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

Abstract

Background A stable, well-functioning and integrated national medicines regulatory system is a core component of health systems resilient against infectious disease outbreaks. In many low- and middle-income countries, however, sizable gaps exist in the emergency preparedness framework of national regulatory authorities (NRAs). RegTrain-VaccTrain is a project of Germany Ministry of Health’s Global Health Protection Programme that contributes to global efforts aimed at strengthening such regulatory systems by providing technical support and advice to partner NRAs. In this study, we probed the outputs of our capacity-strengthening activities for clinical trials oversight (CTO) to take stock of progress made and examine remaining priorities in order to provide specialized technical assistance in addressing them to improve operational readiness for emergencies. Method Data validated from NRA self-benchmarking results in 2017 and worksheet records of November 2021 were utilized to assess the emergency preparedness capacity for CTO in three VaccTrain partner NRAs (Liberia, Sierra Leone, The Gambia) before and after interventional capacity-strengthening partnership, using specific public health emergency-related (sub-)indicators of the WHO Global Benchmarking Tool. Results A generally weak and vulnerable structural framework for CTO characterized the emergency preparedness capacity in all three partner NRAs at baseline, thus putting their operational readiness for public health emergencies at risk. VaccTrain’s collaborative work was successful at supporting individual NRAs to develop the full spectrum of operational structures (including (draft) regulations, guidelines, and standard operating procedures) required to improve regulatory preparedness. A gap in the formal approval and implementation of developed legal documents in two of three NRAs still remains. Notwithstanding, a robust emergency framework now exists and the NRAs stand better prepared to respond to (future) locally-concerning health emergencies, during which time clinical trials activity was observed to heighten. Conclusions These results exemplify a north-south capacity-strengthening partnership model that effectively contributes in developing structures to enhance regulatory oversight and support expeditious product development in response to crises. They further underscore the equally critical role local/national processes play in facilitating the full implementation of developed structures.

Benchmarking Drug Regulatory Systems for Capacity Building: An Integrative Review of Tools, Practice and Recommendations

“…The description of 43 articles is presented in Table 1 . 11 - 15 , 18 - 20 , 26 - 60 The research design included literature review (n = 3), 28 , 32 , 49 expert interview (n = 1), 48 empirical analysis (n = 2), 43 , 52 comparative analysis (n = 7), 12 , 15 , 35 , 42 , 47 , 58 , 59 retrospective analysis (n = 2), 19 , 41 questionnaire (n = 10), 14 , 20 , 26 , 27 , 37 - 40 , 55 , 56 description analysis (n = 6), 11 , 13 , 33 , 36 , 45 , 60 and mixed methods (n = 12). 18 , 29 - 31 , 34 , 44 , 46 , 50 , 51 , 53 , 54 , 57…”

“… 25 , 43 , 57 , 58 The remaining 4 studies aimed to assess the regulatory functionalities related to pharmacovigilance, 28 , 37 vaccines 11 and clinical trials. 12 …”

“…Among the 43 included studies, 15 studies covered multiple regulatory functions 11 , 13 , 15 , 18 , 20 , 27 , 32 - 34 , 42 , 44 , 45 , 50 , 54 , 57 while the remaining 28 studies focused on only 1 function when evaluating the regulatory capacities of NRAs. 12 , 14 , 19 , 26 , 28 - 31 , 35 - 41 , 43 , 46 - 49 , 51 - 53 , 55 , 56 , 58 - 60 Apart from 6 of the studies 11 , 13 , 18 , 27 , 32 , 42 which fully adopted the 9 GBT indicator categories when evaluating the functions of interest, the remaining studies adopted only some of the GBT indicator categories and sub-indicators whenever deemed relevant by the researchers. In 5 studies, 12 , 15 , 29 , 33 , 34 a combination of indicators from different benchmarking tools or programmes were used as measurements of the regulatory capacities.…”

“…Given the growing interests in benchmarking drug regulatory systems, it becomes highly relevant to see what research and country experiences has had to say about this phenomenon. Previous literature mainly focused on a number of aspects of regulatory benchmarking including: the introduction of the practice of benchmarking NRA 11 ; the application of benchmarking NRAs for different purposes such as public health emergencies 12 , 13 and pharmacovigilance 14 , 15 ; various benchmarking tools or programmes such as the Global Benchmarking Tool (GBT) developed by the World Health Organization (WHO), 16 and Optimizing Efficiencies in Regulatory Agencies (OpERA) 17 ; and the country experiences of assessing and comparing regulatory capacities using benchmarking. 15 , 18 - 20 However, such literature is yet to be systematically analyzed and reviewed to depict an overall research landscape about how regulatory capacities can be approved through benchmarking NRAs.…”

Capacity Assessment of the National Medicines Regulatory Authority in a Low -income Country

“…Owusu-Seykere and others in 2022 used the WHO-GBT as a leverage to capacity strengthening in regulatory systems, although it was limited to clinical trial oversight in public health emergencies. It revealed weak and vulnerable structures before partnership with stringent regulatory authorities at baseline and how strong and prepared these NMRAs are currently in terms of clinical trial oversight during emergencies involving public health [9].…”