Clinical Trials in Neurology

Clinical Trials in Neurology PDF Author: Roberto J. Guiloff
Publisher: Springer Science & Business Media
ISBN: 1447137876
Category : Medical
Languages : en
Pages : 537

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Book Description
Clinical Trials in Neurology comprehensively tackles the methodology and design of clinical trials in neurological disease. A general section deals with the ethical aspects, drug development and regulatory requirements, basic trial designs and the statistics used. A diseases section tackles specific aspects of disorders, focusing on the relevant ethical issues, outcome variables and experience with large multicentre trials.

Clinical Trials in Neurology

Clinical Trials in Neurology PDF Author: Roberto J. Guiloff
Publisher: Springer Science & Business Media
ISBN: 1447137876
Category : Medical
Languages : en
Pages : 537

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Book Description
Clinical Trials in Neurology comprehensively tackles the methodology and design of clinical trials in neurological disease. A general section deals with the ethical aspects, drug development and regulatory requirements, basic trial designs and the statistics used. A diseases section tackles specific aspects of disorders, focusing on the relevant ethical issues, outcome variables and experience with large multicentre trials.

Methods in Clinical Trials in Neurology

Methods in Clinical Trials in Neurology PDF Author: Rudy Capildeo
Publisher:
ISBN: 9780333423059
Category : Central nervous system
Languages : en
Pages : 327

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Book Description


Methods in Clinical Trials in Neurology

Methods in Clinical Trials in Neurology PDF Author: Rudy Capildeo
Publisher: Springer
ISBN: 1349089435
Category : Medical
Languages : en
Pages : 324

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Book Description


Neuroscience Trials of the Future

Neuroscience Trials of the Future PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309442583
Category : Medical
Languages : en
Pages : 111

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Book Description
On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.

Controlled Clinical Trials in Neurological Disease

Controlled Clinical Trials in Neurological Disease PDF Author: Roger J. Porter
Publisher: Springer Science & Business Media
ISBN: 146131495X
Category : Medical
Languages : en
Pages : 447

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Book Description
The evaluation of the efficacy and safety of a clinical tool, be it a diagnostic technique, a preventive methodology, or a therapeutic intervention, is an im portant responsibility of physicians. The history of medicine is characterized by the authoritarianisms of teachers and of organizations giving way to the clinical experience of physicians; authoritarian dictum was replaced by case report and then by case series. As physicians learned to substitute the analysis of data for the inconsistencies of dictums and anecdotes, the problems of the case series as an investigative tool became more evident: patient selection criteria, measurements of outcome, significance of results, and extrapolation of conclusions to the community of patients. In response to these issues, the methodology of the controlled clinical trial has evolved and with it the instru ments of study design and of biostatistics as aids to study design and data analysis. The medical - surgical armamentarium has evolved from being dependent solely upon the observations and conclusions of a skilled clinician to being constructed upon the systematic collection and evaluation of data by a team of skilled clinicians and their statistical colleagues: this is the controlled clinical trial. During the past two decades, the evaluation of clinical approaches to pre vention and therapy has become particularly important to clinicians concerned with nervous system dysfunction. There has been and continues to be an explosion of information from the basic neurosciences and from the applica tion of biotechnology to the nervous system.

Clinical Trials in Neurology

Clinical Trials in Neurology PDF Author: Bernard Ravina
Publisher: Cambridge University Press
ISBN: 0521762596
Category : Medical
Languages : en
Pages : 387

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Book Description
Comprehensive book that suggests ways to improve the efficiency of clinical trials and the development of interventions in the neurosciences.

Magnetic Resonance Techniques in Clinical Trials in Multiple Sclerosis

Magnetic Resonance Techniques in Clinical Trials in Multiple Sclerosis PDF Author: M. Filippi
Publisher: Springer Science & Business Media
ISBN: 8847021537
Category : Medical
Languages : en
Pages : 200

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Book Description
We have entered an exciting period in the study of multiple sclerosis and its treatment. Central to this progress has been the introduction of magnetic reso nance techniques. When Young and his colleagues published the first images of the brain in multiple sclerosis at the end of 1981, it was at once obvious that magnetic resonance imaging would playa major role in diagnosis. Intuitively one felt that it would also have a role in increasing our understanding of the pathogenesis of the disease and in monitoring treatment. And so it has proved. Important problems however remain, perhaps the most important of which at present is the weak predictive power of standard magnetic resonance ima ging methods in determining the possibility of progression of impairment and disability. Recently, there have been advances which promise to overcome some of these problems, but decisions about what approach to adopt in selecting patients for clinical trials and which techniques to use in monitoring treatment during their course are still difficult. In this book, Dr. Filippi and his colleagues have assembled an outstanding group of contributors whose work is central to the progress that is being made. The coverage of the issues involved in the use of magnetic resonance techniques in assessing therapeutic effect is comprehensive and, though the field is chan ging rapidly, the principles and much of the detail in the book are likely to have lasting value.

Principles and Practice of Clinical Research

Principles and Practice of Clinical Research PDF Author: John I. Gallin
Publisher: Elsevier
ISBN: 0080489567
Category : Science
Languages : en
Pages : 447

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Book Description
The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government

Virtual Clinical Trials

Virtual Clinical Trials PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309494885
Category : Medical
Languages : en
Pages : 127

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Book Description
Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.

Sharing Clinical Trial Data

Sharing Clinical Trial Data PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236

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Book Description
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.