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      Harmonisation preserves research resources

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          Abstract

          In their Comment, the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) clinical characterisation group outline how harmonisation of clinical characterisation studies is achieved through their collaborative resource-sharing and data-sharing platform. 1 We fully agree with both the importance of international harmonisation and the authors' approach. Yet, in our opinion, they could have expressed more clearly how important harmonisation is to use resources in research responsibly and efficiently. ISARIC contributors in Germany face the dilemma of having multiple national and international clinical registers for patients with COVID-19. For example, in addition to ISARIC, the University Hospital Düsseldorf enters patient information into the Lean European Open Survey on SARS-CoV-2 Infected Patients (LEOSS) register, 2 which as of July 8, 2020, contains data from 3048 patients (most are from Germany, but the aim is for international contributions), and national registers of German academic societies (German Society for Pediatric Infectious Diseases [DGPI] 3 and German Interdisciplinary Association for Intensive Care and Emergency Medicine, where daily data contribution to the latter has become mandatory). Consequently, time needed for data capture and entry by clinical and research staff is multiplied and records are entered with substantial delay. Although negotiations on harmonisation started internally at the hospital in early February, and were extended to some register providers, different emphases of the registers and concerns about feasibility of some aspects of ISARIC data provision resulted in the current situation. Importantly, LEOSS providers were concerned about pseudonymised collection of data, which might have necessitated individual informed consent from patients, 2 and the DGPI register providers expected ISARIC forms to be too extensive to facilitate widespread participation by clinicians. Ultimately, under strict conditions, some German ethics committees waived the need for individual consent for collection of pseudonymised clinical data, and the time needed for completion of ISARIC core forms and data entry is less than 30 min per case. Another European example shows that early communication and cooperation between study leads can produce a more efficient setup. Facilitated through the Penta ID Network of paediatric infectious diseases researchers, in the first week of February, ISARIC shared their data specification with the Spanish paediatric register for COVID-19 patients (EPICO), 4 which then integrated several items into its case report forms. Currently, EPICO is continuing to harmonise its register with further data capture tools from WHO and other cohorts. In this way, data from several registers can be combined at any point in time and physicians do not waste time with multiple data entries. We feel this is an important learning point: harmonisation can best be achieved by reaching out to scientific societies and eminent researchers at the earliest time possible, and by open sharing of resources without claiming ownership of the generated results.

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          Screening and Severity of Coronavirus Disease 2019 (COVID-19) in Children in Madrid, Spain

          This case series describes the testing for and treatment of children with coronavirus disease 2019 (COVID-19) in Madrid, Spain.
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            Hospital Admission in Children and Adolescents With COVID-19.

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              Global outbreak research: harmony not hegemony

              To make clinical and biological observations within a timeframe that is likely to benefit patients during disease outbreaks, coordination of global research must match the speed of spread of novel pathogens. Time is short. Circumstances call for international collaboration to understand, treat, and prevent coronavirus disease 2019 (COVID-19). During previous infectious disease outbreaks, clinical research has often been established on an ad-hoc basis and done in silos, using different methodologies and designs. This approach limits opportunities to compare results, or to combine smaller studies to obtain answers quickly. Thus, perhaps it is self-evident that harmonisation of clinical investigation during outbreaks is desirable. In a meeting of the WHO clinical management research prioritisation group held in January, 2020, harmonised clinical characterisation research was identified as the first priority for COVID-19. Harmonisation creates opportunities for individual investigators to compare results or collaborate, without applying burdens or obligations. In our experience, the quality and breadth of research is improved by collaborative development and peer review of shared protocols. For example, in the current outbreak, a clinician might design a study to identify risk factors for progression, co-infections, and mechanisms of critical illness. However, clinicians might overlook the need to obtain serum for research groups with the capability to make new assays for seroepidemiology, or peripheral blood mononuclear cells for monoclonal antibody therapeutics during this process. Wide collaboration leads to better, faster science. Achieving global coordination is difficult enough at the best of times; during a crisis it might seem impossible. But with each new crisis, the same questions arise again and again, and so, the same designs can be used to tackle them. We believe that global harmonisation is possible, at least in the intermittently indispensable field of outbreak research. To achieve such a goal, harmonised investigation needs to be made easier than establishing isolated independent studies, must respect autonomy and sovereignty of investigators, and relinquish normal routes of academic recognition for this work. To this end, in 2012, a single, standardised generic research protocol was created for clinical characterisation of any emerging infection (the International Severe Acute Respiratory and Emerging Infection Consortium [ISARIC]/WHO Clinical Characterisation Protocol [CCP]), which was the result of many years of international and cross-speciality consensus-building. 1 Since the fundamental research questions in a new outbreak are predictable, the protocol can be established and approved in so-called peacetime, maintained in a hibernating state, then rapidly implemented when required. Carefully designed, flexible biological sampling schedules are included in tiers according to local resources, modular additional studies for specific situations, and scalable case report forms. 1 These tools were released under an open-source licence—ie, anyone can download these materials and use, adapt, or distribute them. Clinical research can feel like it is 95% about filling in forms. We filled in some of the forms, so you don't have to. In 2016, the ISARIC/WHO CCP was implemented in Brazil in response to the emergence of Zika virus and chikungunya virus in Latin America, facilitating studies of viral shedding and serology. 2 The CCP was also used for the establishment of cohort studies of critically ill patients with Middle East respiratory syndrome. 3 At present, the Uganda Virus Research Institute (Entebbe, Uganda) is using the protocol to study severe acute febrile illness and severe influenza. 4 The value of this approach is becoming apparent in the age of COVID-19. The original reports on clinical findings in COVID-19 used harmonised data collection.5, 6 46 countries have registered to record clinical data using the ISARIC/WHO CCP Case Report Form and investigators in many countries are planning to use the CCP biological sampling protocol to coordinate studies of transmission, prognostication, pathogenesis, and diagnostics (appendix). Understanding the genetic mechanisms underlying susceptibility 7 might directly advance our understanding of disease mechanisms 8 and possible treatments, 9 but robust studies require recruitment of large numbers of critically ill patients, which requires open, collegiate, and global collaboration. Genetics Of Mortality In Critical Care is an open consortium in which clinicians have been recruiting critically ill patients since 2016. Importantly, this work is led by the clinicians treating the patients, in collaboration with experts in host genetics. Operating clinical trials at global scale presents many additional challenges, but even in this domain, substantial progress has been made. Before the COVID-19 pandemic, the critical care community created a highly efficient, randomised, embedded multifactorial adaptive platform trial for community-acquired pneumonia (REMAP-CAP). This single trial was established in 13 countries with the capacity to test new hypotheses quickly. Perhaps most ambitious of all, WHO has developed a global platform—the SOLIDARITY trial 10 —for the evaluation of widely-available interventions to treat COVID-19. Catastrophes, such as pandemics, drive innovation and lead to marked social change. Within the scientific research community, we believe that perceptions of academic excellence have long undervalued teamwork and collegiality. We hope our colleagues across the world will make use of these tools, either in collaboration or independently, to harmonise clinical research efforts and fulfil the duties of medical science to humanity in the shortest time possible.
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                Author and article information

                Contributors
                Journal
                Lancet Infect Dis
                Lancet Infect Dis
                The Lancet. Infectious Diseases
                Elsevier Ltd.
                1473-3099
                1474-4457
                24 July 2020
                24 July 2020
                Affiliations
                [a ]Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's University of London, London, UK
                [b ]Institute for Medical Microbiology and Hospital Hygiene, Heinrich Heine University Düsseldorf, 40225 Düsseldorf, Germany
                [c ]Paediatric Infectious Diseases Unit, Department of Paediatrics, Hospital Universitario 12 de Octubre, Madrid, Spain
                [d ]Paediatric Research and Clinical Trials Unit, Instituto de Investigación Sanitaria Hospital 12 de Octubre and Translational Research Network in Paediatric Infectious Diseases, Fundación para la Investigación Biomédica del Hospital 12 de Octubre, Madrid, Spain
                [e ]Department of Paediatric Cardiology, Pulmonology and Intensive Care Medicine, University Children's Hospital Tübingen, Tübingen, Germany
                [f ]Paediatrics Department, Hospital Universitario Infanta Sofía, Paediatrics Research Group, Universidad Europea de Madrid, Madrid, Spain
                [g ]Department of Infectious Diseases and Vaccinology, University of Basel Children's Hospital, Basel, Switzerland
                [h ]Fondazione Penta Onlus, Padova, Italy
                Article
                S1473-3099(20)30585-5
                10.1016/S1473-3099(20)30585-5
                7380932
                © 2020 Elsevier Ltd. All rights reserved.

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

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                Infectious disease & Microbiology

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