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1.
Clin Trials ; 18(5): 615-621, 2021 10.
Article in English | MEDLINE | ID: covidwho-1280563

ABSTRACT

The COVID-19 pandemic has resulted in unprecedented challenges for healthcare systems worldwide. It has also stimulated research in a wide range of areas including rapid diagnostics, novel therapeutics, use of technology to track patients and vaccine development. Here, we describe our experience of rapidly setting up and delivering a novel COVID-19 vaccine trial, using clinical and research staff and facilities in three National Health Service Trusts in Cambridgeshire, United Kingdom. We encountered and overcame a number of challenges including differences in organisational structures, research facilities available, staff experience and skills, information technology and communications infrastructure, and research training and assessment procedures. We overcame these by setting up a project team that included key members from all three organisations that met at least daily by teleconference. This group together worked to identify the best practices and procedures and to harmonise and cascade these to the wider trial team. This enabled us to set up the trial within 25 days and to recruit and vaccinate the participants within a further 23 days. The lessons learned from our experiences could be used to inform the conduct of clinical trials during a future infectious disease pandemic or public health emergency.


Subject(s)
COVID-19 Vaccines/therapeutic use , COVID-19 , Clinical Trials as Topic/standards , Pandemics , COVID-19/prevention & control , Clinical Trials as Topic/organization & administration , Humans , Pandemics/prevention & control , State Medicine , United Kingdom/epidemiology
2.
Br J Psychiatry ; 217(4): 540-542, 2020 10.
Article in English | MEDLINE | ID: covidwho-853428

ABSTRACT

The effects of the COVID-19 pandemic on population mental health are unknown. We need to understand the scale of any such impact in different sections of the population, who is most affected and how best to mitigate, prevent and treat any excess morbidity. We propose a coordinated and interdisciplinary mental health science response.


Subject(s)
Coronavirus Infections , Mental Disorders , Pandemics , Pneumonia, Viral , Preventive Psychiatry/methods , Psychosocial Support Systems , Public Health/methods , Betacoronavirus/pathogenicity , COVID-19 , Coronavirus Infections/epidemiology , Coronavirus Infections/psychology , Coronavirus Infections/therapy , Humans , Mental Disorders/epidemiology , Mental Disorders/prevention & control , Mental Disorders/virology , Mental Health , Mental Health Services/organization & administration , Mental Health Services/standards , Pneumonia, Viral/epidemiology , Pneumonia, Viral/psychology , Pneumonia, Viral/therapy , Quality Improvement , Research Design , Risk Assessment/methods , SARS-CoV-2
4.
Lancet Psychiatry ; 7(6): 547-560, 2020 06.
Article in English | MEDLINE | ID: covidwho-60428

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic is having a profound effect on all aspects of society, including mental health and physical health. We explore the psychological, social, and neuroscientific effects of COVID-19 and set out the immediate priorities and longer-term strategies for mental health science research. These priorities were informed by surveys of the public and an expert panel convened by the UK Academy of Medical Sciences and the mental health research charity, MQ: Transforming Mental Health, in the first weeks of the pandemic in the UK in March, 2020. We urge UK research funding agencies to work with researchers, people with lived experience, and others to establish a high level coordination group to ensure that these research priorities are addressed, and to allow new ones to be identified over time. The need to maintain high-quality research standards is imperative. International collaboration and a global perspective will be beneficial. An immediate priority is collecting high-quality data on the mental health effects of the COVID-19 pandemic across the whole population and vulnerable groups, and on brain function, cognition, and mental health of patients with COVID-19. There is an urgent need for research to address how mental health consequences for vulnerable groups can be mitigated under pandemic conditions, and on the impact of repeated media consumption and health messaging around COVID-19. Discovery, evaluation, and refinement of mechanistically driven interventions to address the psychological, social, and neuroscientific aspects of the pandemic are required. Rising to this challenge will require integration across disciplines and sectors, and should be done together with people with lived experience. New funding will be required to meet these priorities, and it can be efficiently leveraged by the UK's world-leading infrastructure. This Position Paper provides a strategy that may be both adapted for, and integrated with, research efforts in other countries.


Subject(s)
Coronavirus Infections/complications , Coronavirus Infections/psychology , Mental Disorders/complications , Mental Disorders/psychology , Pneumonia, Viral/complications , Pneumonia, Viral/psychology , Research , COVID-19 , Humans , Pandemics
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