Sharing Clinical Trial Data
Sharing Clinical Trial Data

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2015-04-20

Total Pages: 236

ISBN-13: 0309316324

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Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

The Ethics of Pandemics
The Ethics of Pandemics

Author: Meredith Celene Schwartz

Publisher: Broadview Press

Published: 2020-07-30

Total Pages: 164

ISBN-13: 1460407202

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A portion of the revenue from this book’s sales will be donated to Doctors Without Borders to assist in the fight against COVID-19. The rapid spread of COVID-19 has had an unprecedented impact on modern health-care systems and has given rise to a number of complex ethical issues. This collection of readings and case studies offers an overview of some of the most pressing of these issues, such as the allocation of ventilators and other scarce resources, the curtailing of standard privacy measures for the sake of public health, and the potential obligations of health-care professionals to continue operating in dangerous work environments.

COVID-19: An Update
COVID-19: An Update

Author: James D. Chalmers

Publisher: European Respiratory Society

Published: 2024-09-01

Total Pages: 335

ISBN-13: 1849841829

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In May 2023, WHO declared that COVID-19 was no longer a public health emergency of international concern. In 2024, COVID-19 certainly has not gone away, but we can now take a more reflective look at the pandemic. This issue of the ERS Monograph does just that, bringing together a truly international group of experts, as befits a global illness, to consider areas such as: long-term sequelae in airway disease, interstitial lung disease, and in the immunocompromised; therapeutics in the community, in hospital and in the intensive care unit; and the pathophysiology and management of long COVID. The Guest Editors also consider the impact of COVID-19 on clinical research and scientific publishing, as well as looking to the future, considering what can be learnt from the pandemic.

COVID-19
COVID-19

Author: Debmalya Barh

Publisher: CRC Press

Published: 2022-03-03

Total Pages: 402

ISBN-13: 1000510123

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The COVID-19 pandemic has affected the entire world in an unprecedented way, and this book provides an overview of the historical facts as well as ongoing approaches to tackle the COVID-19 pandemic. Experts of the respective domains provide details on anti-SARS-CoV-2 drug strategies, including repurposing drugs used for other indications and the development of novel drugs looking at different approaches to target virus entry and replication. COVID-19 vaccine development based on inactivated and attenuated live virus, protein subunit and peptide-based vaccines and utilization of vaccine candidates based on viral vectors, DNA and RNA are presented for both preclinical studies and clinical trials. Key Features Explains the background of the COVID-19 pandemic, the current progress in the development of treatments and prevention of COVID-19 including future aspects of dealing with the pandemic Serves as a timely repository of knowledge on COVID-19 for researchers and medical professionals engaged in its management

Coronavirus Disease (COVID-19): Pathophysiology, Epidemiology, Clinical Management and Public Health Response
Coronavirus Disease (COVID-19): Pathophysiology, Epidemiology, Clinical Management and Public Health Response

Author:

Publisher: Frontiers Media SA

Published: 2023-01-25

Total Pages: 1671

ISBN-13: 288974101X

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Volume I.A An outbreak of a respiratory disease first reported in Wuhan, China in December 2019 and the causative agent was discovered in January 2020 to be a novel betacoronovirus of the same subgenus as SARS-CoV and named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Coronavirus disease 2019 (COVID-19) has rapidly disseminated worldwide, with clinical manifestations ranging from mild respiratory symptoms to severe pneumonia and a fatality rate estimated around 2%. Person to person transmission is occurring both in the community and healthcare settings. The World Health Organization (WHO) has recently declared the COVID-19 epidemic a public health emergency of international concern. The ongoing outbreak presents many clinical and public health management challenges due to limited understanding of viral pathogenesis, risk factors for infection, natural history of disease including clinical presentation and outcomes, prognostic factors for severe illness, period of infectivity, modes and extent of virus inter-human transmission, as well as effective preventive measures and public health response and containment interventions. There are no antiviral treatment nor vaccine available but fast track research and development efforts including clinical therapeutic trials are ongoing across the world. Managing this serious epidemic requires the appropriate deployment of limited human resources across all cadres of health care and public health staff, including clinical, laboratory, managerial and epidemiological data analysis and risk assessment experts. It presents challenges around public communication and messaging around risk, with the potential for misinformation and disinformation. Therefore, integrated operational research and intervention, learning from experiences across different fields and settings should contribute towards better understanding and managing COVID-19. This Research Topic aims to highlight interdisciplinary research approaches deployed during the COVID-19 epidemic, addressing knowledge gaps and generating evidence for its improved management and control. It will incorporate critical, theoretically informed and empirically grounded original research contributions using diverse approaches, experimental, observational and intervention studies, conceptual framing, expert opinions and reviews from across the world. The Research Topic proposes a multi-dimensional approach to improving the management of COVID-19 with scientific contributions from all areas of virology, immunology, clinical microbiology, epidemiology, therapeutics, communications as well as infection prevention and public health risk assessment and management studies.

COVID-19
COVID-19

Author: Aurelie Fabre

Publisher: European Respiratory Society

Published: 2021-12-01

Total Pages: 277

ISBN-13: 1849841497

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The story of COVID-19 now seems so familiar: from the first reported case of a new respiratory infection in China in December 2019, to a pandemic that rapidly changed the world. Respiratory clinicians and scientists were at the forefront of delivering healthcare for people with COVID-19, leading efforts to understand this novel virus and disease, and developing and testing strategies to better prevent and treat it. These endeavours extended not only to the acute illness, but also to understanding the longer-term consequences. The pace of knowledge acquisition was rapid but is now maturing. This Monograph therefore provides a timely and valuable state-of-the-art summary for clinicians and scientists on our understanding of this virus and its consequences to date. It is essential reading for all those involved in the care of people who are or who have been affected by COVID-19.

Coronavirus Disease (COVID-19): Pathophysiology, Epidemiology, Clinical Management and Public Health Response, Volume II (volume I.A)
Coronavirus Disease (COVID-19): Pathophysiology, Epidemiology, Clinical Management and Public Health Response, Volume II (volume I.A)

Author: Thomas Rawson

Publisher: Frontiers Media SA

Published: 2023-05-31

Total Pages: 771

ISBN-13: 2889764656

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Almost nine months since the first recorded case, the novel betacoronovirus; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has now passed 18 million confirmed cases. The multi-disciplinary work of researchers worldwide has provided a far deeper understanding of COVID-19 pathogenesis, clinical treatment and outcomes, lethality, disease-spread dynamics, period of infectivity, containment interventions, as well as providing a wealth of relevant epidemiological data. With 27 vaccines currently undergoing human trials, and countries worldwide continuing to battle case numbers, or prepare for resurgences, the need for efficient, high-quality pipelines for peer-reviewed research remains as crucial as ever.