Practical Considerations for Adaptive Trial Design and Implementation

Practical Considerations for Adaptive Trial Design and Implementation
Author: Weili He
Publisher: Springer
Total Pages: 420
Release: 2014-10-15
Genre: Medical
ISBN: 1493911007


Download Practical Considerations for Adaptive Trial Design and Implementation Book in PDF, Epub and Kindle

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.

Cardiac Regeneration

Cardiac Regeneration
Author: Masaki Ieda
Publisher: Springer
Total Pages: 274
Release: 2017-10-27
Genre: Medical
ISBN: 3319561065


Download Cardiac Regeneration Book in PDF, Epub and Kindle

This Volume of the series Cardiac and Vascular Biology offers a comprehensive and exciting, state-of-the-art work on the current options and potentials of cardiac regeneration and repair. Several techniques and approaches have been developed for heart failure repair: direct injection of cells, programming of scar tissue into functional myocardium, and tissue-engineered heart muscle support. The book introduces the rationale for these different approaches in cell-based heart regeneration and discusses the most important considerations for clinical translation. Expert authors discuss when, why, and how heart muscle can be salvaged. The book represents a valuable resource for stem cell researchers, cardiologists, bioengineers, and biomedical scientists studying cardiac function and regeneration.

Myocardial Protection

Myocardial Protection
Author: Tomas A. Salerno
Publisher: John Wiley & Sons
Total Pages: 344
Release: 2008-04-15
Genre: Medical
ISBN: 1405178434


Download Myocardial Protection Book in PDF, Epub and Kindle

Myocardial protection is regarded as one of the most important, yet also most controversial aspects of cardiac surgery. There has been considerable improvement in myocardial protection strategies over recent years, utilising a variety of new approaches to treat cardiac diseases, and this text is intended to embrace the state of the art in this field. The book summarises the state of knowledge on all aspects of myocardial protection, including the latest in the treatment of cardiac diseases, robotics, pediatric surgery and the treatment of cardiac failure. Robotic surgery, valvular surgery, pediatric surgery and coronary surgery are all covered by renowned experts, producing a comprehensive, forward-looking view of the field of myocardial protection. This book should function to update physicians and surgeons interested in the field of cardiac surgery on the current state of knowledge on myocardial protection.

The ESC Textbook of Preventive Cardiology

The ESC Textbook of Preventive Cardiology
Author: Stephan Gielen
Publisher: European Society of Cardiology
Total Pages: 369
Release: 2015
Genre: Medical
ISBN: 0199656657


Download The ESC Textbook of Preventive Cardiology Book in PDF, Epub and Kindle

"EACPR, European Association for Cardiovascular Prevention and Rehabilitation -- European Society of Cardiology."

Therapeutic Strategies for Heart Failure

Therapeutic Strategies for Heart Failure
Author: Naoki Sato
Publisher: Springer
Total Pages: 98
Release: 2018-01-24
Genre: Medical
ISBN: 4431560653


Download Therapeutic Strategies for Heart Failure Book in PDF, Epub and Kindle

This book introduces pathophysiology and practical heart failure (HF) management at the acute, in-hospital stages during hospitalization and also in the end-stages of HF. Given its increasing incidence and prevalence, we live in a world that is essentially facing an HF pandemic. A country with an ageing population, Japan is unique in terms of the selection of medical treatment, diagnostic techniques, team managing and other approaches. This book sheds new light on the clinical challenges involved in reducing re-hospitalization and improving patients’ prognosis and ADL/QOL, while also reporting on the status quo in Japan. By highlighting these challenges and the methods used to address them, it will encourage experts around the globe to intensively discuss and accelerate research in this field. Including contributions by authors who have played central roles in managing HF in Japan, the book offers an indispensable guide not only for clinicians, technicians and nurses in this field, but also for general physicians, emergency physicians and all others who are involved in the management of acute and end-stage HF.

Cardioprotection

Cardioprotection
Author: Derek Hausenloy
Publisher: Oxford University Press
Total Pages: 138
Release: 2009-08-20
Genre: Medical
ISBN: 019954476X


Download Cardioprotection Book in PDF, Epub and Kindle

Coronary heart disease (CHD) is the leading cause of death worldwide. Cardioprotection refers to the prevention of CHD and the clinical improvement in patients suffering from cardiovascular problems.

Cardiovascular Disability

Cardiovascular Disability
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 304
Release: 2010-12-04
Genre: Medical
ISBN: 030915698X


Download Cardiovascular Disability Book in PDF, Epub and Kindle

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.

Acute Heart Failure

Acute Heart Failure
Author: Alexandre Mebazaa
Publisher: Springer Science & Business Media
Total Pages: 922
Release: 2009-12-24
Genre: Medical
ISBN: 1846287820


Download Acute Heart Failure Book in PDF, Epub and Kindle

For many years, there has been a great deal of work done on chronic congestive heart failure while acute heart failure has been considered a difficult to handle and hopeless syndrome. However, in recent years acute heart failure has become a growing area of study and this is the first book to cover extensively the diagnosis and management of this complex condition. The book reflects the considerable amounts of new data reported and many new concepts which have been proposed in the last 3-4 years looking at the epidemiology, diagnostic and treatment of acute heart failure.

Novel Strategies in Ischemic Heart Disease

Novel Strategies in Ischemic Heart Disease
Author: Umashankar Lakshmanadoss
Publisher: BoD – Books on Demand
Total Pages: 466
Release: 2012-02-29
Genre: Medical
ISBN: 9535101846


Download Novel Strategies in Ischemic Heart Disease Book in PDF, Epub and Kindle

The first edition of this book will provide a comprehensive overview of ischemic heart disease, including epidemiology, risk factors, pathogenesis, clinical presentation, diagnostic tests, differential diagnosis, treatment, complications and prognosis. Also discussed are current treatment options, protocols and diagnostic procedures, as well as the latest advances in the field. The book will serve as a cutting-edge point of reference for the basic or clinical researcher, and any clinician involved in the diagnosis and management of ischemic heart disease. This book is essentially designed to fill the vital gap existing between these practices, to provide a textbook that is substantial and readable, compact and reasonably comprehensive, and to provide an excellent blend of "basics to bedside and beyond" in the field of ischemic heart disease. The book also covers the future novel treatment strategies, focusing on the basic scientific and clinical aspects of the diagnosis and management of ischemic heart disease.