Statistical Evidence In Medical Trials

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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 : 221 pages
File Size : 52,6 Mb
Release : 2001-01-01
Category : Medical
ISBN : 9780309171144

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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.

Statistical Evidence in Medical Trials

Stephen D. Simon
Statistical Evidence in Medical Trials Book PDF

Author : Stephen D. Simon
Publisher : OUP Oxford
Page : 216 pages
File Size : 55,5 Mb
Release : 2006-02-23
Category : Medical
ISBN : 9780191588228

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Statistical Evidence in Medical Trials by Stephen D. Simon Pdf

Statistical Evidence in Medical Trials is a lucid, well-written and entertaining text that addresses common pitfalls in evaluating medical research. Including extensive use of publications from the medical literature and a non-technical account of how to appraise the quality of evidence presented in these publications, this book is ideal for health care professionals, students in medical or nursing schools, researchers and students in statistics, and anyone needing to assess the evidence published in medical journals. Stephen D. Simon earned a Ph.D. in statistics from the University of Iowa in 1982. He currently works as a research biostatistician at Children's Mercy Hospitals and Clinics in Kansas City, MO. He has authored or co-authored over 60 publications in a variety of medical and statistical journals, four of which have won awards. He has given a wide range of lectures and classes on statistics, evidence based medicine, research ethics, and quality control.

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 : 40,6 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.

Statistics Applied to Clinical Trials

Ton J. Cleophas,A.H. Zwinderman,Toine F. Cleophas,Eugene P. Cleophas
Statistics Applied to Clinical Trials Book PDF

Author : Ton J. Cleophas,A.H. Zwinderman,Toine F. Cleophas,Eugene P. Cleophas
Publisher : Springer Science & Business Media
Page : 550 pages
File Size : 45,8 Mb
Release : 2008-12-16
Category : Mathematics
ISBN : 9781402095238

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Statistics Applied to Clinical Trials by Ton J. Cleophas,A.H. Zwinderman,Toine F. Cleophas,Eugene P. Cleophas Pdf

In clinical medicine appropriate statistics has become indispensable to evaluate treatment effects. Randomized controlled trials are currently the only trials that truly provide evidence-based medicine. Evidence based medicine has become crucial to optimal treatment of patients. We can define randomized controlled trials by using Christopher J. Bulpitt’s definition “a carefully and ethically designed experiment which includes the provision of adequate and appropriate controls by a process of randomization, so that precisely framed questions can be answered”. The answers given by randomized controlled trials constitute at present the way how patients should be clinically managed. In the setup of such randomized trial one of the most important issues is the statistical basis. The randomized trial will never work when the statistical grounds and analyses have not been clearly defined beforehand. All endpoints should be clearly defined in order to perform appropriate power calculations. Based on these power calculations the exact number of available patients can be calculated in order to have a sufficient quantity of individuals to have the predefined questions answered. Therefore, every clinical physician should be capable to understand the statistical basis of well performed clinical trials. It is therefore a great pleasure that Drs. T. J. Cleophas, A. H. Zwinderman, and T. F. Cleophas have published a book on statistical analysis of clinical trials. The book entitled “Statistics Applied to Clinical Trials” is clearly written and makes complex issues in statistical analysis transparant.

Statistical Evidence in Medical Trials

Steve Simon
Statistical Evidence in Medical Trials Book PDF

Author : Steve Simon
Publisher : Unknown
Page : 0 pages
File Size : 42,8 Mb
Release : 2023
Category : Clinical trials
ISBN : 1383029768

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Statistical Evidence in Medical Trials by Steve Simon Pdf

Aimed at students and researchers in statistics and in the medical and health care sector as well as those who use and assess medical data, this work addresses common pitfalls in experimental design, focusing on the errors and misleading data that stem from flawed experiments and analytical methods in medical research.

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 : 43,9 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.

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 : 52,6 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.

Statistical Thinking in Clinical Trials

Michael A. Proschan
Statistical Thinking in Clinical Trials Book PDF

Author : Michael A. Proschan
Publisher : CRC Press
Page : 276 pages
File Size : 47,8 Mb
Release : 2021-11-24
Category : Mathematics
ISBN : 9781351673105

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Statistical Thinking in Clinical Trials by Michael A. Proschan Pdf

Statistical Thinking in Clinical Trials combines a relatively small number of key statistical principles and several instructive clinical trials to gently guide the reader through the statistical thinking needed in clinical trials. Randomization is the cornerstone of clinical trials and randomization-based inference is the cornerstone of this book. Read this book to learn the elegance and simplicity of re-randomization tests as the basis for statistical inference (the analyze as you randomize principle) and see how re-randomization tests can save a trial that required an unplanned, mid-course design change. Other principles enable the reader to quickly and confidently check calculations without relying on computer programs. The `EZ’ principle says that a single sample size formula can be applied to a multitude of statistical tests. The `O minus E except after V’ principle provides a simple estimator of the log odds ratio that is ideally suited for stratified analysis with a binary outcome. The same principle can be used to estimate the log hazard ratio and facilitate stratified analysis in a survival setting. Learn these and other simple techniques that will make you an invaluable clinical trial statistician.

Statistics Applied to Clinical Trials

Ton J. Cleophas,A.H. Zwinderman,Toine F. Cleophas,Eugene P. Cleophas
Statistics Applied to Clinical Trials Book PDF

Author : Ton J. Cleophas,A.H. Zwinderman,Toine F. Cleophas,Eugene P. Cleophas
Publisher : Springer
Page : 562 pages
File Size : 51,9 Mb
Release : 2009-08-29
Category : Mathematics
ISBN : 1402095341

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Statistics Applied to Clinical Trials by Ton J. Cleophas,A.H. Zwinderman,Toine F. Cleophas,Eugene P. Cleophas Pdf

In clinical medicine appropriate statistics has become indispensable to evaluate treatment effects. Randomized controlled trials are currently the only trials that truly provide evidence-based medicine. Evidence based medicine has become crucial to optimal treatment of patients. We can define randomized controlled trials by using Christopher J. Bulpitt’s definition “a carefully and ethically designed experiment which includes the provision of adequate and appropriate controls by a process of randomization, so that precisely framed questions can be answered”. The answers given by randomized controlled trials constitute at present the way how patients should be clinically managed. In the setup of such randomized trial one of the most important issues is the statistical basis. The randomized trial will never work when the statistical grounds and analyses have not been clearly defined beforehand. All endpoints should be clearly defined in order to perform appropriate power calculations. Based on these power calculations the exact number of available patients can be calculated in order to have a sufficient quantity of individuals to have the predefined questions answered. Therefore, every clinical physician should be capable to understand the statistical basis of well performed clinical trials. It is therefore a great pleasure that Drs. T. J. Cleophas, A. H. Zwinderman, and T. F. Cleophas have published a book on statistical analysis of clinical trials. The book entitled “Statistics Applied to Clinical Trials” is clearly written and makes complex issues in statistical analysis transparant.

Statistics Workbook for Evidence-based Health Care

Jennifer Peat,Belinda Barton,Elizabeth Elliott
Statistics Workbook for Evidence based Health Care Book PDF

Author : Jennifer Peat,Belinda Barton,Elizabeth Elliott
Publisher : John Wiley & Sons
Page : 192 pages
File Size : 54,8 Mb
Release : 2009-01-22
Category : Medical
ISBN : 9781444300505

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Statistics Workbook for Evidence-based Health Care by Jennifer Peat,Belinda Barton,Elizabeth Elliott Pdf

This concise, easy to understand and learner-friendly book invitesthe readers to actively particpate in the understanding of medicalstatistical concepts that are frequently used in health careresearch and evidence-based practice worldwide. Knowing that the best way to learn statistical concepts is touse them, the authors employ real examples and articles from healthscience literature, complete with the complexities that real lifepresents, in an approach that will help bring researchers andclinicians one step closer towards being statistical savvy andbetter able to critically read research literature and interpretthe results. A practical hands-on workbook for individual or groupexercises Teaches how to understand statistical methods when readingjournals, and how to use them in clinical research Emphasizes the use of statistics in evidence-basedresearch Relevant for anyone needing to use statistics, this workbook isan ideal resource for all health care professionals and students,especially those learning and practising evidence-basedmedicine.

Real-World Evidence in Drug Development and Evaluation

Harry Yang,Binbing Yu
Real World Evidence in Drug Development and Evaluation Book PDF

Author : Harry Yang,Binbing Yu
Publisher : CRC Press
Page : 191 pages
File Size : 49,9 Mb
Release : 2021-01-11
Category : Mathematics
ISBN : 9780429676826

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Real-World Evidence in Drug Development and Evaluation by Harry Yang,Binbing Yu Pdf

Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise

Design of Experiments and Advanced Statistical Techniques in Clinical Research

Basavarajaiah D. M.,Bhamidipati Narasimha Murthy
Design of Experiments and Advanced Statistical Techniques in Clinical Research Book PDF

Author : Basavarajaiah D. M.,Bhamidipati Narasimha Murthy
Publisher : Springer Nature
Page : 380 pages
File Size : 47,9 Mb
Release : 2020-11-05
Category : Medical
ISBN : 9789811582103

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Design of Experiments and Advanced Statistical Techniques in Clinical Research by Basavarajaiah D. M.,Bhamidipati Narasimha Murthy Pdf

Recent Statistical techniques are one of the basal evidence for clinical research, a pivotal in handling new clinical research and in evaluating and applying prior research. This book explores various choices of statistical tools and mechanisms, analyses of the associations among different clinical attributes. It uses advanced statistical methods to describe real clinical data sets, when the clinical processes being examined are still in the process. This book also discusses distinct methods for building predictive and probability distribution models in clinical situations and ways to assess the stability of these models and other quantitative conclusions drawn by realistic experimental data sets. Design of experiments and recent posthoc tests have been used in comparing treatment effects and precision of the experimentation. This book also facilitates clinicians towards understanding statistics and enabling them to follow and evaluate the real empirical studies (formulation of randomized control trial) that pledge insight evidence base for clinical practices. This book will be a useful resource for clinicians, postgraduates scholars in medicines, clinical research beginners and academicians to nurture high-level statistical tools with extensive scope.

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 : 221 pages
File Size : 47,7 Mb
Release : 2001-02-01
Category : Medical
ISBN : 9780309073332

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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.

Statistics Toolkit

Rafael Perera,Carl Heneghan,Douglas Badenoch
Statistics Toolkit Book PDF

Author : Rafael Perera,Carl Heneghan,Douglas Badenoch
Publisher : John Wiley & Sons
Page : 128 pages
File Size : 52,8 Mb
Release : 2011-09-23
Category : Medical
ISBN : 9781444358490

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Statistics Toolkit by Rafael Perera,Carl Heneghan,Douglas Badenoch Pdf

This concise book will help you to interpret the statistical evidence provided by quantitative studies and to plan how to work with data in your own clinical research. Following the successful format of the Toolkit series, Statistics Toolkit guides the reader through statistical concepts using flowcharts, diagrams and real life examples to reflect concepts in a simple and practical manner. Sections include: Clear explanation of basic concepts in the context of clinical research Demonstration of how data are described, displayed and interpreted in different formats Practical glossary and key to the symbols used in statistics and a discussion of the software tools The book offers a handy, quick reference that has an easy-to-follow structure throughout, making it ideal for health care professionals and students.

Finding What Works in Health Care

Institute of Medicine,Board on Health Care Services,Committee on Standards for Systematic Reviews of Comparative Effectiveness Research
Finding What Works in Health Care Book PDF

Author : Institute of Medicine,Board on Health Care Services,Committee on Standards for Systematic Reviews of Comparative Effectiveness Research
Publisher : National Academies Press
Page : 267 pages
File Size : 44,6 Mb
Release : 2011-06-20
Category : Medical
ISBN : 9780309216715

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Finding What Works in Health Care by Institute of Medicine,Board on Health Care Services,Committee on Standards for Systematic Reviews of Comparative Effectiveness Research Pdf

Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.