the concept
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WRITE THE PROTOCOL
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Revise/finalize the protocol
(DMID and IRB approval crucial)
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Conduct the study
What To Consider When Writing
The Protocol (1)
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Grant proposal vs. study protocol
Narrow down specific aims to
objectives
Choose appropriate study
design/protocol template
Eliminate all non-applicable template
language from the protocol (use
working shell)
Minimize duplication/ensure
consistency
What To Consider When Writing
The Protocol (2)
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Provide precise information on
study population and case
definitions
List all inclusion/exclusion
criteria
Ensure objectives are linked to
study procedures and statistical
sections
What To Consider When Writing
The Protocol (3)
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Include sufficient detail in protocol
sections like
• Study procedures
• Data management
• Statistical considerations/ analysis
• Safety monitoring and reporting
• Ethical considerations/ Human
subjects protection
•…
What To Consider When Writing
The Protocol (4)
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Keep up with informed consent
issues
• Informed consent(s) included?
• Language simple?
• Enough information about the research?
• Sufficient description of all study visits,
procedures, samples taken?
• Required elements included?
• Separate approval for future use
specimen storage?
Appendices
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Sample informed consent(s)
Schedule of events/visits
Product use directions
Other special procedures
(Data collection forms)
Protocol Amendments
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Informed consent and
protocol are usually approved
together
Any change to either
document requires DMID and
IRB review and approval
Protocol Writing Tips (1)
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Use consistent formatting
Include header/footer with version
and date information
Use reasonable margins
“white space” eases readability
Use numbered section, subsection
titles
Protocol Writing Tips (2)
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Spell out abbreviations (abbr.) and
acronyms (acr.) at first use
Spell out single-digit numbers up
to nine
Use bulleted lists instead of long
paragraphs
Avoid duplication of information
Delete template sections, if not
applicable
Final Hints
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Clear, concise protocol critical to
study success
Start early —
protocol development takes time
Early input and internal peer
review facilitates approval process
later
Expect multiple reviews —
DMID, IRBs and possibly scientific
committees generally provide
comments
Site Assessment Services
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Site assessment -
by investigator or
DMID request
• Needs assessment with
recommendations
• Pre-monitoring assistance
• Good Clinical Practices (GCP)
• DM assessments
• Clinical site, pharmacy, lab
• IRB
• Staff capabilities
• Training
Data Management Services
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Site Assessments
Training
• Investigator workshops
• DM hands on workshop
• At FHI
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Trial Support
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Data management plans
CRF development
Data entry systems
Documentation and validation
ICSSC Biostatistics Services (1)
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Protocol
development/implementation
• Study design consultation
• Endpoint definition
• Sample size determination
• Analysis plan development
• DSMB plans
• Randomization and allocation
concealment procedures
ICSSC Biostatistics Services (2)
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Case report forms review
DSMB
• Interim report preparation
• Independent Statistician
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Final data analysis and
interpretation of results
Preparation of final
report/manuscripts
ICSSC Training Services
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Regional clinical research workshops
• Fundamentals of clinical research
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Data management workshops
Individual data management training at
FHI
Ethics Training
Scientific writing workshop
• Assistance with data and manuscript
preparation for publication.
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GCP training
Study Implementation training
Tools & Resources:
ICSSC website
www.icssc.org
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Research Resources
Presentations
ICSSC Services
Contacts
Request for Assistance
Tools & Resources:
WebEx
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Web-based meeting tool that allows
participants to view documents, annotate
documents, and perform demonstrations
using a variety of software.
Allows investigators to hold on-line
meetings between team members located
around the world.
FHI provides international calling support
in conjunction with WebEx and has
created secure user accounts for all
domestic and foreign PIs who have
requested the use of WebEx.
Summary
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ICSSC can provide support
during protocol development as
well as during the study
planning and implementation
phases
Contact the ICSSC:
http://www.icssc.org/