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System for Efficacy and Cytotoxicity Screening of Inhibitors Targeting Intracellular Mycobacterium tuberculosis
Published on: April 5, 2017
Building clinical trial capacity to develop a new treatment for multidrug-resistant tuberculosis
Thelma Tupasi1, Rajesh Gupta2, Manfred Danilovits3
1Tropical Disease Foundation, Makati City, Philippines .
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: (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 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.
Insights
Capacity-building programs are essential for conducting clinical trials of new infectious disease drugs in low-resource settings. These programs enhance local expertise in trial design, data management, and regulatory compliance, ultimately improving global health systems.
Area of Science:
- Global Health
- Clinical Trials
- Infectious Diseases
Background:
- New infectious disease drugs require evaluation in diverse settings, including low-resource areas.
- Local healthcare professionals often possess high-quality care skills but may lack experience in drug approval clinical trials.
- Stringent regulatory authority requirements necessitate specialized trial conduct capabilities.
Purpose of the Study:
- To implement and assess a capacity-building program during a multi-center randomized controlled trial for delamanid, a multidrug-resistant tuberculosis treatment.
- To enhance the ability of healthcare professionals in low-resource settings to conduct clinical trials meeting international standards.
Main Methods:
- A comprehensive capacity-building program was integrated into a multi-center randomized controlled trial.
- Key components included site needs assessment, achieving International Conference on Harmonization - Good Clinical Practice (ICH-GCP) standards, trial management establishment, and regulatory knowledge enhancement.
- Trials were conducted across 17 sites in nine countries, with 80% of low-resource sites having no prior experience in such trials.
Main Results:
- The capacity-building program successfully enhanced local expertise across all 10 targeted low-resource sites.
- Significant improvements were observed in trial design, data safety and monitoring, trial conduct, and laboratory services.
- The program demonstrated the feasibility of building robust clinical trial capabilities in resource-limited environments.
Conclusions:
- Conducting clinical trials for regulatory drug approval demands specialized capacity-building beyond traditional research strengthening.
- These targeted capacity-building initiatives can significantly improve health systems and support product development partnerships.
- Investing in local expertise is crucial for advancing global health and ensuring equitable access to new medicines.
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