Addressing challenges for clinical research responses to emerging epidemics and pandemics: a scoping review

Louise Sigfrid,Mike Clarke,Gail Carson,Sharif A Ismail,Peter G Bannister,Nina Gobat,Katherine Maskell,Sadie Regmi,Kajsa-Stina Longuere,Claire Blackmore,Shelui Collinson,Eli Harriss,Peter Horby

doi:10.1186/s12916-020-01624-8

Abstract

BackgroundMajor infectious disease outbreaks are a constant threat to human health. Clinical research responses to outbreaks generate evidence to improve outcomes and outbreak control. Experiences from previous epidemics have identified multiple challenges to undertaking timely clinical research responses. This scoping review is a systematic appraisal of political, economic, administrative, regulatory, logistical, ethical and social (PEARLES) challenges to clinical research responses to emergency epidemics and solutions identified to address these.MethodsA scoping review. We searched six databases (MEDLINE, Embase, Global Health, PsycINFO, Scopus and Epistemonikos) for articles published from 2008 to July 2018. We included publications reporting PEARLES challenges to clinical research responses to emerging epidemics and pandemics and solutions identified to address these. Two reviewers screened articles for inclusion, extracted and analysed the data.ResultsOf 2678 articles screened, 76 were included. Most presented data relating to the 2014–2016 Ebola virus outbreak or the H1N1 outbreak in 2009. The articles related to clinical research responses in Africa (n = 37), Europe (n = 8), North America (n = 5), Latin America and the Caribbean (n = 3) and Asia (n = 1) and/or globally (n = 22). A wide range of solutions to PEARLES challenges was presented, including a need to strengthen global collaborations and coordination at all levels and develop pre-approved protocols and equitable frameworks, protocols and standards for emergencies. Clinical trial networks and expedited funding and approvals were some solutions implemented. National ownership and community engagement from the outset were a key enabler for delivery. Despite the wide range of recommended solutions, none had been formally evaluated.ConclusionsTo strengthen global preparedness and response to the COVID-19 pandemic and future epidemics, identified solutions for rapid clinical research deployment, delivery, and dissemination must be implemented. Improvements are urgently needed to strengthen collaborations, funding mechanisms, global and national research capacity and capability, targeting regions vulnerable to epidemics and pandemics. Solutions need to be flexible to allow timely adaptations to context, and research led by governments of affected regions. Research communities globally need to evaluate their activities and incorporate lessons learnt to refine and rehearse collaborative outbreak response plans in between epidemics.

Highlights

Major infectious disease outbreaks are a constant threat to human health
Of the 2673 articles identified through database searching, 234 full-text records were screened for inclusion, 71 of these met the inclusion criteria
Most articles presented challenges and solutions identified during the Ebola virus epidemic in 2014 to 2016 and/or during the H1N1 pandemic in 2009

Summary

Introduction

Major infectious disease outbreaks are a constant threat to human health. Clinical research responses to outbreaks generate evidence to improve outcomes and outbreak control. Experiences from previous epidemics have identified multiple challenges to undertaking timely clinical research responses. Activities have improved collective preparedness to respond to public health emergencies [1, 2], experiences from previous outbreaks have highlighted many ongoing challenges for clinical research responses to epidemics [3, 4]. Some of these stem from the inherently unpredictable nature of emerging infections. Previous epidemics have generated important information that has helped inform preparedness and response; it has highlighted systemic challenges to our global capability to address important clinical research questions in these environments [1]. Conducting research under emergency conditions requires agility, intense activity, flexibility and adaptability to context [3, 4]

Methods

Results

Discussion

Conclusion