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.

Keywords: Capacity strengthening; Clinical trials oversight; Emergency preparedness; Evaluation; Public health emergencies; WHO GBT.

Fig. 1

Baseline assessment of WHO Global Benchmarking Tool sub-indicators related to emergency preparedness for clinical trials oversight in VaccTrain’s partner NRAs. Validated self-benchmarking data collected in June – September, 2018 at the onset of our capacity-strengthening partnership was used to assess the availability and implementation status of public health emergency–related sub-indicators (i.e., CT01.01, CT01.05, CT01.11, CT04.07 and CT06.04) as per specific indications in the WHO GBT. A Status of partner NRAs’ emergency preparedness for CTO based on a scoring system that rated sub-indicators by percentage evidence available of individual “evidence to review” items. B Status of partner NRAs’ emergency preparedness for CTO based on WHO criteria which rated sub-indicators as not implemented (NI), ongoing implementation (OI), partially implemented (PI), or fully implemented (I)

Fig. 2

Effect of regulatory capacity strengthening on improving operational structures for clinical trials oversight in preparedness towards public health emergencies. The availability of structures and implementation status of WHO GBT sub-indicators related to CTO during public health emergencies were assessed in November 2021. A Current status of partner NRAs’ operational readiness for public health emergencies using the percentage evidence available scores of individual “evidence to review” items. B Current status of partner NRAs’ operational readiness for public health emergencies using the WHO criteria

Fig. 3

Formal approval and practical implementation status affecting capacity-strengthening achievements for clinical trials oversight-related emergency preparedness. The formal approval of CT legal provisions and regulations as well as their evidence of implementation and that of applicable guidelines and SOPs were investigated. Each ‘evidence to review’ item was scored (i.e., evidence provided = 1; no evidence provided = 0) and the total tally for the three NRAs unified was calculated as percentage evidence available. A The current status of all individual legal provisions and regulations (top panel), guidelines and SOPs (lower panel) of the emergency-related sub-indicators analyzed. B Evidence of implementation status of the emergency-related five sub-indicators analyzed