CPTR Key Accomplishments:Research Resources GroupOctober 3, 2012
CPTR Structure
Regulatory Science Consortium
Research Resources Group
Drug Development Coalition
ADVISO
RY PANEL
CPTR Structure
Regulatory Science
Consortium
Research Resources Group
Drug Development
Coalition
Ensuring an Ethical Process
Clinical Trial Capacity
Resources Needs & Funding
Stakeholder Engagement
Access & Appropriate
Use Of New Drugs
Value of Consortium Approach
Global RegulatoryPathways
ResearchResources
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Increase the likelihood of successful TB drug development by developing resources and creating the infrastructure necessary to support the development of novel TB regimens
The goals of the CPTR Research Resources Group are to work collaboratively with CPTR partners to identify and address challenges in regimen development, including:
• Supporting capacity-building activities for TB clinical trial sites• Soliciting global participation in addressing regulatory challenges• Promoting engagement all stakeholders involved in a TB trial• Fostering access to new TB therapies and ensuring appropriate use
Research Resources Group: Mission
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Research Resources Group: Workgroups
Access & Appropriate Use Workgroup
• Increase access to TB therapy by those in greatest need both before and after formal approval
• Shorten normative, regulatory, and policy processes to accelerate access to life-saving TB therapies
Clinical Trials Infrastructure Workgroup
• Increase clinical trial and laboratory site capacity and quality
Global Regulatory Pathways Workgroup
• Identify and address challenges in the current regulatory process
• Identify and promote new and existing regulatory pathways to facilitate efficient review processes
Stakeholder & Community Engagement Workgroup
• Identify and develop resources to facilitate participatory approaches within TB drug trials
• Ensure effective and appropriate stakeholder and community engagement in TB drug trials
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Access & Appropriate Use
• Key Accomplishments– Paper on Compassionate Use and Expanded Access accepted and
awaiting publication in the International Journal of TB and Lung Diseases
• Next Steps– Expanding the understanding of challenges related to pre-approval
and post-approval access to TB drugs/drug regimens to determine appropriate next steps
– Working to facilitate the uptake of WHO recommendations on compassionate use
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Clinical Trials Infrastructure
• Key Accomplishments– Providing a forum for clinical trial networks, donors, and researchers
to discuss collaborations at annual TB Union meetings– Developing the TB Clinical Trial Online Database which links
experienced TB sites with groups looking for this capacity
• Next Steps– Developing commonly-agreed standards for assessing and ensuring
quality of mycobacterial laboratories
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Clinical Trials Database Example
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Global Regulatory Pathways
• Key Accomplishments– Laying the groundwork for joint regional review for TB clinical trials
and marketing authorizations which aim to increase the efficiency of review processes
• Next Steps– Present concepts for joint review and other modified regulatory
pathways to global audience to get feedback and support
Requirements for Joint ReviewKey Required Elements
Manufacturer/Sponsor • Agreement to participate, as owners of the data
NRAs • Consensus from all countries involved on the joint process or ‘accepted’ review
• Designated person from each country involved to participate in review process
Experts • Conduct review and/or support NRA staff working through review and questions
Neutral Support Partner
• Facilitate the review procedure and information dissemination
• Provide venue for discussion
Funding Source • Cover associated expenses (e.g. information dissemination, meetings, travel, etc.)
All • Agreement on format of submission• Agreement on timeframe of specific activities
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Stakeholder & Community Engagement
• Key Accomplishments– Released the Good Participatory Practice Guidelines for TB Drug
Trials (GPP-TB) which provides a principle-based framework for effective engagement of all stakeholders and works towards establishing a common language for incorporating a participatory approach to TB drug research
• Next Steps– Developing tools and materials to facilitate the implementation of
the GPP-TB– Identifying clinical trial sites to ‘pilot’ the GPP-TB
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Objective of the GPP-TB Guidelines
• Encourage greater attention to community interests
• Help establish shared standards, expectations, and accountability for effective and outcome-driven engagement throughout all phases of TB drug trials.
Thank you
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