A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project

A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project

<p>Abstract</p> <p>Background</p> <p>There have been no major advances in tuberculosis (TB) drug development since the first East African/British Medical Research Council short course chemotherapy trial 35 years ago. Since then, the landscape for conducting TB clinical...

Full description

Bibliographic Details
Main Authors: Merle Corinne SC, Sismanidis Charalambos, Sow Oumou, Gninafon Martin, Horton John, Lapujade Olivier, Lo Mame, Mitchinson Denis A, Perronne Christian, Portaels Francoise, Odhiambo Joseph, Olliaro Piero, Rustomjee Roxana, Lienhardt Christian, Fielding Katherine
Format: Article
Language:English
Published: BMC 2012-05-01
Series:Trials
Subjects:
Randomized controlled trial
Tuberculosis treatment
Non-inferiority design
Multicenter
Design issues
Phase III
Gatifloxacin
Online Access:http://www.trialsjournal.com/content/13/1/61

Internet

http://www.trialsjournal.com/content/13/1/61

Similar Items