Statement from University of St Andrews on Completion of Enrollment in REMox TB

January 31, 2012

Dr Stephen H. Gillespie MD DSc

Sir James Black Professor of Medicine

University of St Andrews University

Chief Investigator

For me, the completion of recruitment to the REMox TB trial represents an important milestone on a tremendous journey, since Andrew Nunn and I sat down to sketch out the original research proposal more than eight years ago! A positive result from this trial will have important implications for individual patients, and tuberculosis treatment programmes. As the first regulatory trial for tuberculosis, we have wrestled successfully with developing a protocol relevant to the current environment. New clinical and laboratory capacity has been developed in high-burden countries, a comprehensive standardized laboratory manual has been developed and implemented, and a system for medical monitoring has been established. Developing the systems for the trial and managing the multiple ethical review boards, national regulators, translating materials and protocols into multiple languages, and delivering drug to a range of high-burden countries, while maintaining defined, high standards have proven enormously challenging. In response, the REMox TB team has worked together tirelessly to achieve this important milestone. The embedded methodology research will inform future trials, most notably in relation to the interpretation of laboratory tests that were not available when the previous series of clinical trials were performed more than 40 years ago. Thus, I believe that REMox TB has generated an enormous amount of learning in how to deliver a regulatory-grade tuberculosis trial for the future.

Ultimately, REMoxTB is about people: the patients with tuberculosis who have participated in the trial and attended multiple visits in the hope that their effort will improve the lot of other patients, the site investigators who have recruited and managed the patients and performed the hard work of documenting the trial, the colleagues from the TB Alliance, University College London and the United Kingdom Medical Review Council who have worked consistently to overcome the many challenges of implementation. It has been a privilege for me to have been part of this study.