CPTR Key Accomplishments: Research Resources Group

1. CPTR Key Accomplishments:Research Resources Group October 3, 2012

2. CPTR Structure Research Resources Group Regulatory Science Consortium ADVISORY PANEL Drug Development Coalition

3. CPTR Structure Research Resources Group Regulatory Science Consortium Drug Development Coalition

4. Value of Consortium Approach Ensuring an Ethical Process Access & Appropriate Use Of New Drugs Clinical Trial Capacity Research Resources Stakeholder Engagement Resources Needs & Funding Global Regulatory Pathways

5. Research Resources Group: Mission 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

6. Research Resources Group: Workgroups

7. Access & Appropriate Use • Key Accomplishments • Paper on Compassionate Use and Expanded Access accepted and awaiting publication in the InternationalJournal 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

8. 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

9. Clinical Trials Database Example

10. 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

11. Requirements for Joint Review

12. 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

13. 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.

14. Thankyou