Priority Needs for Conducting Pandemic-relevant Clinical Research With Children in Europe: A Consensus Study With Pediatric Clinician-researchers

Micaela Gal, Nina Gobat, Nicholas A. Francis, Kerenza Hood, Christopher C. Butler, Julia Bielicki, Pieter L. Fraaij, Mike Sharland, Jessica Jarvis, Annemarie M. C. van Rossum, Terho Heikkinen, Federico Martinon-Torres, Jethro Herberg, Angela Watkins, Steve A. R. Webb, Ronnie Moore, Prasanth Sukumar, Alistair Nichol

Research output: Contribution to journalArticle

Abstract

Background: Infectious disease (ID) pandemics pose a considerable global threat and can disproportionately affect vulnerable populations including children. Pediatric clinical research in pandemics is essential to improve children's healthcare and minimize risks of harm by interventions that lack an adequate evidence base for this population. The unique features of ID pandemics require consideration of special processes to facilitate clinical research. We aimed to obtain consensus on pediatric clinician- researchers' perceptions of the priorities to feasibly conduct clinical pediatric pandemic research in Europe.

Methods: Mixed method study in 2 stages, recruiting pediatric clinicianresearchers with experience of conducting pediatric ID research in clinical settings in Europe. Stage 1 was an expert stakeholder workshop and interviews. Discussions focused on participant's experience of conducting pediatric ID research and processes to facilitate pandemic research. Information informed stage 2, an online consensus survey to identify pediatric inician- researchers priorities to enable ID pandemic research.

Results: Twenty-three pediatric clinician-researchers attended the workshop and 39 completed the survey. Priorities were primarily focused on structural and operational requirements of research design and regulation: (1) clarity within the European Clinical Trials Directive for pediatric pandemic research; (2) simplified regulatory processes for research involving clinical samples and data; and (3) improved relationships between regulatory bodies and researchers.

Conclusions: Results suggest that changes need to be made to the current regulatory environment to facilitate and improve pediatric research in the pandemic context. These findings can provide expert evidence to research policy decision-makers and regulators and to develop a strategy to lobby for change.

Original languageEnglish
Pages (from-to)E82-E86
Number of pages5
JournalPediatric Infectious Disease Journal
Volume38
Issue number5
DOIs
Publication statusPublished - May 2019

Cite this

Gal, Micaela ; Gobat, Nina ; Francis, Nicholas A. ; Hood, Kerenza ; Butler, Christopher C. ; Bielicki, Julia ; Fraaij, Pieter L. ; Sharland, Mike ; Jarvis, Jessica ; van Rossum, Annemarie M. C. ; Heikkinen, Terho ; Martinon-Torres, Federico ; Herberg, Jethro ; Watkins, Angela ; Webb, Steve A. R. ; Moore, Ronnie ; Sukumar, Prasanth ; Nichol, Alistair. / Priority Needs for Conducting Pandemic-relevant Clinical Research With Children in Europe: A Consensus Study With Pediatric Clinician-researchers. In: Pediatric Infectious Disease Journal. 2019 ; Vol. 38, No. 5. pp. E82-E86.
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abstract = "Background: Infectious disease (ID) pandemics pose a considerable global threat and can disproportionately affect vulnerable populations including children. Pediatric clinical research in pandemics is essential to improve children's healthcare and minimize risks of harm by interventions that lack an adequate evidence base for this population. The unique features of ID pandemics require consideration of special processes to facilitate clinical research. We aimed to obtain consensus on pediatric clinician- researchers' perceptions of the priorities to feasibly conduct clinical pediatric pandemic research in Europe.Methods: Mixed method study in 2 stages, recruiting pediatric clinicianresearchers with experience of conducting pediatric ID research in clinical settings in Europe. Stage 1 was an expert stakeholder workshop and interviews. Discussions focused on participant's experience of conducting pediatric ID research and processes to facilitate pandemic research. Information informed stage 2, an online consensus survey to identify pediatric inician- researchers priorities to enable ID pandemic research.Results: Twenty-three pediatric clinician-researchers attended the workshop and 39 completed the survey. Priorities were primarily focused on structural and operational requirements of research design and regulation: (1) clarity within the European Clinical Trials Directive for pediatric pandemic research; (2) simplified regulatory processes for research involving clinical samples and data; and (3) improved relationships between regulatory bodies and researchers.Conclusions: Results suggest that changes need to be made to the current regulatory environment to facilitate and improve pediatric research in the pandemic context. These findings can provide expert evidence to research policy decision-makers and regulators and to develop a strategy to lobby for change.",
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author = "Micaela Gal and Nina Gobat and Francis, {Nicholas A.} and Kerenza Hood and Butler, {Christopher C.} and Julia Bielicki and Fraaij, {Pieter L.} and Mike Sharland and Jessica Jarvis and {van Rossum}, {Annemarie M. C.} and Terho Heikkinen and Federico Martinon-Torres and Jethro Herberg and Angela Watkins and Webb, {Steve A. R.} and Ronnie Moore and Prasanth Sukumar and Alistair Nichol",
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Gal, M, Gobat, N, Francis, NA, Hood, K, Butler, CC, Bielicki, J, Fraaij, PL, Sharland, M, Jarvis, J, van Rossum, AMC, Heikkinen, T, Martinon-Torres, F, Herberg, J, Watkins, A, Webb, SAR, Moore, R, Sukumar, P & Nichol, A 2019, 'Priority Needs for Conducting Pandemic-relevant Clinical Research With Children in Europe: A Consensus Study With Pediatric Clinician-researchers' Pediatric Infectious Disease Journal, vol. 38, no. 5, pp. E82-E86. https://doi.org/10.1097/INF.0000000000002204

Priority Needs for Conducting Pandemic-relevant Clinical Research With Children in Europe: A Consensus Study With Pediatric Clinician-researchers. / Gal, Micaela; Gobat, Nina; Francis, Nicholas A.; Hood, Kerenza; Butler, Christopher C.; Bielicki, Julia; Fraaij, Pieter L.; Sharland, Mike; Jarvis, Jessica; van Rossum, Annemarie M. C.; Heikkinen, Terho; Martinon-Torres, Federico; Herberg, Jethro; Watkins, Angela; Webb, Steve A. R.; Moore, Ronnie; Sukumar, Prasanth; Nichol, Alistair.

In: Pediatric Infectious Disease Journal, Vol. 38, No. 5, 05.2019, p. E82-E86.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Priority Needs for Conducting Pandemic-relevant Clinical Research With Children in Europe:

T2 - A Consensus Study With Pediatric Clinician-researchers

AU - Gal, Micaela

AU - Gobat, Nina

AU - Francis, Nicholas A.

AU - Hood, Kerenza

AU - Butler, Christopher C.

AU - Bielicki, Julia

AU - Fraaij, Pieter L.

AU - Sharland, Mike

AU - Jarvis, Jessica

AU - van Rossum, Annemarie M. C.

AU - Heikkinen, Terho

AU - Martinon-Torres, Federico

AU - Herberg, Jethro

AU - Watkins, Angela

AU - Webb, Steve A. R.

AU - Moore, Ronnie

AU - Sukumar, Prasanth

AU - Nichol, Alistair

PY - 2019/5

Y1 - 2019/5

N2 - Background: Infectious disease (ID) pandemics pose a considerable global threat and can disproportionately affect vulnerable populations including children. Pediatric clinical research in pandemics is essential to improve children's healthcare and minimize risks of harm by interventions that lack an adequate evidence base for this population. The unique features of ID pandemics require consideration of special processes to facilitate clinical research. We aimed to obtain consensus on pediatric clinician- researchers' perceptions of the priorities to feasibly conduct clinical pediatric pandemic research in Europe.Methods: Mixed method study in 2 stages, recruiting pediatric clinicianresearchers with experience of conducting pediatric ID research in clinical settings in Europe. Stage 1 was an expert stakeholder workshop and interviews. Discussions focused on participant's experience of conducting pediatric ID research and processes to facilitate pandemic research. Information informed stage 2, an online consensus survey to identify pediatric inician- researchers priorities to enable ID pandemic research.Results: Twenty-three pediatric clinician-researchers attended the workshop and 39 completed the survey. Priorities were primarily focused on structural and operational requirements of research design and regulation: (1) clarity within the European Clinical Trials Directive for pediatric pandemic research; (2) simplified regulatory processes for research involving clinical samples and data; and (3) improved relationships between regulatory bodies and researchers.Conclusions: Results suggest that changes need to be made to the current regulatory environment to facilitate and improve pediatric research in the pandemic context. These findings can provide expert evidence to research policy decision-makers and regulators and to develop a strategy to lobby for change.

AB - Background: Infectious disease (ID) pandemics pose a considerable global threat and can disproportionately affect vulnerable populations including children. Pediatric clinical research in pandemics is essential to improve children's healthcare and minimize risks of harm by interventions that lack an adequate evidence base for this population. The unique features of ID pandemics require consideration of special processes to facilitate clinical research. We aimed to obtain consensus on pediatric clinician- researchers' perceptions of the priorities to feasibly conduct clinical pediatric pandemic research in Europe.Methods: Mixed method study in 2 stages, recruiting pediatric clinicianresearchers with experience of conducting pediatric ID research in clinical settings in Europe. Stage 1 was an expert stakeholder workshop and interviews. Discussions focused on participant's experience of conducting pediatric ID research and processes to facilitate pandemic research. Information informed stage 2, an online consensus survey to identify pediatric inician- researchers priorities to enable ID pandemic research.Results: Twenty-three pediatric clinician-researchers attended the workshop and 39 completed the survey. Priorities were primarily focused on structural and operational requirements of research design and regulation: (1) clarity within the European Clinical Trials Directive for pediatric pandemic research; (2) simplified regulatory processes for research involving clinical samples and data; and (3) improved relationships between regulatory bodies and researchers.Conclusions: Results suggest that changes need to be made to the current regulatory environment to facilitate and improve pediatric research in the pandemic context. These findings can provide expert evidence to research policy decision-makers and regulators and to develop a strategy to lobby for change.

KW - children

KW - infectious disease

KW - outbreak

KW - pandemic research

KW - European Directive

KW - Europe

KW - RANDOMIZED CONTROLLED-TRIALS

KW - INFLUENZA

KW - MEDICINES

KW - INFECTION

KW - LESSONS

U2 - 10.1097/INF.0000000000002204

DO - 10.1097/INF.0000000000002204

M3 - Article

VL - 38

SP - E82-E86

JO - Pediatric Infectious Disease Journal, The

JF - Pediatric Infectious Disease Journal, The

SN - 0891-3668

IS - 5

ER -