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

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.

Good collaborative practice: reforming capacity building governance of international health research partnerships

“…Increasingly, international collaborative research is being asked to consider the local interests of resource-constrained partners and the responsibility of collaborations to safeguard against the potential for structural exploitation when operating in resource-constrained settings [ 6 , 14 ]. In some instances, research partnerships have actively (and explicitly) incorporated capacity building objectives in conjunction with disease and intervention research [ 4 , 15 – 18 ]. This approach has not only been regarded as ethical but also essential for responding to local health needs, through bolstering both the health-related social structures, and addressing the urgent health needs of the affected populations [ 6 , 19 ].…”

Capacity Building in Sub-Saharan Africa as Part of the INTENSE-TBM Project During the COVID-19 Pandemic

“…Developing new strategies to tackle TBM and other emerging or re-emerging diseases, including COVID-19, requires clinical research [ 19 – 21 ]. The major global burden of communicable diseases is borne by SSA, but, in stark contrast, this region is only a minor beneficiary of clinical research funding [ 19 , 21 , 22 ].…”

“…Developing new strategies to tackle TBM and other emerging or re-emerging diseases, including COVID-19, requires clinical research [ 19 – 21 ]. The major global burden of communicable diseases is borne by SSA, but, in stark contrast, this region is only a minor beneficiary of clinical research funding [ 19 , 21 , 22 ]. Although highly competitive institutions have increased their presence in some countries in the region, many other countries lack such research capacity and are left behind; hence, resources remain centralised and significant disparities persist both between and within countries [ 20 , 23 ].…”

“…In this context, clinical research combined with capacity building is an effective strategy to promote fairer resource distribution, to redress healthcare inequalities and to achieve minimum research capacity. These three features are crucial to the fight against endemic diseases and the prevention of future outbreaks [ 19 – 21 , 23 ]. Moreover, research platforms developed for a given disease (e.g.…”

Clinical Research in Neglected Tropical Diseases: The Challenge of Implementing Good Clinical (Laboratory) Practices

“…Building clinical trials capacity at research-naïve sites and institutions in LMICs is always challenging, and this is particularly true for NTD research, which has traditionally received less attention and support compared to other medical fields, such as HIV/AIDS, malaria, and tuberculosis; however, it is feasible [25]. Based on the experience of the NIDIAG consortium, we believe that GC(L)P principles and requirements can and should be implemented in NTD clinical research to ensure protection of patients and communities and to ensure data reliability.…”