Literature DB >> 35218745

COVID-19 kick-starts a new era for clinical trials and pandemic preparedness in Europe.

Evelyn Depoortere1, Stefanie Sowinski2, Arjon van Hengel2, Barbara Kerstiëns2, Irene Norstedt2.   

Abstract

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Year:  2022        PMID: 35218745      PMCID: PMC8865874          DOI: 10.1016/S1473-3099(22)00059-7

Source DB:  PubMed          Journal:  Lancet Infect Dis        ISSN: 1473-3099            Impact factor:   25.071


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In their Personal View on the European clinical research response to COVID-19, Herman Goossens and colleagues provide relevant recommendations for a future perspective for the pandemic research response. As a European public funder, we add complementary views below. To address research questions posed by infectious disease threats more swiftly, the European Commission developed specific provisions in its annual work programmes for health research, allowing for mobilisation of research funds in case of public health emergencies. The first such call in response to the COVID-19 pandemic—guaranteeing fair competition for the award of public funds—was made on Jan 30, 2020. Because researchers were given no more than 13 days to prepare proposals, they were allowed to be less elaborate than usually expected under Horizon 2020 rules. These challenging timelines reflect the urgency of the pandemic response. Project costs were eligible for reimbursement as of Feb 13, 2020. Grant agreements included dedicated provisions for open access to research data, in line with Horizon 2020 provisions for grants awarded in public health emergencies. The ERAvsCORONA action plan committed to support large EU-wide clinical trials for clinical management of patients with COVID-19. Therefore, Horizon 2020 funds were rapidly mobilised to increase funding for the REMAP-CAP trial, and two additional trials were funded through the EU-RESPONSE project. This enabled the European expansion of the French-initiated DisCoVeRy trial and the establishment of a new platform trial, EU-SolidAct. Coordination of trials is essential and targeted mechanisms were successfully established for this purpose. The trial coordination board facilitates structural dialogue between coordinators of EU-funded and other adaptive platform trials to ensure cooperation and synergy. The joint access advisory mechanism ensures scientific assessment of candidate treatments with regard to their suitability for these EU-funded trials. Efforts are being made to overcome the hurdles encountered during the COVID-19 pandemic for the swift implementation of large-scale clinical trials of complex design across multiple countries. It is hoped that this will improve preparedness for both future epidemic or pandemic waves of COVID-19 and other diseases. The COVID-19 pandemic has opened significant opportunities for strengthened preparedness in Europe and beyond. Synergies between COVID-19 pandemic response initiatives and others—such as Ecraid—need to be sought. Solutions are needed to enable complex and multicountry adaptive platform trials and to expedite their implementation or reorientation across the globe. Successful initiatives should be anchored sustainably in Europe's future pandemic preparedness. The European Health Emergency Response Authority and the European Research and Innovation Partnership for Pandemic Preparedness are intended to provide the suitable framework for this purpose for Europe, while remaining open to the world, including through other partnerships. We declare no competing interests.
  2 in total

1.  Re: Accelerating clinical trial implementation in the context of the COVID-19 pandemic by Diallo et al.

Authors:  Andrzej Rys; Irene Norstedt
Journal:  Clin Microbiol Infect       Date:  2022-01-25       Impact factor: 8.067

Review 2.  The European clinical research response to optimise treatment of patients with COVID-19: lessons learned, future perspective, and recommendations.

Authors:  Herman Goossens; Lennie Derde; Peter Horby; Marc Bonten
Journal:  Lancet Infect Dis       Date:  2021-12-21       Impact factor: 71.421

  2 in total

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