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.

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.

Thoroughly updated for its Third Edition, this pocket-sized handbook provides easy access to clinical trial data that are crucial in therapeutic decision-making. The book enables clinicians to quickly review the studies that support or refute an intervention and choose the most appropriate, cost-effective treatment. Each chapter summarizes the pathophysiology of a disease and guideline-recommended diagnostic tests and treatments, and presents synopses of the major clinical trials for all therapies. New sections in this Third Edition cover peripheral artery disease and drug-eluting stents. This edition also features expanded coverage of pacers and ICDs and an expanded section on preventive pre-hospital cardiology.

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.

Designed for includsion on Willerson's CD-ROM library, this small and concise handbook fills an important niche in the literature. There is no other single source of objective information on the many clinical trials conducted worldwide. A perfect companion to Willerson & Cohn's Cardiovascular Medicine text. Easy to use one column tabular form, with lots of bulleted lists Divided into twelve major areas of cardiology research Key results and important illustrations from the definitive recent journal articles An introduction by Dr James T Willerson to each section, pointing out the import lessons and key facts within each area of cardiology

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.