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.

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.

Addressing issues at the forefront of interest for the Clinical Trial Materials Professional (CTMP), this Second Edition highlights the most critical concepts related to the planning, manufacturing, packaging, labeling, distribution, reconciliation, and quality and regulatory control of clinical trial materials-offering an authoritative selection of chapters on the current and evolving state of clinical supplies operations by esteemed researchers and consultants in industry.

"In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.

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.

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

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.

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.