Abstract
ProblemNew drugs for infectious diseases often need to be evaluated in low-resource settings. While people working in such settings often provide high-quality care and perform operational research activities, they generally have less experience in conducting clinical trials designed for drug approval by stringent regulatory authorities.ApproachWe carried out a capacity-building programme during a multi-centre randomized controlled trial of delamanid, a new drug for the treatment of multidrug-resistant tuberculosis. The programme included: (i) site identification and needs assessment; (ii) achieving International Conference on Harmonization – Good Clinical Practice (ICH-GCP) standards; (iii) establishing trial management; and (iv) increasing knowledge of global and local regulatory issues.Local settingTrials were conducted at 17 sites in nine countries (China, Egypt, Estonia, Japan, Latvia, Peru, the Philippines, the Republic of Korea and the United States of America). Eight of the 10 sites in low-resource settings had no experience in conducting the requisite clinical trials.Relevant changesExtensive capacity-building was done in all 10 sites. The programme resulted in improved local capacity in key areas such as trial design, data safety and monitoring, trial conduct and laboratory services.Lessons learntClinical trials designed to generate data for regulatory approval require additional efforts beyond traditional research-capacity strengthening. Such capacity-building approaches provide an opportunity for product development partnerships to improve health systems beyond the direct conduct of the specific trial.
Highlights
New medicines are needed for multidrug-resistant (MDR) tuberculosis[4] and most of the people infected with MDR tuberculosis live in low-income countries, where there is often insufficient capacity to conduct clinical trials that meet the International Conference on Harmonization – Good Clinical Practice (ICH-GCP) standards.[5,6,7,8]
We describe a global clinical trial capacity-building programme done in the context of trials for delamanid conducted to achieve approval by a stringent regulatory authority
The trials were conducted from May 2008 to May 2012 at 17 sites in nine countries (China, Egypt, Estonia, Japan, Latvia, Peru, the Philippines, the Republic of Korea and the United States of America) with 481 participants completing trial 204 and 421 of these continuing into trial 116
Summary
Building clinical trial capacity to develop a new treatment for multidrug-resistant tuberculosis. While people working in such settings often provide high-quality care and perform operational research activities, they generally have less experience in conducting clinical trials designed for drug approval by stringent regulatory authorities. Approach We carried out a capacity-building programme during a multi-centre randomized controlled trial of delamanid, a new drug for the treatment of multidrug-resistant tuberculosis. Lessons learnt Clinical trials designed to generate data for regulatory approval require additional efforts beyond traditional researchcapacity strengthening. Such capacity-building approaches provide an opportunity for product development partnerships to improve health systems beyond the direct conduct of the specific trial
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