Strengthening capacity for clinical research in sub-Saharan Africa: partnerships and networks

Abstract

This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Leveraging WHO’s Global Benchmarking Tool to strengthen capacity in clinical trials oversight for public health emergencies: the GHPP VaccTrain model

“…These differences, together with those in the formal approval pathways in the different regulatory jurisdictions, means that some get approved faster while others may require extra support in advocacy to facilitate approval and enforcement. This data further confirmed earlier findings that building capacity to conduct effective CT (or its oversight in this case) and achieving its full benefits is a process that grinds slowly and requires a long-term perspective [ 12 ]. Capacity building projects that seek to build an effective, impactful and sustainable CTO infrastructure in partner NRAs should therefore be guided by this fact and factor it into their planning.…”

“…Since the Ebola outbreak in 2014, regulatory capacity strengthening in LMICs has attracted much attention as a global priority [ 8 , 18 ]. The idea of the need for global collaborations to foster the development agenda is being further promoted [ 7 , 12 ]. In our bid to support partner NRAs build emergency measures to improve access to essential health products and technologies for response and mitigation, the VaccTrain employs a strategy that thrives on the development and implementation of regulatory structures/documents as its centerpiece.…”

“…Strengthening regulatory capacities in LMICs to promote effective emergency responsiveness requires strong partnerships and regulatory collaborations. It is opined that functional emergency preparedness and responsiveness by NRAs in LMICs could be more effectively achieved if current efforts to strengthening them are supported and accelerated [ 8 , 12 ]. Such capacity-strengthening partnerships and support systems, which the WHO asserts to be the most frequently mentioned priority in their country cooperation engagements [ 8 ], are vital in achieving impactful and sustainable public health outcomes and advancement of health and development [ 8 , 13 ].…”

Blue Skies research is essential for ending the Tuberculosis pandemic and advancing a personalized medicine approach for holistic management of Respiratory Tract infections.

“…Furthermore, the cost of new innovations is high and thus are perceived as not affordable or implementable in developing countries. This has developed the status quo that most funder investments and grant based research activities in high TB endemic countries are focussed on clinical trials research evaluating new TB tools and drug regimens discovered in wealthier nations, or on implementation and operational research (Zumla et al, 2015b;Nyirenda T et al, 2021). This status quo and the mindset of funders and LMIC stakeholders is now unacceptable and needs to change.…”

“…Unique opportunities now arise with the growing portfolio of trained scientists, clinical trials networks and laboratory infrastructures in LMICs (Nyirenda T et al, 2021;Zumla et al, 2015b). These…”