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Table 3 Key actions identified

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

Domain

Key actions identified

Political and economic challenges

Establish effective, coordinated, equitable collaborations between international and national organisations involved in public health emergencies at all levels [1, 3, 7, 13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40]

Establish dedicated funding and coordinated, accelerated funding mechanisms [1, 13, 15, 19,20,21,22, 24, 26, 27, 31,32,33,34,35, 37,38,39, 41]

Invest in health systems and infrastructure strengthening, targeting epidemic-prone regions [1,2,3, 13, 17, 29, 31, 32, 36, 42,43,44]

Invest in sustainable clinical research centres and research training [1, 3, 5, 6, 15,16,17, 20, 22, 29, 31, 33, 38, 44,45,46,47,48]

Incentivise clinical research response networks [1, 6, 15, 20, 22, 24, 31, 33, 37, 38, 41, 45, 48, 49]

Engage stakeholders in affected countries from inception [1, 3, 13, 16,17,18,19, 22, 26, 29, 31, 32, 36, 38, 40, 44, 50, 51]

Administrative, regulatory and logistic challenges

Develop human resource and research capacity [1, 3,4,5,6, 13, 15,16,17, 20, 22, 29, 31, 33, 36, 38,39,40, 42,43,44,45,46, 48, 50, 52]

Train researchers, clinicians and other stakeholders for rapid deployment [1, 36, 38, 41, 53]

Develop international and national research, administrative and logistics support platforms [1, 3, 4, 18, 20, 29, 32, 42, 43, 45, 47, 50,51,52, 54,55,56] with funded coordinating mechanisms [39]

Agree R&D frameworks and standards for emergencies [2, 5,6,7, 13, 14, 18, 19, 21, 22, 24, 26, 27, 35, 37, 39,40,41, 51, 52, 54, 57,58,59,60] include national stakeholders [26, 38] and systems for evaluating the impact, regular reviews and updating [19]

Develop pre-designed and pre-approved study protocols and associated tools for different scenarios [1, 3, 4, 13, 15, 17, 20, 29, 34, 37, 41, 46, 48, 50, 51, 55, 56, 61,62,63]

Establish accelerated pathways for regulatory and ethical joint approvals [1, 2, 6, 7, 13, 18, 20, 21, 32, 34, 37, 40, 41, 45, 49, 51, 53, 56, 64,65,66]

Set up pre-approved site agreements [4, 15, 38, 45, 46, 48, 61]

Establish international data and sample sharing agreements and templates [7, 13, 18, 20, 22, 24, 25, 27, 28, 35, 44, 48, 52, 57, 58, 62, 67, 68]

Establish coordinated, effective internal and external stakeholder communication and communication plans [3, 5, 14, 16, 18, 20, 23, 25, 29, 32, 34, 42, 46, 58, 65, 69,70,71,72]

Ethical emergency publication agreements with focus on timely, open data sharing [2, 22, 38, 52, 68, 73]

Ethical and social challenges

Explore and trial less complex consent models during emergencies [2, 6, 15, 25, 32, 37, 44, 46, 48, 51, 69, 70, 74]

Develop frameworks for ethical and scientifically robust study designs for various epidemic and pandemic scenarios [6, 13, 14, 17,18,19, 22, 27, 34, 36, 40, 42, 48, 51, 60, 61, 66, 75,76,77]

Develop international guidelines on ethical standards and conduct for emergencies, including inclusion of vulnerable groups [5, 18, 21, 22, 27, 40, 44, 50, 51, 59, 60, 62, 69, 77, 78], and equitable access to care and compensation [44, 59, 77, 79]

Engage and empower communities and stakeholder from the outset [1, 3, 5, 14, 16, 17, 19, 20, 23, 26, 29, 32, 36, 39, 40, 42, 44, 50, 51, 54, 69, 71, 72, 79, 80]