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4.
Neuron ; 109(20): 3199-3202, 2021 10 20.
Article in English | MEDLINE | ID: covidwho-1474921

ABSTRACT

The COVID-19 pandemic has had a profound impact on neuroscientists, including those involved in translational research. In this NeuroView, we discuss the positive and negative effects of the pandemic on preclinical research and clinical studies in humans.


Subject(s)
Alzheimer Disease/epidemiology , Biomedical Research/methods , COVID-19/epidemiology , Clinical Trials as Topic/methods , Neurology/methods , Alzheimer Disease/therapy , Biomedical Research/trends , COVID-19/prevention & control , Humans , Neurodegenerative Diseases/epidemiology , Neurodegenerative Diseases/therapy , Neurology/trends
6.
Stroke ; 52(11): 3739-3747, 2021 11.
Article in English | MEDLINE | ID: covidwho-1443690

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic has presented unique challenges to stroke care and research internationally. In particular, clinical trials in stroke are vulnerable to the impacts of the pandemic at multiple stages, including design, recruitment, intervention, follow-up, and interpretation of outcomes. A carefully considered approach is required to ensure the appropriate conduct of stroke trials during the pandemic and to maintain patient and participant safety. This has been recently addressed by the International Council for Harmonisation which, in November 2019, released an addendum to the Statistical Principles for Clinical Trials guidelines entitled Estimands and Sensitivity Analysis in Clinical Trials. In this article, we present the International Council for Harmonisation estimand framework for the design and conduct of clinical trials, with a specific focus on its application to stroke clinical trials. This framework aims to align the clinical and scientific objectives of a trial with its design and end points. It also encourages the prospective consideration of potential postrandomization intercurrent events which may occur during a trial and either impact the ability to measure an end point or its interpretation. We describe the different categories of such events and the proposed strategies for dealing with them, specifically focusing on the COVID-19 pandemic as a source of intercurrent events. We also describe potential practical impacts posed by the COVID-19 pandemic on trials, health systems, study groups, and participants, all of which should be carefully reviewed by investigators to ensure an adequate practical and statistical strategy is in place to protect trial integrity. We provide examples of the implementation of the estimand framework within hypothetical stroke trials in intracerebral hemorrhage and stroke recovery. While the focus of this article is on COVID-19 impacts, the strategies and principles proposed are well suited for other potential events or issues, which may impact clinical trials in the field of stroke.


Subject(s)
COVID-19 , Clinical Trials as Topic/methods , Data Interpretation, Statistical , Research Design , Stroke/therapy , Clinical Trials as Topic/standards , Guidelines as Topic , Humans , Implementation Science , SARS-CoV-2
9.
Ann Rheum Dis ; 80(10): 1286-1298, 2021 10.
Article in English | MEDLINE | ID: covidwho-1406632

ABSTRACT

BACKGROUND: Despite growing interest, there is no guidance or consensus on how to conduct clinical trials and observational studies in populations at risk of rheumatoid arthritis (RA). METHODS: An European League Against Rheumatism (EULAR) task force formulated four research questions to be addressed by systematic literature review (SLR). The SLR results informed consensus statements. One overarching principle, 10 points to consider (PTC) and a research agenda were proposed. Task force members rated their level of agreement (1-10) for each PTC. RESULTS: Epidemiological and demographic characteristics should be measured in all clinical trials and studies in at-risk individuals. Different at-risk populations, identified according to clinical presentation, were defined: asymptomatic, musculoskeletal symptoms without arthritis and early clinical arthritis. Study end-points should include the development of subclinical inflammation on imaging, clinical arthritis, RA and subsequent achievement of arthritis remission. Risk factors should be assessed at baseline and re-evaluated where appropriate; they include genetic markers and autoantibody profiling and additionally clinical symptoms and subclinical inflammation on imaging in those with symptoms and/or clinical arthritis. Trials should address the effect of the intervention on risk factors, as well as progression to clinical arthritis or RA. In patients with early clinical arthritis, pharmacological intervention has the potential to prevent RA development. Participants' knowledge of their RA risk may inform their decision to participate; information should be provided using an individually tailored approach. CONCLUSION: These consensus statements provide data-driven guidance for rheumatologists, health professionals and investigators conducting clinical trials and observational studies in individuals at risk of RA.


Subject(s)
Arthritis, Rheumatoid/prevention & control , Asymptomatic Diseases , Clinical Trials as Topic/methods , Observational Studies as Topic/methods , Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/diagnostic imaging , Arthritis, Rheumatoid/immunology , Arthritis, Rheumatoid/therapy , Europe , Humans , Rheumatology , Risk Factors , Severity of Illness Index , Societies, Medical
12.
Clin Dermatol ; 39(1): 104-106, 2021.
Article in English | MEDLINE | ID: covidwho-1300697

ABSTRACT

The clinical trials industry faces a number of challenges during the evolving coronavirus disease 2019 (COVID-19) pandemic, for example, site closures, mandatory self-isolation, travel restrictions, interruptions to delivery of investigational product, or staff or participants becoming infected with severe acute respiratory syndrome coronavirus 2. These challenges can pose difficulties in adhering to visit schedules, performing laboratory testing, conducting protocol-specified procedures, and administration of investigational product. As a result, clinical trial sites, contract research organizations, and sponsors have had to act swiftly to ensure that trial patients are safe and systems are in place for continuing trials. Protocols should also be amended to reflect changes and approved by an ethics board. The authors provide practical considerations and recommendations for dermatology clinical trial operations during the COVID-19 pandemic.


Subject(s)
COVID-19/prevention & control , Clinical Trials as Topic/methods , Dermatology , Patient Safety , COVID-19/epidemiology , Humans , SARS-CoV-2
13.
J Diabetes Sci Technol ; 15(5): 1181-1187, 2021 09.
Article in English | MEDLINE | ID: covidwho-1280566

ABSTRACT

Complications of Coronavirus Disease 2019 (COVID-19) occur with increased frequency in people admitted to the hospital with diabetes or hyperglycemia. The increased risk for COVID-19 infections in the presence of these metabolic conditions is in part due to overlapping pathophysiologic features of COVID-19, diabetes, and glucose control. Various antiviral treatments are being tested in COVID-19 patients. We believe that in these trials, it will be useful to evaluate treatment effect differences in patients stratified according to whether they have diabetes or hyperglycemia. In this way, it will be possible to better facilitate development of antiviral treatments that are most specifically beneficial for the large subset of COVID-19 patients who have diabetes or hyperglycemia.


Subject(s)
COVID-19/epidemiology , COVID-19/therapy , Clinical Trials as Topic , Diabetes Mellitus , Hyperglycemia , Antiviral Agents/therapeutic use , Blood Glucose/metabolism , COVID-19/blood , COVID-19/complications , Clinical Trials as Topic/methods , Clinical Trials as Topic/statistics & numerical data , Data Accuracy , Diabetes Mellitus/blood , Diabetes Mellitus/epidemiology , Diabetes Mellitus/therapy , Hospitalization/statistics & numerical data , Humans , Hyperglycemia/blood , Hyperglycemia/epidemiology , Hyperglycemia/therapy , Research Design , Risk Factors , SARS-CoV-2
15.
AAPS PharmSciTech ; 22(5): 172, 2021 Jun 07.
Article in English | MEDLINE | ID: covidwho-1261286

ABSTRACT

Vaccination development and production was an essential question for the prevention and global control of COVID-19. The strong support from governing authorities such as Operation Warp Speed and robust funding has led to the development and authorization of the tozinameran (BNT162b2) vaccine. The BNT162b2 vaccine is a lipid nanoparticle-encapsulated mRNA that encodes for SARS-CoV-2 spike protein, the main site for neutralizing antibodies. Once it binds with the host cells, the lipid nanoparticles enable the transfer of the RNA, causing S antigens' expression of the SARS-CoV-2, conferring immunity. The vaccine is administered as a 2-dose regime 21 days apart for individuals 16 years and older. Pfizer-BioNTech's BNT162b2 vaccine was the first candidate to receive FDA-Emergency Use Authorization (EUA) on December 11, 2020. During phase 2/3 clinical trials, 95% efficacy was reported among 37,706 participants over the age of 16 who received the BNT162b2 vaccination; additionally, 52% efficacy was noted 12 days following the administration of the first dose of BNT162b2, reflecting early protection of COVID-19. The BNT162b2 vaccine has exhibited 100% efficacy in clinical trials of adolescents between the ages of 12 and 15. Clinical trials in pregnant women and children under the age of 12 are expected to also exhibit promising results. This review article encompasses tozinameran (BNT162b2) vaccine journey, summarizing the BNT162b1 and BNT162b2 vaccines from preclinical studies, clinical trial phases, dosages, immune response, adverse effects, and FDA-EUA.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Clinical Trials as Topic/methods , Drug Approval/methods , SARS-CoV-2/drug effects , Animals , Antibodies, Neutralizing/drug effects , Antibodies, Neutralizing/metabolism , COVID-19/epidemiology , COVID-19/metabolism , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/metabolism , Clinical Trials as Topic/legislation & jurisprudence , Drug Approval/legislation & jurisprudence , Drug Evaluation, Preclinical/methods , Exanthema/chemically induced , Female , Humans , Male , SARS-CoV-2/metabolism , Spike Glycoprotein, Coronavirus/drug effects , Spike Glycoprotein, Coronavirus/metabolism , Vaccination/legislation & jurisprudence , Vaccination/methods
17.
Expert Rev Vaccines ; 20(7): 857-880, 2021 07.
Article in English | MEDLINE | ID: covidwho-1254221

ABSTRACT

Introduction: The coronavirus disease 2019 (COVID-19) pandemic continues to spread worldwide and vaccination remains the most effective approach to control COVID-19. Currently, at least ten COVID-19 vaccines have been authorized under emergency authorization. However, these vaccines still face many challenges.Areas covered: This study reviews the concept and mechanisms of trained immunity induced by the Bacille Calmette Guérin (BCG) vaccine and identifies questions that should be answered before the BCG vaccine could be used to combat COVID-19 pandemic. Moreover, we present for the first time the details of current BCG vaccine clinical trials, which are underway in various countries, to assess its effectiveness in combating the COVID-19 pandemic. Finally, we discuss the challenges of COVID-19 vaccines and opportunities for the BCG vaccine. The literature was found by searching the PubMed (https://pubmed.ncbi.nlm.nih.gov/), Web of Science (www.webofknowledge.com), Embase (https://www.embase.com), and CNKI (https://www.cnki.net/) databases. The date was set as the default parameter for each database.Expert opinion: The advantages of the BCG vaccine can compensate for the shortcomings of other COVID-19 vaccines. If the efficacy of the BCG vaccine against COVID-19 is confirmed by these clinical trials, the BCG vaccine may be essential to resolve the challenges faced by COVID-19 vaccines.


Subject(s)
BCG Vaccine/immunology , COVID-19 Vaccines/immunology , COVID-19/immunology , COVID-19/prevention & control , Clinical Trials as Topic/methods , Immunity, Innate/immunology , Adjuvants, Immunologic/administration & dosage , BCG Vaccine/administration & dosage , COVID-19 Vaccines/administration & dosage , Humans , Immunity, Innate/drug effects , Pandemics
18.
Can J Cardiol ; 37(9): 1353-1364, 2021 09.
Article in English | MEDLINE | ID: covidwho-1252583

ABSTRACT

The COVID-19 crisis led to a flurry of clinical trials activity. The COVID-evidence database shows 2814 COVID-19 randomized trials registered as of February 16, 2021. Most were small (only 18% have a planned sample size > 500) and the rare completed ones have not provided published results promptly (only 283 trial publications as of February 2021). Small randomized trials and observational, nonrandomized analyses have not had a successful track record and have generated misleading expectations. Different large trials on the same intervention have generally been far more efficient in producing timely and consistent evidence. The rapid generation of evidence and accelerated dissemination of results have led to new challenges for systematic reviews and meta-analyses (eg, rapid, living, and scoping reviews). Pressure to regulatory agencies has also mounted with massive emergency authorizations, but some of them have had to be revoked. Pandemic circumstances have disrupted the way trials are conducted; therefore, new methods have been developed and adopted more widely to facilitate recruitment, consent, and overall trial conduct. On the basis of the COVID-19 experience and its challenges, planning of several large, efficient trials, and wider use of adaptive designs might change the future of clinical research. Pragmatism, integration in clinical care, efficient administration, promotion of collaborative structures, and enhanced integration of existing data and facilities might be several of the legacies of COVID-19 on future randomized trials.


Subject(s)
COVID-19 , Pandemics , Randomized Controlled Trials as Topic , COVID-19/therapy , Clinical Trials as Topic/methods , Clinical Trials as Topic/standards , Clinical Trials as Topic/statistics & numerical data , Drug Repositioning , Humans , Randomized Controlled Trials as Topic/methods , Randomized Controlled Trials as Topic/standards , Randomized Controlled Trials as Topic/statistics & numerical data , Research Design/standards , SARS-CoV-2
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