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

A Consensus Study With Pediatric Clinician-researchers

Gal, Micaela, DPhil*; Gobat, Nina, PhD*; Francis, Nicholas A., MD*; Hood, Kerenza, PhD; Butler, Christopher C., FRCGP; Bielicki, Julia, MD§; Fraaij, Pieter L., MD; Sharland, Mike, MD§; Jarvis, Jessica, MBBCh§; van Rossum, Annemarie M. C., MD; Heikkinen, Terho, MD**; Martinon-Torres, Federico, MD††; Herberg, Jethro, MD‡‡; Watkins, Angela, BA*; Webb, Steve A. R., MD§§; Moore, Ronnie, PhD¶¶; Sukumar, Prasanth, MPhil¶¶; Nichol, Alistair, MD¶¶,‖‖

The Pediatric Infectious Disease Journal: May 2019 - Volume 38 - Issue 5 - p e82–e86
doi: 10.1097/INF.0000000000002204
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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 clinician-researchers 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.

From the *School of Medicine

Centre for Trials Research, Cardiff University, Cardiff, United Kingdom

Nuffield Department of Primary Health, University of Oxford, Oxford, United Kingdom

§Paediatric Infectious Diseases Research Group, St George’s University of London, London, United Kingdom

Department of Virology, Erasmus Medical Centre-Sophia, Rotterdam, The Netherlands

Department of Paediatric Infectious Diseases, Immunology and Rheumatology, Erasmus Medical Centre, Rotterdam, The Netherlands

**Department of Paediatrics, University of Turku and Turku University Hospital, Turku, Finland

††Translational Paediatrics and Infectious Diseases, Hospital Cliínico Universitario de Santiago, Santiago de Compostela, Spain

‡‡Department of Medicine, Imperial College London, London, United Kingdom

§§University of Western Australia, Perth, Western Australia, Australia

¶¶School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland

‖‖School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.

Accepted for publication August 30, 2018.

The authors have no conflicts of interest to disclose.

M.G. drafted the article, and all authors provided critical review, edited and approved the final article. M.G., N.A.F., C.C.B. and A.N. were involved in the funding application for the study. M.G. and N.G. co-led on study design and implementation, ethics approvals, participant recruitment and analysis of workshop and interview data. M.G. led analysis of the survey data and is guarantor. M.G., N.G., N.A.F., K.H., C.C.B., J.B., P.L.F., M.S., R.M., P.S. and A.N. conceived the study idea. A.W. administered the study, designed the survey tool and curated the survey data. All authors contributed to study design and interpretation.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (www.pidj.com).

Address for correspondence: Micaela Gal, Neuadd Meirionnydd, Division of Population Medicine, School of Medicine, Cardiff University, Heath Park, Cardiff, CF14 4YS, United Kingdom. E-mail: galm@cardiff.ac.uk.Supported by the European Union Seventh Framework Programme under the project “Platform foR European Preparedness Against (Re-) emerging Epidemics,” (grant agreement 602525).

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