Understanding Clinical Research

Author : Renato D. Lopes
Publisher : McGraw Hill Professional
ISBN 13 : 0071792651
Total Pages : 262 pages
Book Rating : 4.53/5 ( download)

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Download or read book Understanding Clinical Research written by Renato D. Lopes and published by McGraw Hill Professional. This book was released on 2013-05-22 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309182905
Total Pages : 120 pages
Book Rating : 4.04/5 ( download)

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Download or read book The Role of Purchasers and Payers in the Clinical Research Enterprise written by Institute of Medicine and published by National Academies Press. This book was released on 2002-06-14 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective.

Author : Ton J. Cleophas
Publisher : Springer
ISBN 13 : 3319395866
Total Pages : 234 pages
Book Rating : 4.69/5 ( download)

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Download or read book Understanding Clinical Data Analysis written by Ton J. Cleophas and published by Springer. This book was released on 2016-08-23 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook consists of ten chapters, and is a must-read to all medical and health professionals, who already have basic knowledge of how to analyze their clinical data, but still, wonder, after having done so, why procedures were performed the way they were. The book is also a must-read to those who tend to submerge in the flood of novel statistical methodologies, as communicated in current clinical reports, and scientific meetings. In the past few years, the HOW-SO of current statistical tests has been made much more simple than it was in the past, thanks to the abundance of statistical software programs of an excellent quality. However, the WHY-SO may have been somewhat under-emphasized. For example, why do statistical tests constantly use unfamiliar terms, like probability distributions, hypothesis testing, randomness, normality, scientific rigor, and why are Gaussian curves so hard, and do they make non-mathematicians getting lost all the time? The book will cover the WHY-SOs.

Author : JoAnn Pfeiffer
Publisher : CRC Press
ISBN 13 : 1315299771
Total Pages : 292 pages
Book Rating : 4.78/5 ( download)

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Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by CRC Press. This book was released on 2017-05-18 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.

Author : Stephen B. Hulley
Publisher : Lippincott Williams & Wilkins
ISBN 13 : 1451165854
Total Pages : 388 pages
Book Rating : 4.52/5 ( download)

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Download or read book Designing Clinical Research written by Stephen B. Hulley and published by Lippincott Williams & Wilkins. This book was released on 2011-11-30 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 304 pages
Book Rating : 4.23/5 ( download)

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Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Kathryn Biddle
Publisher : Scion Publishing Ltd
ISBN 13 : 1914961315
Total Pages : 202 pages
Book Rating : 4.11/5 ( download)

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Download or read book Understanding Clinical Research written by Kathryn Biddle and published by Scion Publishing Ltd. This book was released on 2023-05-17 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is important for healthcare professionals to understand the basics of clinical research. This book offers a thorough explanation of the principles of clinical research, alongside a wide range of worked examples which show how these principles are applied in practice. Understanding Clinical Research takes readers from how to develop research questions, through the design of research studies, to disseminating research findings. Ethical considerations, research integrity, patient involvement, and study funding are all covered, along with an introduction to the key statistical methods needed for data analysis. Ideal for any healthcare professional: interested in understanding more about the development of evidence-based practice wanting to undertake research but not sure where to start considering or just starting a PhD / MD, or a PGCert in Research Studies

Author : Piers Page
Publisher : OUP Oxford
ISBN 13 : 0191629596
Total Pages : 224 pages
Book Rating : 4.94/5 ( download)

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Download or read book An Introduction to Clinical Research written by Piers Page and published by OUP Oxford. This book was released on 2011-11-10 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical book is written specifically for junior doctors by a team of highly experienced authors, as an introductory guide to clinical research. It covers all areas that a junior doctor needs to consider, including funding, study design, ethics, data analysis, disseminating findings, and furthering one's research career. It presents a balance view of clinical research and is written by authors actively involved in clinical research both at the 'coal-face' and at a more supervisory level. Research can be a difficult process and it is essential to make sure that the project is set up in the correct way in order to get verifiable results. This easy-to-read guide is available to help junior doctors develop a good study design and present evidence of a sound academic practice, which will make obtaining funding more likely and be time-efficient. Getting started early in research and developing a solid, gradual understanding of clinical research through using this approachable book will be of huge benefit to junior doctors and their discipline.

Author : Raphael. L.C Araújo
Publisher : Springer
ISBN 13 : 3319713248
Total Pages : 348 pages
Book Rating : 4.43/5 ( download)

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Download or read book Methods and Biostatistics in Oncology written by Raphael. L.C Araújo and published by Springer. This book was released on 2018-04-16 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book introduces and discusses the most important aspects of clinical research methods and biostatistics for oncologists, pursuing a tailor-made and practical approach. Evidence-based medicine (EBM) has been in vogue in the last few decades, particularly in rapidly advancing fields such as oncology. This approach has been used to support decision-making processes worldwide, sparking new clinical research and guidelines on clinical and surgical oncology. Clinical oncology research has many peculiarities, including specific study endpoints, a special focus on survival analyses, and a unique perspective on EBM. However, during medical studies and in general practice, these topics are barely taught. Moreover, even when EBM and clinical cancer research are discussed, they are presented in a theoretical fashion, mostly focused on formulas and numbers, rather than on clinical application for a proper literature appraisal. Addressing that gap, this book discusses more practical aspects of clinical research and biostatistics in oncology, instead of relying only on mathematical formulas and theoretical considerations. Methods and Biostatistics in Oncology will help readers develop the skills they need to understand the use of research on everyday oncology clinical practice for study design and interpretation, as well to demystify the use of EBM in oncology.

Author : R. Kay
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 1912776685
Total Pages : 110 pages
Book Rating : 4.89/5 ( download)

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Download or read book Fast Facts: Medical Statistics written by R. Kay and published by Karger Medical and Scientific Publishers. This book was released on 2020-07-17 with total page 110 pages. Available in PDF, EPUB and Kindle. Book excerpt: Using real examples from oncology trials, but keeping it simple, this concise resource explains the basic principles of medical statistics so that you can better appraise clinical trial results. Key concepts covered in this book include: • hypothesis testing • Kaplan–Meier curves and other graphic representations of data • calculating the power of a study • the stopping rules for efficacy and futility. ' Fast Facts: Medical Statistics' is aimed at all clinicians, clinical scientists, medical writers and regulatory personnel who need a better understanding of the statistical terms and methods used in the planning of studies and the analysis of clinical trial data. If you have ever wanted to know what a type I error is, how an odds ratio is calculated or what a forest plot is really all about, then this is the book for you. Contents: • Statistical inference • Analysis of time-to-event endpoints • Power and sample size • Multiplicity • Interim analysis • Modeling • Graphical methods