Statement from University College London on Completion of Enrollment in REMox TB

January 31, 2012

Dr. Tim McHugh

Director University College London (UCL) Centre for Clinical Microbiology – REMox TB UCL Lead

The microbiology laboratory is central to any treatment trial for tuberculosis. The microbiological data are the key measure of the success of the treatment and therefore must be robust. The UCL laboratory team has implemented standardised microbiological procedures across all 12 laboratories to ensure reproducibility of data – such a high degree of harmonisation in a TB trial is unique to REMox TB.

REMox TB has supported upgrade and construction of critical infrastructure – laboratory facilities to international operational and safety standards – creating a network of facilities that already are contributing to the next phase of TB drug development. The REMoxTB laboratory and quality manual has been adopted as a template for future clinical trials in TB.

Development of facilities is of no value without the concomitant investment in staff. REMox TB has enabled sites to employ, train and maintain staff proficient in all aspects of clinical trials delivery and, importantly, laboratory staff who have developed expertise in tuberculosis microbiology and the very latest diagnostic tools. Although focussed on diagnosis in the context of the trial, the skills and expertise gained in adoption of best practice and new technologies by trial staff are reflected in delivery of the normal diagnostic service, thus contributing to raised standards of care across the healthcare system as a whole.

REMox TB is a complex trial to organise, with multiple partners from different countries and different institutional cultures. It is a testament to the skill of the Sponsor training teams (including members from University College London, TB Alliance and contract research organizations) that the goals of the study have been so successfully communicated and – as we close recruitment – begin to be fulfilled.

Hopefully, the ultimate outcome of REMox TB will be a new regimen for the treatment of TB. The study leaves a substantial legacy in the network of trials sites prepared to test the next generation of compounds and regimens. However, of equal significance is the contribution to clinical trial design; including the development of protocols and procedures for all aspects of this regulatory trial, addressing the issues of drug and placebo delivery in a double-blinded study conducted in sites with limited pharmacy support and microbiology laboratory monitoring processes beyond the current industry standard. These developments are informing the dialogue on the design of future trials. It is fair to say that REMox TB has made a contribution far beyond the initial treatment question.