Understanding Clinical Data Analysis

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Understanding Clinical Data Analysis

Ton J. Cleophas,Aeilko H. Zwinderman
Understanding Clinical Data Analysis Book PDF

Author : Ton J. Cleophas,Aeilko H. Zwinderman
Publisher : Springer
Page : 234 pages
File Size : 51,5 Mb
Release : 2016-08-23
Category : Medical
ISBN : 9783319395869

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Understanding Clinical Data Analysis by Ton J. Cleophas,Aeilko H. Zwinderman Pdf

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.

Understanding Clinical Research

Renato D. Lopes,Robert A. Harrington
Understanding Clinical Research Book PDF

Author : Renato D. Lopes,Robert A. Harrington
Publisher : McGraw Hill Professional
Page : 272 pages
File Size : 48,6 Mb
Release : 2013-05-22
Category : Medical
ISBN : 9780071792653

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Understanding Clinical Research by Renato D. Lopes,Robert A. Harrington Pdf

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

Small Clinical Trials

Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
Small Clinical Trials Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
Publisher : National Academies Press
Page : 222 pages
File Size : 41,5 Mb
Release : 2001-01-01
Category : Medical
ISBN : 0309171148

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Small Clinical Trials by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials Pdf

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.

Fundamentals of Clinical Data Science

Pieter Kubben,Michel Dumontier,Andre Dekker
Fundamentals of Clinical Data Science Book PDF

Author : Pieter Kubben,Michel Dumontier,Andre Dekker
Publisher : Springer
Page : 219 pages
File Size : 41,5 Mb
Release : 2018-12-21
Category : Medical
ISBN : 9783319997131

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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.

Sharing Clinical Trial Data

Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Sharing Clinical Trial Data Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Publisher : National Academies Press
Page : 304 pages
File Size : 40,7 Mb
Release : 2015-04-20
Category : Medical
ISBN : 9780309316323

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Sharing Clinical Trial Data by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data Pdf

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.

Clinical Trial Data Analysis Using R

Ding-Geng (Din) Chen,Karl E. Peace
Clinical Trial Data Analysis Using R Book PDF

Author : Ding-Geng (Din) Chen,Karl E. Peace
Publisher : CRC Press
Page : 384 pages
File Size : 44,5 Mb
Release : 2010-12-14
Category : Mathematics
ISBN : 9781439840214

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Clinical Trial Data Analysis Using R by Ding-Geng (Din) Chen,Karl E. Peace Pdf

Too often in biostatistical research and clinical trials, a knowledge gap exists between developed statistical methods and the applications of these methods. Filling this gap, Clinical Trial Data Analysis Using R provides a thorough presentation of biostatistical analyses of clinical trial data and shows step by step how to implement the statistical methods using R. The book’s practical, detailed approach draws on the authors’ 30 years of real-world experience in biostatistical research and clinical development. Each chapter presents examples of clinical trials based on the authors’ actual experiences in clinical drug development. Various biostatistical methods for analyzing the data are then identified. The authors develop analysis code step by step using appropriate R packages and functions. This approach enables readers to gain an understanding of the analysis methods and R implementation so that they can use R to analyze their own clinical trial data. With step-by-step illustrations of R implementations, this book shows how to easily use R to simulate and analyze data from a clinical trial. It describes numerous up-to-date statistical methods and offers sound guidance on the processes involved in clinical trials.

Clinical Trial Data Analysis Using R and SAS

Ding-Geng (Din) Chen,Karl E. Peace,Pinggao Zhang
Clinical Trial Data Analysis Using R and SAS Book PDF

Author : Ding-Geng (Din) Chen,Karl E. Peace,Pinggao Zhang
Publisher : CRC Press
Page : 310 pages
File Size : 53,9 Mb
Release : 2017-06-01
Category : Mathematics
ISBN : 9781351651141

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Clinical Trial Data Analysis Using R and SAS by Ding-Geng (Din) Chen,Karl E. Peace,Pinggao Zhang Pdf

Review of the First Edition "The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods. Overall, this book achieves the goal successfully and does a nice job. I would highly recommend it ...The example-based approach is easy to follow and makes the book a very helpful desktop reference for many biostatistics methods."—Journal of Statistical Software Clinical Trial Data Analysis Using R and SAS, Second Edition provides a thorough presentation of biostatistical analyses of clinical trial data with step-by-step implementations using R and SAS. The book’s practical, detailed approach draws on the authors’ 30 years’ experience in biostatistical research and clinical development. The authors develop step-by-step analysis code using appropriate R packages and functions and SAS PROCS, which enables readers to gain an understanding of the analysis methods and R and SAS implementation so that they can use these two popular software packages to analyze their own clinical trial data. What’s New in the Second Edition Adds SAS programs along with the R programs for clinical trial data analysis. Updates all the statistical analysis with updated R packages. Includes correlated data analysis with multivariate analysis of variance. Applies R and SAS to clinical trial data from hypertension, duodenal ulcer, beta blockers, familial andenomatous polyposis, and breast cancer trials. Covers the biostatistical aspects of various clinical trials, including treatment comparisons, time-to-event endpoints, longitudinal clinical trials, and bioequivalence trials.

Statistics Applied to Clinical Trials

Ton J. Cleophas,A.H. Zwinderman
Statistics Applied to Clinical Trials Book PDF

Author : Ton J. Cleophas,A.H. Zwinderman
Publisher : Springer Science & Business Media
Page : 105 pages
File Size : 51,6 Mb
Release : 2013-11-11
Category : Medical
ISBN : 9789401595087

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Statistics Applied to Clinical Trials by Ton J. Cleophas,A.H. Zwinderman Pdf

In 1948 the first randomized controlled trial was published by the English Medical Research Council in the British Medical Journal. Until then, observations had been uncontrolled. Initially, trials frequently did not confirm the hypotheses to be tested. This phenomenon was attributed to low sensitivity due to small samples, as well as inappropriate hypotheses based on biased prior trials. Additional flaws were recognized and, subsequently, were better accounted for: carryover effects due to insufficient washout from previous treatments, time effects due to external factors and the natural history of the condition under study, bias due to asymmetry between treatment groups, lack of sensitivity due to a negative correlation between treatment responses, and so on. Such flaws, mainly of a technical nature, have been largely corrected and led to trials after 1970 being of significantly higher quality. The past decade has focused, in addition to technical aspects, on the need for circumspection in the planning and conducting of clinical trials. As a consequence, prior to approval, clinical trial protocols are now routinely scrutinized by different circumstantial organs, including ethics committees, institutional and federal review boards, national and international scientific organizations, and monitoring committees charged with conducting interim analyses. This book not only explains classical statistical analyses of clinical trials, but also addresses relatively novel issues, including equivalence testing, interim analyses, sequential analyses, and meta-analyses, and provides a framework of the best statistical methods currently available for such purposes. This book is not only useful for investigators involved in the field of clinical trials, but also for all physicians who wish to better understand the data of trials as currently published.

Understanding Clinical Research

Kathryn Biddle,Anna Blundell,Nidhi Sofat
Understanding Clinical Research Book PDF

Author : Kathryn Biddle,Anna Blundell,Nidhi Sofat
Publisher : Scion Publishing Ltd
Page : 202 pages
File Size : 48,8 Mb
Release : 2023-05-17
Category : Medical
ISBN : 9781914961311

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Understanding Clinical Research by Kathryn Biddle,Anna Blundell,Nidhi Sofat Pdf

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

The Prevention and Treatment of Missing Data in Clinical Trials

National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
The Prevention and Treatment of Missing Data in Clinical Trials Book PDF

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
Publisher : National Academies Press
Page : 163 pages
File Size : 50,8 Mb
Release : 2010-12-21
Category : Medical
ISBN : 9780309186513

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The Prevention and Treatment of Missing Data in Clinical Trials by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials Pdf

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.

The Role of Purchasers and Payers in the Clinical Research Enterprise

Institute of Medicine,Board on Health Sciences Policy,Clinical Research Roundtable
The Role of Purchasers and Payers in the Clinical Research Enterprise Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Clinical Research Roundtable
Publisher : National Academies Press
Page : 120 pages
File Size : 55,8 Mb
Release : 2002-06-14
Category : Medical
ISBN : 9780309182904

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The Role of Purchasers and Payers in the Clinical Research Enterprise by Institute of Medicine,Board on Health Sciences Policy,Clinical Research Roundtable Pdf

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 Trial Data Analysis Using R and SAS

Ding-Geng Chen,Karl E. Peace,Pinggao Zhang
Clinical Trial Data Analysis Using R and SAS Book PDF

Author : Ding-Geng Chen,Karl E. Peace,Pinggao Zhang
Publisher : CRC Press
Page : 378 pages
File Size : 49,8 Mb
Release : 2020-12-18
Category : Electronic
ISBN : 0367736217

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Clinical Trial Data Analysis Using R and SAS by Ding-Geng Chen,Karl E. Peace,Pinggao Zhang Pdf

Review of the First Edition "The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods. Overall, this book achieves the goal successfully and does a nice job. I would highly recommend it ...The example-based approach is easy to follow and makes the book a very helpful desktop reference for many biostatistics methods."--Journal of Statistical Software Clinical Trial Data Analysis Using R and SAS, Second Edition provides a thorough presentation of biostatistical analyses of clinical trial data with step-by-step implementations using R and SAS. The book's practical, detailed approach draws on the authors' 30 years' experience in biostatistical research and clinical development. The authors develop step-by-step analysis code using appropriate R packages and functions and SAS PROCS, which enables readers to gain an understanding of the analysis methods and R and SAS implementation so that they can use these two popular software packages to analyze their own clinical trial data. What's New in the Second Edition Adds SAS programs along with the R programs for clinical trial data analysis. Updates all the statistical analysis with updated R packages. Includes correlated data analysis with multivariate analysis of variance. Applies R and SAS to clinical trial data from hypertension, duodenal ulcer, beta blockers, familial andenomatous polyposis, and breast cancer trials. Covers the biostatistical aspects of various clinical trials, including treatment comparisons, time-to-event endpoints, longitudinal clinical trials, and bioequivalence trials.

Methods and Biostatistics in Oncology

Raphael. L.C Araújo,Rachel P. Riechelmann
Methods and Biostatistics in Oncology Book PDF

Author : Raphael. L.C Araújo,Rachel P. Riechelmann
Publisher : Springer
Page : 348 pages
File Size : 55,7 Mb
Release : 2018-04-16
Category : Medical
ISBN : 9783319713243

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Methods and Biostatistics in Oncology by Raphael. L.C Araújo,Rachel P. Riechelmann Pdf

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.

Strategy and Statistics in Clinical Trials

Joseph Tal
Strategy and Statistics in Clinical Trials Book PDF

Author : Joseph Tal
Publisher : Academic Press
Page : 279 pages
File Size : 50,5 Mb
Release : 2011-07-14
Category : Mathematics
ISBN : 9780123869098

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Strategy and Statistics in Clinical Trials by Joseph Tal Pdf

Delineates the statistical building blocks and concepts of clinical trials.

Designing Clinical Research

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

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 : 43,5 Mb
Release : 2011-11-30
Category : Medical
ISBN : 9781451165852

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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.