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5.
Lancet Infect Dis ; 21(8): e222-e233, 2021 08.
Article in English | MEDLINE | ID: covidwho-1595466

ABSTRACT

For the past 20 years, the notion of bioterror has been a source of considerable fear and panic worldwide. In response to the terror attacks of 2001 in the USA, extensive research funding was awarded to investigate bioterror-related pathogens. The global scientific legacy of this funding has extended into the present day, highlighted by the ongoing COVID-19 pandemic. Unsurprisingly, the surge in biodefence-related research and preparedness has been met with considerable apprehension and opposition. Here, we briefly outline the history of modern bioterror threats and biodefence research, describe the scientific legacy of biodefence research by highlighting advances pertaining to specific bacterial and viral pathogens, and summarise the future of biodefence research and its relevance today. We sought to address the sizeable question: have the past 20 years of investment into biodefence research and preparedness been worth it? The legacy of modern biodefence funding includes advancements in biosecurity, biosurveillence, diagnostics, medical countermeasures, and vaccines. In summary, we feel that these advances justify the substantial biodefence funding trend of the past two decades and set a precedent for future funding.


Subject(s)
Biomedical Research/economics , Bioterrorism/prevention & control , Financial Support , Humans , Investments , Risk Assessment , Vaccines/immunology
6.
BMJ ; 375: n3109, 2021 12 17.
Article in English | MEDLINE | ID: covidwho-1592685
7.
J Int AIDS Soc ; 24(12): e25846, 2021 12.
Article in English | MEDLINE | ID: covidwho-1591262

ABSTRACT

INTRODUCTION: While pregnant people have been an important focus for HIV research, critical evidence gaps remain regarding prevention, co-infection, and safety and efficacy of new antiretroviral therapies in pregnancy. Such gaps can result in harm: without safety data, drugs used may carry unacceptable risks to the foetus or pregnant person; without pregnancy-specific dosing data, pregnant people face risks of both toxicity and undertreatment; and delays in gathering evidence can limit access to beneficial next-generation drugs. Despite recognition of the need, numerous barriers and ethical complexities have limited progress. We describe the process, ethical foundations, recommendations and applications of guidance for advancing responsible inclusion of pregnant people in HIV/co-infections research. DISCUSSION: The 26-member international and interdisciplinary Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) Working Group was convened to develop ethics-centred guidance for advancing timely, responsible HIV/co-infections research with pregnant people. Deliberations over 3 years drew on extensive qualitative research, stakeholder engagement, expert consultation and a series of workshops. The guidance, initially issued in July 2020, highlights conceptual shifts needed in framing research with pregnant people, and articulates three ethical foundations to ground recommendations: equitable protection from drug-related risks, timely access to biomedical advances and equitable respect for pregnant people's health interests. The guidance advances 12 specific recommendations, actionable within the current regulatory environment, addressing multiple stakeholders across drug development and post-approval research, and organized around four themes: building capacity, supporting inclusion, achieving priority research and ensuring respect. The recommendations describe strategies towards ethically redressing the evidence gap for pregnant people around HIV and co-infections. The guidance has informed key efforts of leading organizations working to advance needed research, and identifies further opportunities for impact by a range of stakeholder groups. CONCLUSIONS: There are clear pathways towards ethical inclusion of pregnant people in the biomedical research agenda, and strong agreement across the HIV research community about the need for - and the promise of - advancing them. Those who fund, conduct, oversee and advocate for research can use the PHASES guidance to facilitate more, better and earlier evidence to optimize the health and wellbeing of pregnant people and their children.


Subject(s)
Acquired Immunodeficiency Syndrome , Biomedical Research , Coinfection , HIV Infections , Child , Female , HIV Infections/drug therapy , HIV Infections/prevention & control , Humans , Pregnancy , Stakeholder Participation
8.
BMJ Open ; 11(12): e054442, 2021 12 15.
Article in English | MEDLINE | ID: covidwho-1583096

ABSTRACT

INTRODUCTION: COVID-19 is a new viral-induced pneumonia caused by infection with a novel coronavirus, SARS-CoV-2. At present, there are few proven effective treatments. This early-phase experimental medicine protocol describes an overarching and adaptive trial designed to provide safety data in patients with COVID-19, pharmacokinetic (PK)/pharmacodynamic (PD) information and exploratory biological surrogates of efficacy, which may support further development and deployment of candidate therapies in larger scale trials of patients positive for COVID-19. METHODS AND ANALYSIS: Define is an ongoing exploratory multicentre-platform, open-label, randomised study. Patients positive for COVID-19 will be recruited from the following cohorts: (a) community cases; (b) hospitalised patients with evidence of COVID-19 pneumonitis; and (c) hospitalised patients requiring assisted ventilation. The cohort recruited from will be dependent on the experimental therapy, its route of administration and mechanism of action. Randomisation will be computer generated in a 1:1:n ratio. Twenty patients will be recruited per arm for the initial two arms. This is permitted to change as per the experimental therapy. The primary statistical analyses are concerned with the safety of candidate agents as add-on therapy to standard of care in patients with COVID-19. Secondary analysis will assess the following variables during treatment period: (1) the response of key exploratory biomarkers; (2) change in WHO ordinal scale and National Early Warning Score 2 (NEWS2) score; (3) oxygen requirements; (4) viral load; (5) duration of hospital stay; (6) PK/PD; and (7) changes in key coagulation pathways. ETHICS AND DISSEMINATION: The Define trial platform and its initial two treatment and standard of care arms have received a favourable ethical opinion from Scotland A Research Ethics Committee (REC) (20/SS/0066), notice of acceptance from The Medicines and Healthcare Products Regulatory Agency (MHRA) (EudraCT 2020-002230-32) and approval from the relevant National Health Service (NHS) Research and Development (R&D) departments (NHS Lothian and NHS Greater Glasgow and Clyde). Appropriate processes are in place in order to be able to consent adults with and without capacity while following the necessary COVID-19 safe procedures. Patients without capacity could be recruited via a legal representative. Witnessed electronic consent of participants or their legal representatives following consent discussions was established. The results of each study arm will be submitted for publication in a peer-reviewed journal as soon as the treatment arm has finished recruitment, data input is complete and any outstanding patient safety follow-ups have been completed. Depending on the results of these or future arms, data will be shared with larger clinical trial networks, including the Randomised Evaluation of COVID-19 Therapy trial (RECOVERY), and to other partners for rapid roll-out in larger patient cohorts. TRIAL REGISTRATION NUMBER: ISRCTN14212905, NCT04473053.


Subject(s)
Biomedical Research , COVID-19 , Clinical Trials, Phase I as Topic , Clinical Trials, Phase II as Topic , Electronics , Humans , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , State Medicine
9.
Medicina (Kaunas) ; 58(1)2021 Dec 24.
Article in English | MEDLINE | ID: covidwho-1580584

ABSTRACT

Background and Objectives: The presence of the new SARS-CoV-2 virus is causing enormous threats to people's health and lives, so quantifying the scientific productivity on mental health in times of pandemic is an urgent need, especially to expand the degree of knowledge on mental health problems in regions of low scientific productivity. The aim was to characterize the bibliometric indicators of scientific productivity on mental health during the pandemic in the PubMed Identifier database of the National Library of Medicine in the United States. Materials and Methods: A documentary study (bibliometric) of the scientific productivity on mental health in times of pandemic from January 2020 to June 2021 was carried out. The PubMed database was used to abstract the information from the original scientific articles. The data abstracted were: authors, year of publication, journal name, country, and language of publication. Results: We identified 47 original articles worldwide, which were published in 29 journals and in three languages (English, Spanish, and German). We observed three groups of countries that published on mental health topics. The first group comprised the largest number of publications, which were multicenter studies (six studies), followed by India (five studies), and Italy (four studies). A second group comprised Bangladesh, China, USA, and Spain, with 3 studies each; and a third group comprised 13 countries (Albania, Saudi Arabia, Argentina, Brazil, South Korea, Denmark, Ecuador, Egypt, Greece, Japan, Jordan, Kuwait, and New Zealand) with one study each. Conclusions: Bibliometric indicators of scientific productivity on mental health during the COVID-19 pandemic have ostensibly increased. We verified 47 studies in PubMed, which could serve to improve the understanding and management of COVID-19, as well as serve as a thought-provoking means for other countries and researchers to publish on the state of mental health during and post pandemic.


Subject(s)
Biomedical Research , COVID-19 , Bibliometrics , Humans , Mental Health , Pandemics , SARS-CoV-2
11.
BMC Med Ethics ; 22(1): 164, 2021 12 15.
Article in English | MEDLINE | ID: covidwho-1575423

ABSTRACT

BACKGROUND: The SARS-CoV-2 pandemic has highlighted once more the great need for comprehensive access to, and uncomplicated use of, pre-existing patient data for medical research. Enabling secondary research-use of patient-data is a prerequisite for the efficient and sustainable promotion of translation and personalisation in medicine, and for the advancement of public-health. However, balancing the legitimate interests of scientists in broad and unrestricted data-access and the demand for individual autonomy, privacy and social justice is a great challenge for patient-based medical research. METHODS: We therefore conducted two questionnaire-based surveys among North-German outpatients (n = 650) to determine their attitude towards data-donation for medical research, implemented as an opt-out-process. RESULTS: We observed a high level of acceptance (75.0%), the most powerful predictor of a positive attitude towards data-donation was the conviction that every citizen has a duty to contribute to the improvement of medical research (> 80% of participants approving data-donation). Interestingly, patients distinguished sharply between research inside and outside the EU, despite a general awareness that universities and public research institutions cooperate with commercial companies, willingness to allow use of donated data by the latter was very low (7.1% to 29.1%, depending upon location of company). The most popular measures among interviewees to counteract reservations against commercial data-use were regulation by law (61.4%), stipulating in the process that data are not sold or resold (84.6%). A majority requested control of both the use (46.8%) and the protection (41.5%) of the data by independent bodies. CONCLUSIONS: In conclusion, data-donation for medical research, implemented as a combination of legal entitlement and easy-to-exercise-right to opt-out, was found to be widely supported by German patients and therefore warrants further consideration for a transposition into national law.


Subject(s)
Biomedical Research , COVID-19 , Attitude , Humans , Privacy , SARS-CoV-2
12.
J Clin Invest ; 131(24)2021 Dec 15.
Article in English | MEDLINE | ID: covidwho-1573960

ABSTRACT

In this editorial, we describe the experience of the JCI editors during the COVID-19 pandemic. Our goal is to share how we operated during the pandemic, recount how the JCI contributed to the response, highlight some of the major papers we published on SARS-CoV-2 and COVID-19, and impart our insights in the hope that these are helpful to journal editors that may need to deal with similar types of crises in the future.


Subject(s)
Biomedical Research/trends , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/therapy , Publications , SARS-CoV-2 , China/epidemiology , Europe/epidemiology , Female , Humans , Male , Motivation , Pandemics , Public Health , Quarantine , Social Isolation , United States/epidemiology
13.
Gastroenterology ; 161(6): 1758-1763, 2021 12.
Article in English | MEDLINE | ID: covidwho-1541265
15.
Cardiovasc Res ; 117(9): 2045-2053, 2021 07 27.
Article in English | MEDLINE | ID: covidwho-1526155

ABSTRACT

Although coronavirus disease 2019 seems to be the leading topic in research number of outstanding studies have been published in the field of aorta and peripheral vascular diseases likely affecting our clinical practice in the near future. This review article highlights key research on vascular diseases published in 2020. Some studies have shed light in the pathophysiology of aortic aneurysm and dissection suggesting a potential role for kinase inhibitors as new therapeutic options. A first proteogenomic study on fibromuscular dysplasia (FMD) revealed a promising novel disease gene and provided proof-of-concept for a protein/lipid-based FMD blood test. The role of NADPH oxidases in vascular physiology, and particularly endothelial cell differentiation, is highlighted with potential for cell therapy development. Imaging of vulnerable plaque has been an intense field of research. Features of plaque vulnerability on magnetic resonance imaging as an under-recognized cause of stroke are discussed. Major clinical trials on lower extremity peripheral artery disease have shown added benefit of dual antithrombotic (aspirin plus rivaroxaban) treatment.


Subject(s)
Aortic Diseases , Biomedical Research/trends , Peripheral Vascular Diseases , Animals , Aortic Diseases/diagnosis , Aortic Diseases/epidemiology , Aortic Diseases/genetics , Aortic Diseases/therapy , COVID-19 , Clinical Trials as Topic , Diffusion of Innovation , Humans , Peripheral Vascular Diseases/diagnosis , Peripheral Vascular Diseases/epidemiology , Peripheral Vascular Diseases/genetics , Peripheral Vascular Diseases/therapy , Prognosis
16.
PLoS One ; 16(11): e0258660, 2021.
Article in English | MEDLINE | ID: covidwho-1511817

ABSTRACT

Due to COVID-19 precautions, the Vanderbilt University summer biomedical undergraduate research program, the Vanderbilt Summer Science Academy (VSSA), rapidly transitioned from offering an in-person training program to a virtual seminar format. Our program typically supports undergraduate development through research and/or clinical experience, meeting with individuals pursuing postgraduate training, and providing career development advice. Evidence supports the idea that summer programs transform undergraduates by clarifying their interest in research and encouraging those who haven't previously considered graduate studies. We were interested in exploring whether a virtual, synchronous program would increase participants' scientific identity and clarify postgraduate career planning. Rather than create a virtual research exposure, our 5-week "Virtual VSSA" program aimed to simulate the casual connections that would naturally be made with post-undergraduate trainees during a traditional summer program. In seminars, presenters discussed 1) their academic journey, explaining their motivations, goals, and reasons for pursuing a career in science as well as 2) a professional story that illustrated their training. Seminars included Vanderbilt University and Medical School faculty, M.D., MD/Ph.D., as well as Ph.D. students from diverse scientific and personal backgrounds. In addition, weekly informational sessions provided an overview of the nature of each degree program along with admissions advice. Through pre-and post-program surveys, we found that students who registered for this experience already strongly identified with the STEMM community (Science, Technology, Engineering, Mathematics, and Medicine). However, participation in the Virtual VSSA increased their sense of belonging. We also uncovered a gap in participants' understanding of postgraduate pathways prior to participation and found that our program significantly increased their self-reported understanding of postgraduate programs. It also increased their understanding of why someone would pursue a Ph.D. or Ph.D./MD versus M.D. These changes did not uniformly impact participants' planned career paths. Overall, by providing personal, tangible stories of M.D., MD/Ph.D., and Ph.D. training, the Virtual VSSA program offered seminars that positively impacted students' sense of belonging with and connection to the STEMM disciplines.


Subject(s)
Engineering/education , Mathematics/education , Technology/education , Academies and Institutes , Biomedical Research/education , COVID-19/epidemiology , Career Choice , Faculty/education , Humans , Knowledge , Mentors/education , Minority Groups/education , Schools, Medical , Students , Universities
17.
BMJ ; 375: n2736, 2021 11 09.
Article in English | MEDLINE | ID: covidwho-1511459
18.
Elife ; 102021 06 16.
Article in English | MEDLINE | ID: covidwho-1513072

ABSTRACT

Research in many different areas of medicine will benefit from new approaches to peer review and publishing.


Subject(s)
Peer Review, Research , Preprints as Topic , Publishing , Biomedical Research , COVID-19 , Humans
20.
PLoS One ; 16(10): e0258935, 2021.
Article in English | MEDLINE | ID: covidwho-1496518

ABSTRACT

BACKGROUND: Retraction of published research can reduce the dissemination of incorrect or misleading information, but concerns have been raised about the clarity and rigor of the retraction process. Failure to clearly and consistently retract research has several risks, for example discredited or erroneous research may inform health research studies (e.g. clinical trials), policies and practices, potentially rendering these unreliable. OBJECTIVE: To investigate consistency and clarity of research retraction, based on a case study of retracted Covid-19 research. STUDY DESIGN: A cross-sectional study of retracted Covid-19 articles reporting empirical research findings, based on searches of Medline, Embase and Scopus on 10th July and 19th December 2020. KEY RESULTS: We included 46 retracted Covid-19 articles. The number eligible for inclusion nearly doubled, from 26 to 46, in five months. Most articles (67%) were retracted from scientific journals and the remainder from preprint servers. Key findings: (1) reasons for retraction were not reported in 33% (15/46) of cases; (2) time from publication to retraction could not be determined in 43% (20/46) of cases; (3) More than half (59%) of retracted Covid-19 articles (27/46) remained available as original unmarked electronic documents after retraction (33% as full text and 26% as an abstract only). Sources of articles post-retraction were preprint servers, ResearchGate and, less commonly, websites including PubMed Central and the World Health Organization. A retracted journal article which controversially claimed a link between 5G technology and Covid-19 remains available in its original full text from at least 60 different websites. CONCLUSIONS: The retraction process is inconsistent and often ambiguous, with more than half of retracted Covid-19 research articles remaining available, unmarked, from a wide range of online sources. There is an urgent need to improve guidance on the retraction process and to extend this to cover preprint servers. We provide structured recommendations to address these concerns and to reduce the risks that arise when retracted research is inappropriately cited.


Subject(s)
Biomedical Research , COVID-19 , Cross-Sectional Studies , Journal Impact Factor , Plagiarism , Publishing , Scientific Misconduct
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