Minutes from TB Clinical Trials Consultants Meeting, St. George’s, University of London, November 17/18

November 30, 2011

The meeting was convened to catalogue expert opinion on the conduct of Phase 2 and Phase 3 clinical trials in tuberculosis. Phase 2 trials were defined as trials measuring sputum mycobacterial load over time, from two days to two months in duration. Phase 3 trials were defined as definitive clinical outcome trials with long-term follow-up for recurrence (relapse/re-infection). The meeting was organized into six sessions; at each session questions were posed to a panel of experts. Questions for the panelists were prepared by the meeting organizers with input from the meeting attendees and from the TB drug development community at large. The questions were distributed to the panelists and other attendees in advance of the meeting. The other attendees participated in the discussions after the panelists provided their answers.