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1.
BMJ Open ; 10(10): e044566, 2020 10 05.
Artigo em Inglês | MEDLINE | ID: mdl-33020111

RESUMO

OBJECTIVES: To analyse enrolment to interventional trials during the first wave of the COVID-19 pandemic in England and describe the barriers to successful recruitment in the circumstance of a further wave or future pandemics. DESIGN: We analysed registered interventional COVID-19 trial data and concurrently did a prospective observational study of hospitalised patients with COVID-19 who were being assessed for eligibility to one of the RECOVERY, C19-ACS or SIMPLE trials. SETTING: Interventional COVID-19 trial data were analysed from the clinicaltrials.gov and International Standard Randomized Controlled Trial Number databases on 12 July 2020. The patient cohort was taken from five centres in a respiratory National Institute for Health Research network. Population and modelling data were taken from published reports from the UK government and Medical Research Council Biostatistics Unit. PARTICIPANTS: 2082 consecutive admitted patients with laboratory-confirmed SARS-CoV-2 infection from 27 March 2020 were included. MAIN OUTCOME MEASURES: Proportions enrolled, and reasons for exclusion from the aforementioned trials. Comparisons of trial recruitment targets with estimated feasible recruitment numbers. RESULTS: Analysis of trial registration data for COVID-19 treatment studies enrolling in England showed that by 12 July 2020, 29 142 participants were needed. In the observational study, 430 (20.7%) proceeded to randomisation. 82 (3.9%) declined participation, 699 (33.6%) were excluded on clinical grounds, 363 (17.4%) were medically fit for discharge and 153 (7.3%) were receiving palliative care. With 111 037 people hospitalised with COVID-19 in England by 12 July 2020, we determine that 22 985 people were potentially suitable for trial enrolment. We estimate a UK hospitalisation rate of 2.38%, and that another 1.25 million infections would be required to meet recruitment targets of ongoing trials. CONCLUSIONS: Feasible recruitment rates, study design and proliferation of trials can limit the number, and size, that will successfully complete recruitment. We consider that fewer, more appropriately designed trials, prioritising cooperation between centres would maximise productivity in a further wave.


Assuntos
Pesquisa Biomédica , Infecções por Coronavirus , Pandemias , Seleção de Pacientes , Pneumonia Viral , Ensaios Clínicos Controlados Aleatórios como Assunto , Betacoronavirus/isolamento & purificação , Pesquisa Biomédica/organização & administração , Pesquisa Biomédica/estatística & dados numéricos , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Definição da Elegibilidade , Feminino , Acesso aos Serviços de Saúde/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Sistema de Registros/estatística & dados numéricos , Reino Unido
2.
Recenti Prog Med ; 111(9): 487-491, 2020 09.
Artigo em Italiano | MEDLINE | ID: mdl-32914776

RESUMO

CoViD-19 pandemic heavily impacted most on-going research activities, causing delays and need of re-programming. EASY-NET (NET-2016-02364191) is a network project, started in April 2019, co-funded by the Italian Ministry of Health and the participating regions. Within the general project, centred on the evaluation of Audit and Feedback (A&F) strategies in improving quality and equity in different health care contexts, the Piedmont region is responsible of the work package 3 (WP3) on specific oncology pathways and procedures. After a thorough evaluation of the impact of the CoViD-19 emergency on the WP3 activities, at the beginning of March 2020, the decision was to continue, with some adaptations, the audits already started, and to delay those in the early planning phase. The provisional availability of part of the time-persons involved in EASY-NET on one side, and the urgency of acquiring data on the management of the large number of CoViD-19 patients admitted to the study coordinator hospital on the other side, determined the personnel responsible of the WP3, in accordance with the hospital management, to invest these resources in monitoring the CoViD-19 hospitalized patients with both A&F activity and research objectives. Besides periodic reports, a web site, with restricted access to the involved health care personnel, was developed to allow a direct and timely consultation of graphics describing the flow of the patients, their management, and outcomes. This experience was made possible thanks to a favourable combination of different factors: the presence within the hospital of a group of experienced epidemiologists in A&F, the availability of extra resources, the strong support and collaboration by the hospital management and the readiness for authorisation by the Ethics Committee. We underline the need to provide a certain degree of flexibility in the long-term projects funded by the Ministry of Health, the extraordinary adaptability of the A&F approach also to emergency situations and the possibility of combining audit activities and research objectives in the same project.


Assuntos
Infecções por Coronavirus/epidemiologia , Assistência à Saúde/organização & administração , Hospitalização/estatística & dados numéricos , Auditoria Médica/organização & administração , Pneumonia Viral/epidemiologia , Pesquisa Biomédica/organização & administração , Assistência à Saúde/normas , Humanos , Itália/epidemiologia , Pandemias , Qualidade da Assistência à Saúde
3.
West J Emerg Med ; 21(5): 1114-1117, 2020 Jul 21.
Artigo em Inglês | MEDLINE | ID: mdl-32970563

RESUMO

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic has seriously impacted clinical research operations in academic medical centers due to social distancing measures and stay-at-home orders. The purpose of this paper is to describe the implementation of a program to continue clinical research based out of an emergency department (ED) using remote research associates (RA). METHODS: Remote RAs were trained and granted remote access to the electronic health record (EHR) by the health system's core information technology team. Upon gaining access, remote RAs used a dual-authentication process to gain access to a host-based, firewall-protected virtual network where the EHR could be accessed to continue screening and enrollment for ongoing studies. Study training for screening and enrollment was also provided to ensure study continuity. RESULTS: With constant support and guidance available to establish this EHR access pathway, the remote RAs were able to gain access relatively independently and without major technical troubleshooting. Each remote RA was granted access and trained on studies within one week and self-reported a high degree of program satisfaction, EHR access ease, and study protocol comfort through informal evaluation surveys. CONCLUSIONS: In response to the COVID-19 pandemic, we virtualized a clinical research program to continue important ED-based studies.


Assuntos
Betacoronavirus , Pesquisa Biomédica/organização & administração , Infecções por Coronavirus/prevenção & controle , Registros Eletrônicos de Saúde , Serviço Hospitalar de Emergência/organização & administração , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Pesquisadores/organização & administração , Centros Médicos Acadêmicos/organização & administração , California , Humanos , Informática Médica , Desenvolvimento de Programas
4.
Clin Invest Med ; 43(3): E1-4, 2020 09 24.
Artigo em Inglês | MEDLINE | ID: mdl-32971578

RESUMO

Message from the CITAC president To say that 2020 has been an unprecedented year is an understatement. The coronavirus disease 2019 (COVID-19) global pandemic and the major societal awakening on racial equity and justice have led us to reflect on our direction, goals and mission. Thanks to our talented and dedicated executive team, we were able to pivot our efforts and adapt to the changing landscape of research and advocacy. In April, we provided our members with a list of resources to help facilitate a smooth transition to working from home. In June, we published Clinician Investigator Trainee Association of Canada's (CITAC) press release on our role in combating anti-Black discrimination and racial injustice and have outlined specific advocacy efforts that we will be committing to over the next years (the full statement can be found on our website, https://www.citac-accfc.org).


Assuntos
Pesquisa Biomédica/organização & administração , Pesquisadores , Justiça Social , Betacoronavirus , Pesquisa Biomédica/tendências , Canadá , Infecções por Coronavirus/epidemiologia , Humanos , Pandemias , Pneumonia Viral/epidemiologia , Apoio ao Desenvolvimento de Recursos Humanos
8.
Crit Care Med ; 48(10): 1403-1410, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32796181

RESUMO

OBJECTIVES: To describe the importance of critical care clinical research that is not pandemic-focused during pandemic times; outline principles to assist in the prioritization of nonpandemic research during pandemic times; and propose a guiding framework for decisions about whether, when and how to continue nonpandemic research while still honoring the moral and scientific imperative to launch research that is pandemic-focused. DESIGN/DATA SOURCES: Using in-person, email, and videoconference exchanges, we convened an interprofessional clinical research group, conducted a literature review of empirical studies, ethics documents and expert commentaries (2010 to present), and viewed traditional and social media posts (March 2020 to May 2020). Stakeholder consultation involved scientific, ethics, clinical, and administrative leaders. SETTING: Clinical research in the ICU. PATIENTS: Patients with and without coronavirus disease 2019. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: While clinical research should be prioritized to advantage patients with coronavirus disease 2019 in order to care for affected patients, it ideally would not unduly disadvantage patients without coronavirus disease 2019. Thus, timely, rigorous, relevant, and ethical clinical research is needed to improve the care and optimize outcomes for both patients with and without coronavirus disease 2019, acknowledging how many studies that are not exclusively focused on coronavirus disease 2019 remain relevant to patients with coronavirus disease 2019. Considerations to continue nonpandemic-focused research include the status of the pandemic, local jurisdictional guidance, capacity and safety of bedside and research personnel, disposition of patients already enrolled in nonpandemic studies, analyzing characteristics of each nonpandemic-focused study, research oversight, and final reporting requirements. CONCLUSIONS: Deliberation about continuing nonpandemic research should use objective, transparent criteria considering several aspects of the research process such as bedside and research staff safety, infection control, the informed consent model, protocol complexity, data collection, and implementation integrity. Decisions to pause or pursue nonpandemic research should be proportionate, transparent, and revisited as the pandemic abates.


Assuntos
Pesquisa Biomédica/organização & administração , Infecções por Coronavirus/epidemiologia , Cuidados Críticos/normas , Pandemias/estatística & dados numéricos , Pneumonia Viral/epidemiologia , Guias de Prática Clínica como Assunto , Infecções por Coronavirus/prevenção & controle , Estado Terminal/mortalidade , Estado Terminal/terapia , Feminino , Saúde Global , Humanos , Controle de Infecções/normas , Masculino , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Projetos de Pesquisa , Gestão da Segurança
9.
PLoS Biol ; 18(8): e3000889, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32853196

RESUMO

The SARS-CoV-2 epidemic challenged universities and other academic institutions to rapidly adapt to urgent and life-threatening situations. It forced most institutions to shut down nearly every aspect of their research and educational enterprises. In doing so, university leaders were thrust into unchartered waters and forced them to make unprecedented decisions. Successes and failures along the way highlighted how the autonomous nature of the American academic research enterprise and skillsets normally required of university leaders were ill-suited to mounting an emergency response. Here, as faculty from medical centers in the United States, we draw lessons from these experiences and apply them as we plan for the next possible COVID-19-induced shutdown as well as other large-scale pandemics and emergencies at universities in the United States and throughout the world.


Assuntos
Betacoronavirus/patogenicidade , Pesquisa Biomédica/organização & administração , Defesa Civil/organização & administração , Infecções por Coronavirus/epidemiologia , Pandemias , Pneumonia Viral/epidemiologia , Humanos , Guias de Prática Clínica como Assunto , Saúde Pública , Estados Unidos/epidemiologia , Universidades
10.
Trends Biochem Sci ; 45(10): 823-825, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32792175

RESUMO

The interplay between academics and society within the environment of the COVID-19 pandemic has impacted on scientists across the world, prompting reevaluation of how virtual toolboxes can be used to support responsible collaborative research practices. We provide awareness of virtual resources and activities that enable scientific discovery using safe and efficient practices.


Assuntos
Pesquisa Biomédica/organização & administração , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/psicologia , Práticas Interdisciplinares/organização & administração , Pandemias , Pneumonia Viral/epidemiologia , Pneumonia Viral/psicologia , Interface Usuário-Computador , Betacoronavirus/patogenicidade , Infecções por Coronavirus/transmissão , Infecções por Coronavirus/virologia , Humanos , Disseminação de Informação , Pneumonia Viral/transmissão , Pneumonia Viral/virologia , Saúde Pública , Distância Social , Mídias Sociais
12.
Value Health ; 23(8): 1072-1078, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32828220

RESUMO

Although it is generally accepted that human tissue biobanks are important to facilitate progress in health and medical research, many academic biobanks face sustainability challenges. We propose that biobank sustainability is challenged by a lack of available data describing the outputs and benefits that are produced by biobanks, as reflected by a dearth of publications that enumerate biobank outputs. We further propose that boosting the available information on biobank outputs and using a broader range of output metrics will permit economic analyses such as cost-consequence analyses of biobank activity. Output metrics and cost-consequence analyses can allow biobanks to achieve efficiencies, and improve the quality and/or quantity of their outputs. In turn, biobank output measures provide all stakeholders with explicit and accountable data on biobank value, which could contribute to the evolution of biobank operations to best match research needs, and mitigate some threats to biobank sustainability.


Assuntos
Bancos de Espécimes Biológicos/organização & administração , Pesquisa Biomédica/organização & administração , Modelos Econométricos , Bancos de Espécimes Biológicos/economia , Pesquisa Biomédica/economia , Custos e Análise de Custo , Humanos
13.
PLoS One ; 15(8): e0238071, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32857794

RESUMO

This study delineates the relative importance of organisational, research discipline and application domain factors in influencing researchers' data sharing practices in Australia's national scientific and industrial research agency. We surveyed 354 researchers and found that the number of data deposits made by researchers were related to the openness of the data culture and the contractual inhibitors experienced by researchers. Multi-level modelling revealed that organisational unit membership explained 10%, disciplinary membership explained 6%, and domain membership explained 4% of the variance in researchers' intentions to share research data. However, only the organisational measure of openness to data sharing explained significant unique variance in data sharing. Thus, whereas previous research has tended to focus on disciplinary influences on data sharing, this study suggests that factors operating within the organisation have the most powerful influence on researchers' data sharing practices. The research received approval from the organisation's Human Research Ethics Committee (no. 014/18).


Assuntos
Disseminação de Informação , Pesquisadores/psicologia , Adulto , Idoso , Austrália , Pesquisa Biomédica/organização & administração , Comportamento Cooperativo , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Adulto Jovem
14.
Surg Endosc ; 34(10): 4225-4232, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32749615

RESUMO

BACKGROUND: Healthcare systems and general surgeons are being challenged by the current pandemic. The European Association for Endoscopic Surgery (EAES) aimed to evaluate surgeons' experiences and perspectives, to identify gaps in knowledge, to record shortcomings in resources and to register research priorities. METHODS: An ad hoc web-based survey of EAES members and affiliates was developed by the EAES Research Committee. The questionnaire consisted of 69 items divided into the following sections: (Ι) demographics, (II) institutional burdens and management strategies, and (III) analysis of resource, knowledge, and evidence gaps. Descriptive statistics were summarized as frequencies, medians, ranges,, and interquartile ranges, as appropriate. RESULTS: The survey took place between March 25th and April 16th with a total of 550 surgeons from 79 countries. Eighty-one percent had to postpone elective cases or suspend their practice and 35% assumed roles not related to their primary expertise. One-fourth of respondents reported having encountered abdominal pathologies in COVID-19-positive patients, most frequently acute appendicitis (47% of respondents). The effect of protective measures in surgical or endoscopic procedures on infected patients, the effect of endoscopic surgery on infected patients, and the infectivity of positive patients undergoing laparoscopic surgery were prioritized as knowledge gaps and research priorities. CONCLUSIONS: Perspectives and priorities of EAES members in the era of the pandemic are hereto summarized. Research evidence is urgently needed to effectively respond to challenges arisen from the pandemic.


Assuntos
Betacoronavirus , Pesquisa Biomédica , Infecções por Coronavirus , Endoscopia , Pandemias , Pneumonia Viral , Pesquisa Biomédica/métodos , Pesquisa Biomédica/organização & administração , Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/transmissão , Europa (Continente) , Alocação de Recursos para a Atenção à Saúde/métodos , Alocação de Recursos para a Atenção à Saúde/estatística & dados numéricos , Humanos , Controle de Infecções/métodos , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Pneumonia Viral/transmissão , Padrões de Prática Médica/tendências , Sociedades Médicas , Cirurgiões , Inquéritos e Questionários
16.
BMJ Glob Health ; 5(7)2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32727843

RESUMO

INTRODUCTION: In March 2020, the WHO released a Global Research Roadmap in an effort to coordinate and accelerate the global research response to combat COVID-19 based on deliberations of 400 experts across the world. Three months on, the disease and our understanding have both evolved significantly. As we now tackle a pandemic in very different contexts and with increased knowledge, we sought to build on the work of the WHO to gain a more current and global perspective on these initial priorities. METHODS: We undertook a mixed methods study seeking the views of the global research community to (1) assess which of the early WHO roadmap priorities are still most pressing; (2) understand whether they are still valid in different settings, regions or countries; and (3) identify any new emerging priorities. RESULTS: Thematic analysis of the significant body of combined data shows the WHO roadmap is globally relevant; however, new important priorities have emerged, in particular, pertinent to low and lower middle-income countries (less resourced countries), where health systems are under significant competing pressures. We also found a shift from prioritising vaccine and therapeutic development towards a focus on assessing the effectiveness, risks, benefits and trust in the variety of public health interventions and measures. Our findings also provide insight into temporal nature of these research priorities, highlighting the urgency of research that can only be undertaken within the period of virus transmission, as well as other important research questions but which can be answered outside the transmission period. Both types of studies are key to help combat this pandemic but also importantly to ensure we are better prepared for the future. CONCLUSION: We hope these findings will help guide decision-making across the broad research system including the multilateral partners, research funders, public health practitioners, clinicians and civil society.


Assuntos
Pesquisa Biomédica , Infecções por Coronavirus , Saúde Global , Pandemias , Pneumonia Viral , Pesquisa , Betacoronavirus , Pesquisa Biomédica/métodos , Pesquisa Biomédica/organização & administração , Pesquisa Biomédica/normas , Humanos
19.
F1000Res ; 9: 583, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32595962

RESUMO

Background:  TDR, The Special Programme for Research and Training hosted at the World Health Organization, has long supported Low- and Middle-Income Countries in strengthening research capacity through three training programmes: the Postgraduate Training Scheme (PGTS), the Clinical Research and Development Fellowship (CRDF), and the Structured Operational Research Training InitiaTive (SORT IT). In the advent of the COVID-19 pandemic, we assessed whether those trained through these programmes were involved in the COVID-19 response and if so, in which area(s) of the emergency response they were applying their skills. Methods: From the records for each training programme, we identified the individuals who had completed training during the relevant timespan of each programme: 1999-2018 for the CRDF scheme, 2015-2020 for PGTS, and 2009-2019 for SORT-IT. Between March and April 2020, we sent trainees an online questionnaire by e-mail. Results: Out of 1254 trained, 1143 could be contacted and 699 responded to the survey. Of the latter, 411 were involved with the COVID-19 response, of whom 315 (77%) were applying their acquired skills in 85 countries. With some overlap between programmes, 84% of those trained through CRDF were applying their skills in 27 countries, 91% of those trained through PGTS were applying their skills in 19 countries, and through SORT IT, this was 73% in 62 countries.  Skills were being applied in various areas of the emergency response, including: emergency preparedness, situation analysis/surveillance, infection control and clinical management, data generation, mitigating the effect of COVID on the health system, and research.  Depending on the type of training programme, 26-74% were involved in implementation, operational or clinical research. Conclusion: Research training programmes build research capacity and equip health workers with transferable core competencies and skillsets prior to epidemics. This becomes invaluable in building health system resilience at a time of pandemics.


Assuntos
Pesquisa Biomédica/organização & administração , Infecções por Coronavirus , Pandemias , Pneumonia Viral , Avaliação de Programas e Projetos de Saúde , Betacoronavirus , Estudos Transversais , Educação Continuada/organização & administração , Bolsas de Estudo , Humanos , Inquéritos e Questionários
20.
Vaccine ; 38(34): 5418-5423, 2020 07 22.
Artigo em Inglês | MEDLINE | ID: mdl-32600908

RESUMO

The World Health Organization declared the COVID-19 disease as a pandemic requiring a rapid response. Through online search, direct communication with network members and an internal survey, engagements of developing countries' vaccine manufacturers' network members in the research and development of COVID-19 vaccines and their capacities in the manufacturing, fill-finish and distribution of vaccines were assessed. Currently, 19 network members engaged in research and development of COVID-19 vaccines, using six principal technology platforms. In addition, an internal survey showed that the number of vaccines supplied collectively by 37 members, in 2018-19, was about 3.5 billion doses annually. Almost a third of network members having vaccines prequalified by the World Health Organization comply with international regulations and mechanisms to distribute vaccines across borders. The use of existing manufacturing, fill-finish and distribution capabilities can support an efficient roll-out of vaccines against COVID-19, while maintaining supply security of existing vaccines for on-going immunization programmes.


Assuntos
Pesquisa Biomédica/organização & administração , Infecções por Coronavirus , Indústria Farmacêutica/organização & administração , Cooperação Internacional , Pandemias , Pneumonia Viral , Vacinas Virais/provisão & distribução , Ensaios Clínicos como Assunto , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/prevenção & controle , Humanos , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Vacinas Virais/imunologia , Organização Mundial da Saúde
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