Fundamentals Of Clinical Trials

Fundamentals Of Clinical Trials Book in PDF, ePub and Kindle version is available to download in english. Read online anytime anywhere directly from your device. Click on the download button below to get a free pdf file of Fundamentals Of Clinical Trials book. This book definitely worth reading, it is an incredibly well-written.

Fundamentals of Clinical Trials

Author : Lawrence M. Friedman,Curt D. Furberg,David L. DeMets
Publisher : Springer Science & Business Media
Page : 445 pages
File Size : 53,5 Mb
Release : 2010-09-09
Category : Medical
ISBN : 9781441915863

Get Book

Fundamentals of Clinical Trials by Lawrence M. Friedman,Curt D. Furberg,David L. DeMets Pdf

The clinical trial is “the most definitive tool for evaluation of the applicability of clinical research.” It represents “a key research activity with the potential to improve the quality of health care and control costs through careful comparison of alternative treatments” [1]. It has been called on many occasions, “the gold st- dard” against which all other clinical research is measured. Although many clinical trials are of high quality, a careful reader of the medical literature will notice that a large number have deficiencies in design, conduct, analysis, presentation, and/or interpretation of results. Improvements have occurred over the past few decades, but too many trials are still conducted without adequate attention to its fundamental principles. Certainly, numerous studies could have been upgraded if the authors had had a better understanding of the fundamentals. Since the publication of the first edition of this book, a large number of other texts on clinical trials have appeared, most of which are indicated here [2–21]. Several of them, however, discuss only specific issues involved in clinical trials. Additionally, many are no longer current. The purpose of this fourth edition is to update areas in which major progress has been made since the publication of the third edition. We have revised most chapters considerably and added one on ethical issues.

Fundamentals of Clinical Trials

Author : Lawrence M. Friedman,Curt Furberg,David L. DeMets
Publisher : Springer Science & Business Media
Page : 384 pages
File Size : 45,9 Mb
Release : 1998
Category : Clinical trials
ISBN : 0387985867

Get Book

Fundamentals of Clinical Trials by Lawrence M. Friedman,Curt Furberg,David L. DeMets Pdf

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.

Essentials of Clinical Research

Author : Stephen P. Glasser
Publisher : Springer
Page : 461 pages
File Size : 47,9 Mb
Release : 2014-06-02
Category : Medical
ISBN : 9783319054704

Get Book

Essentials of Clinical Research by Stephen P. Glasser Pdf

In its extensively revised and updated Second Edition, this book provides a solid foundation for readers interested in clinical research. Discussion encompasses genetic, pharmacoepidemiologic and implementation research. All chapters have been updated with new information and many new tables have been added to elucidate key points. The book now offers discussion on how to handle missing data when analyzing results, and coverage of Adaptive Designs and Effectiveness Designs and new sections on Comparative Effectiveness Research and Pragmatic Trials. Chapter 6 includes new material on Phase 0 Trials, expanded coverage of Futility Trials, a discussion of Medical Device approval, Off Label Drug use and the role of the FDA in regulating advertising. Additional new information includes the role of pill color and shape in association with the placebo effect and an examination of issues surrounding minority recruitment. The final chapter offers a new section on manuscript preparation along with a discussion of various guidelines being adopted by journals: CONSORT, STROBE, PRISMA, MOOSE and others; and coverage of Conflicts of Interest, Authorship, Coercive Citation, and Disclosures in Industry-Related Associations. Building on the strengths of its predecessor in its comprehensive approach and authoritative advice, the new edition offers more of what has made this book a popular, trusted resource for students and working researchers alike.

The Fundamentals of Clinical Research

Author : P. Michael Dubinsky,Karen A. Henry
Publisher : John Wiley & Sons
Page : 554 pages
File Size : 40,9 Mb
Release : 2022-01-26
Category : Medical
ISBN : 9781118949597

Get Book

The Fundamentals of Clinical Research by P. Michael Dubinsky,Karen A. Henry Pdf

This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources

Clinical Trials

Author : Duolao Wang,Ameet Bakhai
Publisher : Remedica
Page : 497 pages
File Size : 55,9 Mb
Release : 2006
Category : Medical
ISBN : 9781901346725

Get Book

Clinical Trials by Duolao Wang,Ameet Bakhai Pdf

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.

Fundamentals of Clinical Data Science

Author : Pieter Kubben,Michel Dumontier,Andre Dekker
Publisher : Springer
Page : 219 pages
File Size : 43,6 Mb
Release : 2018-12-21
Category : Medical
ISBN : 9783319997131

Get Book

Fundamentals of Clinical Data Science by Pieter Kubben,Michel Dumontier,Andre Dekker Pdf

This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.

Principles and Practice of Clinical Trials

Author : Steven Piantadosi,Curtis L. Meinert
Publisher : Springer Nature
Page : 2573 pages
File Size : 55,8 Mb
Release : 2022-07-19
Category : Medical
ISBN : 9783319526362

Get Book

Principles and Practice of Clinical Trials by Steven Piantadosi,Curtis L. Meinert Pdf

This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

Textbook of Clinical Trials

Author : David Machin,Simon Day,Sylvan Green
Publisher : John Wiley & Sons
Page : 784 pages
File Size : 47,7 Mb
Release : 2007-01-11
Category : Mathematics
ISBN : 9780470010150

Get Book

Textbook of Clinical Trials by David Machin,Simon Day,Sylvan Green Pdf

Now published in its Second Edition, the Textbook of Clinical Trials offers detailed coverage of trial methodology in diverse areas of medicine in a single comprehensive volume. Praise for the First Edition: "... very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas." BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2, February 2005 The book’s main concept is to describe the impact of clinical trials on the practice of medicine. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. The sections provide a background to the disease area and general clinical trial methodology before concentrating on particular problems experienced in that area. Specific examples are used throughout to address these issues. The Textbook of Clinical Trials, Second Edition: Highlights the various ways clinical trials have influenced the practice of medicine in many therapeutic areas Describes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fields Additional therapeutic areas are included in this Second Edition to fill gaps in the First Edition as the number and complexity of trials increases in this rapidly developing area Newly covered or updated in the Second Edition: general surgery, plastic surgery, aesthetic surgery, palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal, thyroid and urological cancers, as well as a chapter on the Cochrane network An invaluable resource for pharmaceutical companies, the Textbook of Clinical Trials, Second Edition appeals to those working in contract research organizations, medical departments and in the area of public health and health science alike.

Multiple Analyses in Clinical Trials

Author : Lemuel A. Moyé
Publisher : Springer Science & Business Media
Page : 436 pages
File Size : 41,7 Mb
Release : 2006-05-17
Category : Medical
ISBN : 9780387218137

Get Book

Multiple Analyses in Clinical Trials by Lemuel A. Moyé Pdf

Concentrating on the rationale for the analyses, the difficulties posed by their interpretation, easily understood solutions, and useful problem sets, this book will help clinical investigators understand multiple analysis procedures and key issues. It is written for advanced medical students, clinical investigators at all levels, research groups within the pharmaceutical industry, regulators at the local, state, and federal level, and biostatisticians.

Clinical Trials

Author : Tom Brody
Publisher : Academic Press
Page : 897 pages
File Size : 42,9 Mb
Release : 2016-02-19
Category : Medical
ISBN : 9780128042588

Get Book

Clinical Trials by Tom Brody Pdf

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

A Practical Guide to Managing Clinical Trials

Author : JoAnn Pfeiffer,Cris Wells
Publisher : CRC Press
Page : 292 pages
File Size : 48,7 Mb
Release : 2017-05-18
Category : Mathematics
ISBN : 9781315299778

Get Book

A Practical Guide to Managing Clinical Trials by JoAnn Pfeiffer,Cris Wells Pdf

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.

Introduction to Statistical Methods for Clinical Trials

Author : Thomas D. Cook,David L DeMets
Publisher : CRC Press
Page : 465 pages
File Size : 42,5 Mb
Release : 2007-11-19
Category : Mathematics
ISBN : 9781584880271

Get Book

Introduction to Statistical Methods for Clinical Trials by Thomas D. Cook,David L DeMets Pdf

Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors’ collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various statistical topics relevant to the design, monitoring, and analysis of a clinical trial. After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals. Developed from a course taught at the University of Wisconsin for the past 25 years, this textbook provides a solid understanding of the statistical approaches used in the design, conduct, and analysis of clinical trials.

Critical Thinking in Clinical Research

Author : Felipe Fregni,Ben M. W. Illigens
Publisher : Oxford University Press
Page : 537 pages
File Size : 55,9 Mb
Release : 2018
Category : Medical
ISBN : 9780199324491

Get Book

Critical Thinking in Clinical Research by Felipe Fregni,Ben M. W. Illigens Pdf

Critical Thinking in Clinical Research explains the fundamentals of clinical research in a case-based approach. The core concept is to combine a clear and concise transfer of information and knowledge with an engagement of the reader to develop a mastery of learning and critical thinking skills. The book addresses the main concepts of clinical research, basics of biostatistics, advanced topics in applied biostatistics, and practical aspects of clinical research, with emphasis on clinical relevance across all medical specialties.

Designing Clinical Research

Author : Stephen B. Hulley,Steven R. Cummings,Warren S. Browner,Deborah G. Grady,Thomas B. Newman
Publisher : Lippincott Williams & Wilkins
Page : 388 pages
File Size : 41,7 Mb
Release : 2011-11-30
Category : Medical
ISBN : 9781451165852

Get Book

Designing Clinical Research by Stephen B. Hulley,Steven R. Cummings,Warren S. Browner,Deborah G. Grady,Thomas B. Newman Pdf

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.

ClinicalTrials

Author : Curtis L. Meinert
Publisher : OUP USA
Page : 702 pages
File Size : 40,8 Mb
Release : 2012-03-27
Category : Medical
ISBN : 9780195387889

Get Book

ClinicalTrials by Curtis L. Meinert Pdf

The classic, definitive guide to the design, conduct, and analysis of randomized clinical trials.