Recent Advances In Clinical Trial Design And Analysis

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Recent Advances in Clinical Trial Design and Analysis

Peter F. Thall
Recent Advances in Clinical Trial Design and Analysis Book PDF

Author : Peter F. Thall
Publisher : Springer Science & Business Media
Page : 263 pages
File Size : 43,7 Mb
Release : 2012-12-06
Category : Medical
ISBN : 9781461520092

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Recent Advances in Clinical Trial Design and Analysis by Peter F. Thall Pdf

Clinical trials have two purposes -- to treat the patients in the trial, and to obtain information which increases our understanding of the disease and especially how patients respond to treatment. Statistical design provides a means to achieve both these aims, while statistical data analysis provides methods for extracting useful information from the trial data. Recent advances in statistical computing have enabled statisticians to implement very rapidly a broad array of methods which previously were either impractical or impossible. Biostatisticians are now able to provide much greater support to medical researchers working in both clinical and laboratory settings. As our collective toolkit of techniques for analyzing data has grown, it has become increasingly difficult for biostatisticians to keep up with all the developments in our own field. Recent Advances in Clinical Trial Design and Analysis brings together biostatisticians doing cutting-edge research and explains some of the more recent developments in biostatistics to clinicians and scientists who work in clinical 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 : 49,5 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.

Neuroscience Trials of the Future

National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Neuroscience Trials of the Future Book PDF

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Publisher : National Academies Press
Page : 111 pages
File Size : 47,8 Mb
Release : 2016-11-07
Category : Medical
ISBN : 9780309442589

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Neuroscience Trials of the Future by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Pdf

On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.

Randomised Clinical Trials

David Machin,Peter M. Fayers,Bee Choo Tai
Randomised Clinical Trials Book PDF

Author : David Machin,Peter M. Fayers,Bee Choo Tai
Publisher : John Wiley & Sons
Page : 86 pages
File Size : 43,6 Mb
Release : 2021-07-26
Category : Medical
ISBN : 9781119524649

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Randomised Clinical Trials by David Machin,Peter M. Fayers,Bee Choo Tai Pdf

Randomised Clinical Trials: Design, Practice and Reporting provides a detailed overview of the methodology for conducting clinical trials, including developing protocols, data capture, randomisation, analysis and reporting. Assuming no prior background, this user-friendly resource describes the statistical, regulatory, and practical components required for conducting randomised clinical trials. Numerous examples and case studies from industry, academia, and the research literature help readers understand each stage of the clinical trial process. This second edition contains extensively revised material throughout, including new chapters covering designs for repeated measures, non-inferiority, cluster and stepped wedge trials. Other new chapters describe data and safety monitoring, biomarker studies, and feasibility studies. Updated and expanded sections discuss situations where multiple organs, different body locations or competing risks are involved, subgroup analysis, and multiple outcomes. Written by an author team with extensive experience in conducting clinical trials, this book: Provides comprehensive coverage of randomised clinical trials, ranging from basic to advanced Features several new chapters, updated case studies and examples, and references to changes in regulations Explains basic randomised trials, including the parallel two-group controlled trial with a single outcome measure Covers paired trial designs and trials with more than two interventions Includes a chapter on miscellaneous topics such as adaptive designs, large simple trials, Bayesian methods for very small trials, alpha-spending functions and the predictive probability test Randomised Clinical Trials is essential reading for clinicians, nurses, data managers, and medical statisticians involved in clinical trials, and for health practitioners responsible for direct patient care in a clinical trial setting.

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 : 45,9 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.

Re-Engineering Clinical Trials

Peter Schueler,Brendan Buckley
Re Engineering Clinical Trials Book PDF

Author : Peter Schueler,Brendan Buckley
Publisher : Academic Press
Page : 360 pages
File Size : 41,5 Mb
Release : 2014-12-16
Category : Medical
ISBN : 9780128007907

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Re-Engineering Clinical Trials by Peter Schueler,Brendan Buckley Pdf

The pharmaceutical industry is currently operating under a business model that is not sustainable for the future. Given the high costs associated with drug development, there is a vital need to reform this process in order to provide safe and effective drugs while still securing a profit. Re-Engineering Clinical Trials evaluates the trends and challenges associated with the current drug development process and presents solutions that integrate the use of modern communication technologies, innovations and novel enrichment designs. This book focuses on the need to simplify drug development and offers you well-established methodologies and best practices based on real-world experiences from expert authors across industry and academia. Written for all those involved in clinical research, development and clinical trial design, this book provides a unique and valuable resource for streamlining the process, containing costs and increasing drug safety and effectiveness. Highlights the latest paradigm-shifts and innovation advances in clinical research Offers easy-to-find best practice sections, lists of current literature and resources for further reading and useful solutions to day-to-day problems in current drug development Discusses important topics such as safety profiling, data mining, site monitoring, change management, increasing development costs, key performance indicators and much more

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 : 46,5 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.

Design and Analysis of Clinical Trials

Shein-Chung Chow,Jen-Pei Liu
Design and Analysis of Clinical Trials Book PDF

Author : Shein-Chung Chow,Jen-Pei Liu
Publisher : Wiley-Interscience
Page : 680 pages
File Size : 50,9 Mb
Release : 1998-06-23
Category : Mathematics
ISBN : UOM:39015047055416

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Design and Analysis of Clinical Trials by Shein-Chung Chow,Jen-Pei Liu Pdf

A unique, unifying treatment for statistics and science in clinical trials What sets this volume apart from the many books dealing with clinical trials is its integration of statistical and clinical disciplines. Stressing communication between biostatisticians and clinical scientists, this work clearly relates statistical interpretation to clinical issues arising in different stages of pharmaceutical research and development. Plus, the principles presented here are universal enough to be easily adapted in non-biopharmaceutical settings. Design and Analysis of Clinical Trials tackles concepts and methodologies. It not only covers statistical basics such as uncertainty and bias, design considerations such as patient selection, randomization, and the different types of clinical trials but also deals with various methods of data analysis, group sequential procedures for interim analysis, efficacy data evaluation, analysis of safety data, and more. Throughout, the book: * Surveys current and emerging clinical issues and newly developed statistical methods * Presents a critical review of statistical methodologies in various therapeutic areas * Features case studies from actual clinical trials * Minimizes the mathematics involved, making the material widely accessible * Offers each chapter as a self-contained entity * Includes illustrations to highlight the text This monumental reference on all facets of clinical trials is important reading for physicians, clinical and medical researchers, pharmaceutical scientists, clinical programmers, biostatisticians, and anyone involved in this burgeoning area of clinical research. It can also be used as a textbook in graduate-level courses in the field.

Clinical Trial Design Challenges in Mood Disorders

Mauricio Tohen,Charles Bowden,Andrew A. Nierenberg,John Geddes
Clinical Trial Design Challenges in Mood Disorders Book PDF

Author : Mauricio Tohen,Charles Bowden,Andrew A. Nierenberg,John Geddes
Publisher : Academic Press
Page : 192 pages
File Size : 46,5 Mb
Release : 2015-01-24
Category : Medical
ISBN : 9780124051768

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Clinical Trial Design Challenges in Mood Disorders by Mauricio Tohen,Charles Bowden,Andrew A. Nierenberg,John Geddes Pdf

Poor clinical trial designs result in failed studies wasting research funds and limiting the advancement of cures for disorders. Clinical Trial Design Challenges in Mood Disorders outlines classic problems researchers face in designing clinical trials and discusses how best to address them for the most definitive and generalizable results. Traditional trial designs are included as well as novel analytic techniques. The book examines information on high placebo response, the generalizability of studies conducted in the developing world, the duration of maintenance studies, and the application of findings into clinical practice. With representation from contributors throughout the world and from academia, industry, regulatory agencies, and advocacy groups, this book will contribute toward improved clinical trial design and valid, precise, and reliable answers about what works better and faster for patients. Summarizes common trial design problems and their solutions Encompasses funding, subject selection, regulatory issues and more Identifies best practices for definitive and generalizable results Includes traditional trial designs and novel analytic techniques Represents academia, industry, regulatory agencies, and advocacy groups

Design and Analysis of Clinical Trials

Shein-Chung Chow,Jen-Pei Liu
Design and Analysis of Clinical Trials Book PDF

Author : Shein-Chung Chow,Jen-Pei Liu
Publisher : John Wiley & Sons
Page : 754 pages
File Size : 40,5 Mb
Release : 2008-12-04
Category : Mathematics
ISBN : 9780471473299

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Design and Analysis of Clinical Trials by Shein-Chung Chow,Jen-Pei Liu Pdf

Praise for the First Edition of Design and Analysis of Clinical Trials "An excellent book, providing a discussion of the clinical trial process from designing the study through analyzing the data, and to regulatory requirement . . . could easily be used as a classroom text to understand the process in the new drug development area." –Statistical Methods in Medicine A complete and balanced presentation now revised, updated, and expanded As the field of research possibilities expands, the need for a working understanding of how to carry out clinical trials only increases. New developments in the theory and practice of clinical research include a growing body of literature on the subject, new technologies and methodologies, and new guidelines from the International Conference on Harmonization (ICH). Design and Analysis of Clinical Trials, Second Edition provides both a comprehensive, unified presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. This unique resource bridges the gap between clinical and statistical disciplines, covering both fields in a lucid and accessible manner. Thoroughly updated from its first edition, the Second Edition of Design and Analysis of Clinical Trials features new topics such as: Clinical trials and regulations, especially those of the ICH Clinical significance, reproducibility, and generalizability Goals of clinical trials and target population New study designs and trial types Sample size determination on equivalence and noninferiority trials, as well as comparing variabilities Also, three entirely new chapters cover: Designs for cancer clinical trials Preparation and implementation of a clinical protocol Data management of a clinical trial Written with the practitioner in mind, the presentation assumes only a minimal mathematical and statistical background for its reader. Instead, the writing emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references-280 of them new to the Second Edition-to the literature. Design and Analysis of Clinical Trials, Second Edition will benefit academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students in these areas by serving as a useful, thorough reference source for clinical research.

Clinical Trials

Duolao Wang,Ameet Bakhai
Clinical Trials Book PDF

Author : Duolao Wang,Ameet Bakhai
Publisher : Remedica
Page : 497 pages
File Size : 44,6 Mb
Release : 2006
Category : Medical
ISBN : 9781901346725

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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.

Design and Analysis of Clinical Trials with Time-to-Event Endpoints

Karl E. Peace
Design and Analysis of Clinical Trials with Time to Event Endpoints Book PDF

Author : Karl E. Peace
Publisher : CRC Press
Page : 616 pages
File Size : 55,9 Mb
Release : 2009-04-23
Category : Mathematics
ISBN : 9781420066401

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Design and Analysis of Clinical Trials with Time-to-Event Endpoints by Karl E. Peace Pdf

Using time-to-event analysis methodology requires careful definition of the event, censored observation, provision of adequate follow-up, number of events, and independence or "noninformativeness" of the censoring mechanisms relative to the event. Design and Analysis of Clinical Trials with Time-to-Event Endpoints provides a thorough presentation of the design, monitoring, analysis, and interpretation of clinical trials in which time-to-event is of critical interest. After reviewing time-to-event endpoint methodology, clinical trial issues, and the design and monitoring of clinical trials, the book focuses on inferential analysis methods, including parametric, semiparametric, categorical, and Bayesian methods; an alternative to the Cox model for small samples; and estimation and testing for change in hazard. It then presents descriptive and graphical methods useful in the analysis of time-to-event endpoints. The next several chapters explore a variety of clinical trials, from analgesic, antibiotic, and antiviral trials to cardiovascular and cancer prevention, prostate cancer, astrocytoma brain tumor, and chronic myelogonous leukemia trials. The book then covers areas of drug development, medical practice, and safety assessment. It concludes with the design and analysis of clinical trials of animals required by the FDA for new drug applications. Drawing on the expert contributors’ experiences working in biomedical research and clinical drug development, this comprehensive resource covers an array of time-to-event methods and explores an assortment of real-world applications.

Management of Data in Clinical Trials

Eleanor McFadden
Management of Data in Clinical Trials Book PDF

Author : Eleanor McFadden
Publisher : John Wiley & Sons
Page : 206 pages
File Size : 49,9 Mb
Release : 2007-12-14
Category : Mathematics
ISBN : 9780470181270

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Management of Data in Clinical Trials by Eleanor McFadden Pdf

A valuable new edition of the trusted, practical guide to managing data in clinical trials Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided. While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements. Newly featured topics include: The growing availability of "off-the-shelf" solutions for clinical trials Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry The increasing use of the Internet in the collection of data and management of trials Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines Development of Standard Operating Procedures for the conduct of clinical trials Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels.

The Design and Analysis of Sequential Clinical Trials

John Whitehead
The Design and Analysis of Sequential Clinical Trials Book PDF

Author : John Whitehead
Publisher : Horwood Publishing Limited
Page : 280 pages
File Size : 41,8 Mb
Release : 1983
Category : Health & Fitness
ISBN : UOM:39015015600102

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The Design and Analysis of Sequential Clinical Trials by John Whitehead Pdf

This book details all aspects of sequential clinical trials from preliminary planning, through the monitoring of the trial, to the final analysis of the results.

Phase I Oncology Drug Development

Timothy A. Yap,Jordi Rodon,David S. Hong
Phase I Oncology Drug Development Book PDF

Author : Timothy A. Yap,Jordi Rodon,David S. Hong
Publisher : Springer Nature
Page : 352 pages
File Size : 47,7 Mb
Release : 2020-09-16
Category : Medical
ISBN : 9783030476823

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Phase I Oncology Drug Development by Timothy A. Yap,Jordi Rodon,David S. Hong Pdf

This book provides a detailed review of how oncology drug development has changed over the past decade, and serves as a comprehensive guide for the practicalities in setting up phase I trials. The book covers strategies to accelerate the development of novel antitumor compounds from the laboratory to clinical trials and beyond through the use of innovative mechanism-of-action pharmacodynamic biomarkers and pharmacokinetic studies. The reader will learn about all aspects of modern phase I trial designs, including the incorporation of precision medicine strategies, and approaches for rational patient allocation to novel anticancer therapies. Circulating biomarkers to assess mechanisms of response and resistance are changing the way we are assessing patient selection and are also covered in this book. The development of the different classes of antitumor agents are discussed, including chemotherapy, molecularly targeted agents, immunotherapies and also radiotherapy. The authors also discuss the lessons that the oncology field has learnt from the development of hematology-oncology drugs and how such strategies can be carried over into therapies for solid tumors. There is a dedicated chapter that covers the specialized statistical approaches necessary for phase I trial designs, including novel Bayesian strategies for dose escalation. This volume is designed to help clinicians better understand phase I clinical trials, but would also be of use to translational researchers (MDs and PhDs), and drug developers from academia and industry interested in cancer drug development. It could also be of use to phase I trial study coordinators, oncology nurses and advanced practice providers. Other health professionals interested in the treatment of cancer will also find this book of great value.