IFGH 2012: Capacity Building Through TB Regimen Development

Authors:Spigelman M.1, Mendel C.1, Everitt D.1, van Neikerk C.2, Uys A.2, Gardiner E.1, Wells W.1, Barve A.1

Author Affiliations: 1Global Alliance for TB Drug Development, New York, USA, 2Global Alliance for TB Drug Development, Pretoria, South Africa

Option 2– Lessons from the field; project and programme evaluations; and syntheses or analyses

Presented as – Oral Poster

Issues:

A number of TB drug candidates are entering the clinic; however, capacity to conduct registration-standard trials is weak or lacking in many low- and middle-income countries with high TB burdens where trials will take place.

Description:

In conjunction with several Phase II and III studies, the TB Alliance invested in human capacity building at clinical sites and their associated laboratories. Training was provided to clinic and trial management staff on patient management, quality assurance, product management and appropriate storage, administrative support and data management. Laboratory staff received training on specimen handling, safety and the operation of laboratory machinery. To strengthen community-researcher relations, instruction on technical aspects of TB drug trials and adult education methods was also provided to clinic staff with community-facing roles and Community Advisory Boards.

Lessons learned:

Capacity building for registration trials requires initial training as well as continual monitoring and targeted retraining throughout the duration of the trial to address specific challenges that arise. Building laboratory capacity proved to be challenging and required more intensive capacity building than clinical operations. Skills-building and education aimed at improving community engagement aids trial recruitment and retention, and creates trustful relationships between trial staff and the local population, which in turn facilitates the conduct of research.

Next steps:

With the abundance of TB candidates reaching late-stage trials, greater investments will be made to increase the number of sites with capacity for Phase II and III registration-standard clinical studies for TB drugs. Efforts to strengthen lab staff capacity will be intensified by producing and rolling out a standard lab procedures manual. Sustaining capacity is a concern and research sponsors and funders must coordinate in queuing clinical studies to retain staff. Activities to capacitate trial staff for successful engagement with the community will be expanded to future TB drug trials.