- All > Quality and Safety: Medicines > Quality Assurance
- All > Quality and Safety: Medicines > Regulatory Support
- Keywords > clinical laboratory - capacity building
- Keywords > clinical trials - capacity building
- Keywords > clinical trials conducted - new medicines approved/New Drug Application (NDA)
- Keywords > clinical trials in humans
- Keywords > controlled clinical trials
- Keywords > efficacy and safety of medicines
- Keywords > Good Clinical Practice (GCP)
- Keywords > Good Manufacturing Practices (GMP)
- Keywords > investigational product - clinical trials
- Keywords > Multidrug-resistant Tuberculosis (MDR-TB)
(2016; 6 pages)
Problem: 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.
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. The programme included:
- site identification and needs assessment;
- achieving International Conference on Harmonization – Good Clinical Practice (ICH-GCP) standards;
- establishing trial management; and
- increasing knowledge of global and local regulatory issues.
Local setting: 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.
Relevant changes: 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.
Lessons learnt: 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.