Journal Article

Building clinical trial capacity to develop a new treatment for multidrug-resistant tuberculosis

Sanchez-Garavito, Epifanio, Wells, Charles D, Danilovits, Manfred, Gao, Mengqiu, Vargas-Vasquez, Dante E, Cirule, Andra, Cabrera-Rivero, Jose L, Awad, Mohamed, Tupasi, Thelma, Geiter, Lawrence J, Xiao, Heping, Gentry, Leesa M, Gupta, Rajesh

2016

Overview

New 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. 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. 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. Trials 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. Extensive 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. Clinical 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.

• Publisher: World Health Organization
• Subject: Antitubercular Agents - therapeutic use / Approval / Building authorities / Capacity Building - organization & administration / Capacity Building - standards / Capacity building approach / Capacity development / Clinical medicine / Clinical Protocols / Clinical research / Clinical trials / Corporate sponsorship / Design / Disease / Documentation / Drug abuse / Drug Approval / Drug resistance / Drugs / Health care / Health services / Humans / Infectious diseases / International / International conferences / International Cooperation / Laboratories / Lessons from the Field / Medical research / Multidrug resistant organisms / Mycobacterium / Nitroimidazoles - therapeutic use / Operations research / Organizational research / Oxazoles - therapeutic use / Partnerships / Patients / Pharmaceuticals / Prescription drugs / Product development / Quality of care / Regulatory approval / Research Design / Review boards / Treatment programs / Tuberculosis / Tuberculosis, Multidrug-Resistant - drug therapy