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This new edition covers important new trials in cardiology therapies and prevention of cardiovascular problems. The world authorities on pharmacologic clinical trials write about the trials, the outcomes and importance for clinical practice. This book gives the general cardiologist insight into the development of new therapies in cardiology as well as the process of how trials were used for those therapies. In addition to providing a manual for how to establish trials, trials for treatment and prevention are covered.
Book Synopsis Clinical Trials in Heart Disease by : JoAnn E. Manson
Download or read book Clinical Trials in Heart Disease written by JoAnn E. Manson and published by . This book was released on 2004 with total page 456 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition covers important new trials in cardiology therapies and prevention of cardiovascular problems. The world authorities on pharmacologic clinical trials write about the trials, the outcomes and importance for clinical practice. This book gives the general cardiologist insight into the development of new therapies in cardiology as well as the process of how trials were used for those therapies. In addition to providing a manual for how to establish trials, trials for treatment and prevention are covered.
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.
Book Synopsis Clinical Trials in Cardiology by : Bertram Pitt
Download or read book Clinical Trials in Cardiology written by Bertram Pitt and published by Bailliere Tindall Limited. This book was released on 1997 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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.
Book Synopsis Cardiovascular Disability by : Institute of Medicine
Download or read book Cardiovascular Disability written by Institute of Medicine and published by National Academies Press. This book was released on 2010-12-04 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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.
Book Synopsis Cardiovascular Clinical Trials by : Marcus Flather
Download or read book Cardiovascular Clinical Trials written by Marcus Flather and published by John Wiley & Sons. This book was released on 2012-12-03 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
Book Synopsis Small Clinical Trials by : Institute of Medicine
Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
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.
Book Synopsis 3D Echocardiography by : Takahiro Shiota
Download or read book 3D Echocardiography written by Takahiro Shiota and published by CRC Press. This book was released on 2020-12-29 with total page 621 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.
Book Synopsis Fundamentals of Clinical Trials by : Lawrence M. Friedman
Download or read book Fundamentals of Clinical Trials written by Lawrence M. Friedman and published by Springer Science & Business Media. This book was released on 1998 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.
Cardiovascular, respiratory, and related conditions cause more than 40 percent of all deaths globally, and their substantial burden is rising, particularly in low- and middle-income countries (LMICs). Their burden extends well beyond health effects to include significant economic and societal consequences. Most of these conditions are related, share risk factors, and have common control measures at the clinical, population, and policy levels. Lives can be extended and improved when these diseases are prevented, detected, and managed. This volume summarizes current knowledge and presents evidence-based interventions that are effective, cost-effective, and scalable in LMICs.
Book Synopsis Disease Control Priorities, Third Edition (Volume 5) by : Dorairaj Prabhakaran
Download or read book Disease Control Priorities, Third Edition (Volume 5) written by Dorairaj Prabhakaran and published by World Bank Publications. This book was released on 2017-11-17 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cardiovascular, respiratory, and related conditions cause more than 40 percent of all deaths globally, and their substantial burden is rising, particularly in low- and middle-income countries (LMICs). Their burden extends well beyond health effects to include significant economic and societal consequences. Most of these conditions are related, share risk factors, and have common control measures at the clinical, population, and policy levels. Lives can be extended and improved when these diseases are prevented, detected, and managed. This volume summarizes current knowledge and presents evidence-based interventions that are effective, cost-effective, and scalable in LMICs.
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.
Book Synopsis Practical Considerations for Adaptive Trial Design and Implementation by : Weili He
Download or read book Practical Considerations for Adaptive Trial Design and Implementation written by Weili He and published by Springer. This book was released on 2014-10-15 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Increasingly over the past five years, uncertainty about reimbursement for routine patient care has been suspected as contributing to problems enrolling people in clinical trials. Clinical trial investigators cannot guarantee that Medicare will pay for the care required, and they must disclose this uncertainty to potential participants during the informed consent process. Since Medicare does not routinely "preauthorize" care (as do many commercial insurers) the uncertainty cannot be dispelled in advance. Thus, patients considering whether to enter trials must assume that they may have to pay bills that Medicare rejects simply because they have enrolled in the trial. This report recommends an explicit policy for reimbursement of routine patient care costs in clinical trials. It further recommends that HCFA provide additional support for selected clinical trials, and that the government support the establishment of a national clinical trials registry. These policies (1) should assure that beneficiaries would not be denied coverage merely because they have volunteered to participate in a clinical trial; and (2) would not impose excessive administrative burdens on HCFA, its fiscal intermediaries and carriers, or investigators, providers, or participants in clinical trials. Explicit rules would have the added benefit of increasing the uniformity of reimbursement decisions made by Medicare fiscal intermediaries and carriers in different parts of the country. Greater uniformity would, in turn, decrease the uncertainty about reimbursement when providers and patients embark on a clinical trial.
Book Synopsis Extending Medicare Reimbursement in Clinical Trials by : Institute of Medicine
Download or read book Extending Medicare Reimbursement in Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2000-03-17 with total page 86 pages. Available in PDF, EPUB and Kindle. Book excerpt: Increasingly over the past five years, uncertainty about reimbursement for routine patient care has been suspected as contributing to problems enrolling people in clinical trials. Clinical trial investigators cannot guarantee that Medicare will pay for the care required, and they must disclose this uncertainty to potential participants during the informed consent process. Since Medicare does not routinely "preauthorize" care (as do many commercial insurers) the uncertainty cannot be dispelled in advance. Thus, patients considering whether to enter trials must assume that they may have to pay bills that Medicare rejects simply because they have enrolled in the trial. This report recommends an explicit policy for reimbursement of routine patient care costs in clinical trials. It further recommends that HCFA provide additional support for selected clinical trials, and that the government support the establishment of a national clinical trials registry. These policies (1) should assure that beneficiaries would not be denied coverage merely because they have volunteered to participate in a clinical trial; and (2) would not impose excessive administrative burdens on HCFA, its fiscal intermediaries and carriers, or investigators, providers, or participants in clinical trials. Explicit rules would have the added benefit of increasing the uniformity of reimbursement decisions made by Medicare fiscal intermediaries and carriers in different parts of the country. Greater uniformity would, in turn, decrease the uncertainty about reimbursement when providers and patients embark on a clinical trial.
