Understanding Clinical Investigations

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Publisher : Elsevier Health Sciences
ISBN 13 : 0702026832
Total Pages : 344 pages
Book Rating : 4.7/5 (2 download)

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Book Synopsis Understanding Clinical Investigations by : Susan Skinner

Download or read book Understanding Clinical Investigations written by Susan Skinner and published by Elsevier Health Sciences. This book was released on 2005-06-02 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: This indispensable handbook provides easily accessible explanations of the common investigations carried out on all body systems. It addresses the relationship between normal physiology and disease processes and the place of clinical investigation within these events. The rationale for investigation is made clear and some guidance for further care is offered. In this new edition each investigation has been updated in line in the light of recent guidelines and practice. New material has been added including chromosome studies and blood cholesterol values. Designed to give quickly referenced guidance on a broad spectrum of clinical investigation and monitoring, it will be helpful to all nursing staff and will assist in giving explaining tests to patients. Comprehensive range of common clinical investigations Combines normal physiology and clinical investigations and pathophysiology Appendix of normal values New design and format Each investigation has been updated in line in the light of recent guidelines and practice. New material has been added including chromosome studies and blood cholesterol values

Understanding Clinical Research

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Author :
Publisher : McGraw Hill Professional
ISBN 13 : 0071792651
Total Pages : 262 pages
Book Rating : 4.0/5 (717 download)

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Book Synopsis Understanding Clinical Research by : Renato D. Lopes

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

Fundamentals of Clinical Trials

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 9780387985862
Total Pages : 384 pages
Book Rating : 4.9/5 (858 download)

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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.

A Practical Guide to Managing Clinical Trials

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Publisher : CRC Press
ISBN 13 : 1315299771
Total Pages : 292 pages
Book Rating : 4.3/5 (152 download)

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Book Synopsis A Practical Guide to Managing Clinical Trials by : JoAnn Pfeiffer

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.

Clinical Trials

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Publisher : Academic Press
ISBN 13 : 0128042583
Total Pages : 897 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Clinical Trials by : Tom Brody

Download or read book Clinical Trials written by Tom Brody and published by Academic Press. This book was released on 2016-02-19 with total page 897 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. - Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more - Extensively covers the "study schema" and related features of study design - Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials - Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers

Understanding Clinical Data Analysis

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Author :
Publisher : Springer
ISBN 13 : 3319395866
Total Pages : 241 pages
Book Rating : 4.3/5 (193 download)

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Book Synopsis Understanding Clinical Data Analysis by : Ton J. Cleophas

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 241 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.

Principles and Practice of Clinical Research

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Author :
Publisher : Elsevier
ISBN 13 : 0080489567
Total Pages : 447 pages
Book Rating : 4.0/5 (84 download)

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Book Synopsis Principles and Practice of Clinical Research by : John I. Gallin

Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Elsevier. This book was released on 2011-04-28 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Clinical Investigations at a Glance

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 111875932X
Total Pages : 387 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis Clinical Investigations at a Glance by : Jonathan Gleadle

Download or read book Clinical Investigations at a Glance written by Jonathan Gleadle and published by John Wiley & Sons. This book was released on 2017-01-17 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Investigations at a Glance The market-leading at a Glance series is popular among healthcare students and newly qualified practitioners, for its concise and simple approach and excellent illustrations. Each bite-sized chapter is covered in a double-page spread with clear, easy-to-follow diagrams, supported by succinct explanatory text. Covering a wide range of topics, books in the at a Glance series are ideal as introductory texts for teaching, learning and revision, and are useful throughout university and beyond. Everything you need to know about Clinical Investigations... at a Glance! Clinical Investigations at a Glance provides an up-to-date, evidence-based overview of diagnostic investigations, looking at their choice, importance and interpretation for commonly presenting symptoms and conditions. Designed to help develop the evidence-based use of investigations and interpret results properly, the book provides a unique perspective on many critical issues in medical testing, with the aim of improving diagnostic accuracy and reducing unnecessary tests or harm. Clinical Investigations at a Glance is structured in three parts: an overview of tests; common presentations (such as chest pain, nausea and vomiting, weight loss and anaemia); and conditions organized by body system, such as cardiovascular disease, respiratory disease and nephrology. Key features include: How to interpret investigations, using high quality illustrations to compare ‘normal’ and ‘diseased’ results Evidence-based, including references How to select the most appropriate investigation, the accuracy of tests and how to manage incidental findings For more information on the complete range of Wiley medical student and junior doctor publishing, please visit: www.wileymedicaleducation.com To receive automatic updates on Wiley books and journals, join our email list. Sign up today at www.wiley.com/email All content reviewed by students for students Wiley Medical Education books are designed exactly for their intended audience. All of our books are developed in collaboration with students. This means that our books are always published with you, the student, in mind. If you would like to be one of our student reviewers, go to www.reviewmedicalbooks.com to find out more. This title is also available as an e-book. For more details, please see www.wiIey.com/buy/9781118759325

Designing Clinical Research

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Publisher : Lippincott Williams & Wilkins
ISBN 13 : 1451165854
Total Pages : 388 pages
Book Rating : 4.4/5 (511 download)

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Book Synopsis Designing Clinical Research by : Stephen B. Hulley

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.

Understanding Clinical Papers

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 0470091312
Total Pages : 247 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis Understanding Clinical Papers by : David Bowers

Download or read book Understanding Clinical Papers written by David Bowers and published by John Wiley & Sons. This book was released on 2006-05-01 with total page 247 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now in its Second Edition, this book helps to unravel the processof evidence-based practice, which requires clinicians to evaluateand collate information from the journals they read.Understanding Clinical Papers, SecondEdition uses actual papers to illustrate how tounderstand and evaluate published research, but goes beyond this toprovide an explanation of a range of important research-relatedtopics. Understanding Clinical Papers, Second Edition: Covers everything necessary to understand a clinical researchpaper Examples are illustrated and based uniquely on tables,abstracts and exerts from published clinical research papers Amazingly clear, lively, accessible style The new edition has been markedly improved and extended,containing, for example, new material on measurement scales,systematic reviews, writing a paper, statistics software andcritical appraisal “What strikes the reader... straight away isclarity… promises to become a recommended text forundergraduate and postgraduate courses." JOURNAL OF TROPICALPEDIATRICS “The writing style is amazingly clear and does notrequire formal course work in biostatistics orepidemiology…We strongly recommend it for beginners and foreasy entry into a complex domain and to experts who we think willenjoy it and who will find it useful as they teach, advise and helpothers.” QUALITY IN HEALTH CARE “What makes this book unique is that each pointpresented is illustrated with excerpts from actual papers, oftenthree or four per chapter... this is a very effective teachingdevice." JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION “This book should be an essential addition to thepersonal libraries of all health care workers who need to usearticles in journals. In these days of evidence-based medicine,this should apply to all physicians, nurses and other healthprofessionals.” ONCOLOGY Understanding Clinical Papers, Second Edition isan invaluable resource for everyone involved directly or indirectlyin health care – an ultimate guide for those who readclinical literature.

The Prevention and Treatment of Missing Data in Clinical Trials

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Author :
Publisher : National Academies Press
ISBN 13 : 030918651X
Total Pages : 163 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Prevention and Treatment of Missing Data in Clinical Trials by : National Research Council

Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Sharing Clinical Trial Data

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Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine

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 236 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.

The Role of Purchasers and Payers in the Clinical Research Enterprise

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Author :
Publisher : National Academies Press
ISBN 13 : 0309182905
Total Pages : 120 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Role of Purchasers and Payers in the Clinical Research Enterprise by : Institute of Medicine

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.

Clinical Trials

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Publisher : Remedica
ISBN 13 : 1901346722
Total Pages : 497 pages
Book Rating : 4.9/5 (13 download)

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Book Synopsis Clinical Trials by : Duolao Wang

Download or read book Clinical Trials written by Duolao Wang and published by Remedica. This book was released on 2006 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains statistics specifically for a medically literate audience. Readers gain not only an understanding of the basics of medical statistics, but also a critical insight into how to review and evaluate clinical trial evidence.

Clinical Trials and Human Research

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Author :
Publisher : Jossey-Bass
ISBN 13 : 9780787965709
Total Pages : 0 pages
Book Rating : 4.9/5 (657 download)

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Book Synopsis Clinical Trials and Human Research by : Fay A. Rozovsky

Download or read book Clinical Trials and Human Research written by Fay A. Rozovsky and published by Jossey-Bass. This book was released on 2003-06-10 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional Review Board, it offers timely and useful strategies for achieving regulatory compliance while reducing liability. In addition, insurance, quality management, accreditation, and risk management are topics examined in the book. The practical insights found in this volume are not found in other books on the subject. Clinical Trials and Human Research is a practical tool to help anyone involved in clinical research.

Clinical Research Computing

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Publisher : Academic Press
ISBN 13 : 012803145X
Total Pages : 242 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Clinical Research Computing by : Prakash Nadkarni

Download or read book Clinical Research Computing written by Prakash Nadkarni and published by Academic Press. This book was released on 2016-04-29 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Research Computing: A Practitioner's Handbook deals with the nuts-and-bolts of providing informatics and computing support for clinical research. The subjects that the practitioner must be aware of are not only technological and scientific, but also organizational and managerial. Therefore, the author offers case studies based on real life experiences in order to prepare the readers for the challenges they may face during their experiences either supporting clinical research or supporting electronic record systems. Clinical research computing is the application of computational methods to the broad field of clinical research. With the advent of modern digital computing, and the powerful data collection, storage, and analysis that is possible with it, it becomes more relevant to understand the technical details in order to fully seize its opportunities. - Offers case studies, based on real-life examples where possible, to engage the readers with more complex examples - Provides studies backed by technical details, e.g., schema diagrams, code snippets or algorithms illustrating particular techniques, to give the readers confidence to employ the techniques described in their own settings - Offers didactic content organization and an increasing complexity through the chapters

Strategy and Statistics in Clinical Trials

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Author :
Publisher : Academic Press
ISBN 13 : 0123869099
Total Pages : 279 pages
Book Rating : 4.1/5 (238 download)

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Book Synopsis Strategy and Statistics in Clinical Trials by : Joseph Tal

Download or read book Strategy and Statistics in Clinical Trials written by Joseph Tal and published by Academic Press. This book was released on 2011-07-14 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: Delineates the statistical building blocks and concepts of clinical trials.