CPTR Key Accomplishments:Research Resources GroupOctober 3, 2012

CPTR Structure

Regulatory Science Consortium

Research Resources Group

Drug Development Coalition

ADVISORY PAN

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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 dataNRAs • 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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