The pace of therapeutic advances in the treatment of cardiovascular diseases is rapid, and new clinically-relevant information appears with such frequency that it can be extremely challenging for clinicians to keep up. Still, knowledge and interpretation of major clinical trials is crucial for the range of clinicians who manage cardiovascular patients, especially since important trial evidence often needs to be implemented soon after it is published. Confidently apply gold standard treatment for 10 of the most critical areas of cardiology Written by an international team of experts, Cardiovascular Clinical Trials: Putting the Evidence into Practice: Provides a succinct overview of recent major clinical trials - the gold standard for all medical treatment - across all the major cardiovascular subspecialties, to ensure you’re up-to-date on the most critical findings Guides cardiology trainees and clinicians on how cardiovascular clinical trials are designed and conducted, including statistical methodology, so you can conduct and/or appraise future trials yourself Addresses methodology as well as clinical effectiveness Offers evidence-based assessments on the most effective treatments and authoritative clinical information on management of the conditions so you can confidently apply what you learn Physicians, surgeons, specialist nurses – any clinician seeking an accessible resource for designing and conducting cardiovascular trials and then translating their results into practice will appreciate this book’s clear guidance and succinct and practical approach.

This text, aimed at the clinical cardiologist, covers the planning of and partcipation in a clinical trial. It interprets the importance of past clinical trials in current clinical practice.

This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low. One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, the need for an advanced infrastructure for complex randomization and clinical supply scenarios, change management for process and behavior modifications, extensive resource requirements for the planning and design of adaptive trials and the potential to relegate key decision makings to outside entities. There have been limited publications that address these practical considerations and recommend best practices and solutions. This book fills this publication gap, providing guidance on practical considerations for adaptive trial design and implementation. The book comprises three parts: Part I focuses on practical considerations from a design perspective, whereas Part II delineates practical considerations related to the implementation of adaptive trials. Putting it all together, Part III presents four illustrative case studies ranging from description and discussion of specific adaptive trial design considerations to the logistic and regulatory issues faced in trial implementation. Bringing together the expertise of leading key opinion leaders from pharmaceutical industry, academia, and regulatory agencies, this book provides a balanced and comprehensive coverage of practical considerations for adaptive trial design and implementation.

An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.

The Social Security Administration (SSA) uses a screening tool called the Listing of Impairments to identify claimants who are so severely impaired that they cannot work at all and thus immediately qualify for benefits. In this report, the IOM makes several recommendations for improving SSA's capacity to determine disability benefits more quickly and efficiently using the Listings.

Since the publication of the second edition of this volume, 3D echocardiography has penetrated the clinical arena and become an indispensable tool for patient care. The previous edition, which was highly commended at the British Medical Book Awards, has been updated with recent publications and improved images. This third edition has added important new topics such as 3D Printing, Surgical and Transcatheter Management, Artificial Valves, and Infective Endocarditis. The book begins by describing the principles of 3D echocardiography, then proceeds to discuss its application to the imaging of • Left and Right Ventricle, Stress Echocardiography • Left Atrium, Hypertrophic Cardiomyopathy • Mitral Regurgitation with Surgical and Nonsurgical Procedures • Mitral Stenosis and Percutaneous Mitral Valvuloplasty • Aortic Stenosis with TAVI / TAVR • Aortic and Tricuspid Regurgitation • Adult Congenital Heart Disease, Aorta • Speckle Tracking, Cardiac Masses, Atrial Fibrillation KEY FEATURES In-depth clinical experiences of the use of 3D/2D echo by world experts Latest findings to demonstrate clinical values of 3D over 2D echo One-click view of 263 innovative videos and 352 high-resolution 3D/2D color images in a supplemental eBook.

Hemodynamics makes it possible to characterize in a quantitative way, the function of the heart and arterial system, thereby producing information about what genetic and molecular processes are of importance for cardiovascular function. Snapshots of Hemodynamics: An Aid for Clinical Research and Graduate Education by Nico Westerhof, Nikos Stergiopulos and Mark I. M. Noble is a quick reference guide designed to help basic and clinical researchers as well as graduate students to understand hemodynamics. The layout of the book provides short and independent chapters that provide teaching diagrams as well as clear descriptions of the essentials of basic and applied principles of hemodynamics. References are provided at the end of each chapter for further reading and reference.

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.

Stem Cell and Gene Therapy for Cardiovascular Disease is a state-of-the-art reference that combines, in one place, the breadth and depth of information available on the topic. As stem cell and gene therapies are the most cutting-edge therapies currently available for patients with heart failure, each section of the book provides information on medical trials from contributors and specialists from around the world, including not only what has been completed, but also what is planned for future research and trials. Cardiology researchers, basic science clinicians, fellows, residents, students, and industry professionals will find this book an invaluable resource for further study on the topic. - Provides information on stem and gene therapy medical trials from contributors and specialists around the world, including not only what has been completed, but also what is planned for future research and trials - Presents topics that can be applied to allogeneic cells, mesenchymal cells, gene therapy, cardiomyoctyes, iPS cells, MAPC's, and organogenesis - Covers the three areas with the greatest clinical trials to date: chronic limb ischemia, chronic angina, and acute MI - Covers the prevailing opinions on how to harness the body's natural repair mechanisms - Ideal resource for cardiology researchers, basic science clinicians, fellows, residents, students, and industry professionals

The ESC Handbook on Cardiovascular Pharmacotherapy, based on the most recent guidelines in cardiovascular pharmacology, and containing a comprehensive A-Z formulary of common and less commonly used cardiac drugs and drug groups, provides practical and accessible guidance on all areas of drug prescribing.