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Author : Shiva Ravindra
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.8/5 (944 download)
Download or read book Efficacy & Oncology SAS written by Shiva Ravindra and published by . This book was released on 2024-05-29 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Sandeep Menon
Publisher : SAS Institute
ISBN 13 : 1629600822
Total Pages : 482 pages
Book Rating : 4.6/5 (296 download)
Download or read book Modern Approaches to Clinical Trials Using SAS written by Sandeep Menon and published by SAS Institute. This book was released on 2015-12-09 with total page 482 pages. Available in PDF, EPUB and Kindle. Book excerpt: Get the tools you need to use SAS® in clinical trial design! Unique and multifaceted, Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods, edited by Sandeep M. Menon and Richard C. Zink, thoroughly covers several domains of modern clinical trial design: classical, group sequential, adaptive, and Bayesian methods that are applicable to and widely used in various phases of pharmaceutical development. Written for biostatisticians, pharmacometricians, clinical developers, and statistical programmers involved in the design, analysis, and interpretation of clinical trials, as well as students in graduate and postgraduate programs in statistics or biostatistics, the book touches on a wide variety of topics, including dose-response and dose-escalation designs; sequential methods to stop trials early for overwhelming efficacy, safety, or futility; Bayesian designs that incorporate historical data; adaptive sample size re-estimation; adaptive randomization to allocate subjects to more effective treatments; and population enrichment designs. Methods are illustrated using clinical trials from diverse therapeutic areas, including dermatology, endocrinology, infectious disease, neurology, oncology, and rheumatology. Individual chapters are authored by renowned contributors, experts, and key opinion leaders from the pharmaceutical/medical device industry or academia. Numerous real-world examples and sample SAS code enable users to readily apply novel clinical trial design and analysis methodologies in practice.
Author : Alex Dmitrienko
Publisher : SAS Institute
ISBN 13 : 1635261449
Total Pages : 455 pages
Book Rating : 4.6/5 (352 download)
Download or read book Analysis of Clinical Trials Using SAS written by Alex Dmitrienko and published by SAS Institute. This book was released on 2017-07-17 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: Analysis of Clinical Trials Using SAS®: A Practical Guide, Second Edition bridges the gap between modern statistical methodology and real-world clinical trial applications. Tutorial material and step-by-step instructions illustrated with examples from actual trials serve to define relevant statistical approaches, describe their clinical trial applications, and implement the approaches rapidly and efficiently using the power of SAS. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials. Commonly used methods are covered, including dose-escalation and dose-finding methods that are applied in Phase I and Phase II clinical trials, as well as important trial designs and analysis strategies that are employed in Phase II and Phase III clinical trials, such as multiplicity adjustment, data monitoring, and methods for handling incomplete data. This book also features recommendations from clinical trial experts and a discussion of relevant regulatory guidelines. This new edition includes more examples and case studies, new approaches for addressing statistical problems, and the following new technological updates: SAS procedures used in group sequential trials (PROC SEQDESIGN and PROC SEQTEST) SAS procedures used in repeated measures analysis (PROC GLIMMIX and PROC GEE) macros for implementing a broad range of randomization-based methods in clinical trials, performing complex multiplicity adjustments, and investigating the design and analysis of early phase trials (Phase I dose-escalation trials and Phase II dose-finding trials) Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience and the ready-to-use SAS macros compiled in this book.
Author : Ding-Geng (Din) Chen
Publisher : CRC Press
ISBN 13 : 1351651145
Total Pages : 385 pages
Book Rating : 4.3/5 (516 download)
Download or read book Clinical Trial Data Analysis Using R and SAS written by Ding-Geng (Din) Chen and published by CRC Press. This book was released on 2017-06-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Sanjay Matange
Publisher : SAS Institute
ISBN 13 : 1629602078
Total Pages : 270 pages
Book Rating : 4.6/5 (296 download)
Download or read book Clinical Graphs Using SAS written by Sanjay Matange and published by SAS Institute. This book was released on 2016-03-21 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: SAS users in the Health and Life Sciences industry need to create complex graphs to analyze biostatistics data and clinical data, and they need to submit drugs for approval to the FDA. Graphs used in the HLS industry are complex in nature and require innovative usage of the graphics features. Clinical Graphs Using SAS® provides the knowledge, the code, and real-world examples that enable you to create common clinical graphs using SAS graphics tools, such as the Statistical Graphics procedures and the Graph Template Language. This book describes detailed processes to create many commonly used graphs in the Health and Life Sciences industry. For SAS® 9.3 and SAS® 9.4 it covers many improvements in the graphics features that are supported by the Statistical Graphics procedures and the Graph Template Language, many of which are a direct result of the needs of the Health and Life Sciences community. With the addition of new features in SAS® 9.4, these graphs become positively easy to create. Topics covered include the usage of SGPLOT procedure, the SGPANEL procedure and the Graph Template Language for the creation of graphs like forest plots, swimmer plots, and survival plots.
Author : Jack Shostak
Publisher :
ISBN 13 : 9781590477939
Total Pages : 0 pages
Book Rating : 4.4/5 (779 download)
Download or read book SAS Programming in the Pharmaceutical Industry written by Jack Shostak and published by . This book was released on 2005 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This real-world reference for clinical trial SAS programming is packed with solutions that can be applied day-to-day problems. Organized to reflect the statistical programmers workflow, this user-friendly text begins with an introduction to the working environment, then presents chapters on importing and massaging data into analysis data sets, producing clinical trial output, and exporting data.
Author : Y. LAKSHMI PRASAD
Publisher : Notion Press
ISBN 13 : 9384381896
Total Pages : 444 pages
Book Rating : 4.3/5 (843 download)
Download or read book SAS Clinical Programming written by Y. LAKSHMI PRASAD and published by Notion Press. This book was released on 2014-09-12 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: An indispensable guide to SAS Clinical Programming, this book is the first guide on this topic, to be written by an Indian author. Written in an instructive and conversational tone for people who want to make their career in SAS Clinical Programming and entry level programmers for their day-to-day tasks. It is equipped with practical, real world examples, detailed description of programs, work flows, issues, resolutions and key techniques. This book is a personal SAS Clinical trainer. It explains the art of SAS Clinical Programming in eighteen easy steps, covering everything from basics to ADS, TLF Creation, as well as CDISC SDTM and ADaM specifications. Many statistical concepts are explained in an easy way so that you feel confident while using Statistical Procedures. If you are already working as a SAS Clinical Programmer, this book will aid you with sharpening your skills.
Author : Iftekhar Khan
Publisher : CRC Press
ISBN 13 : 1466505486
Total Pages : 332 pages
Book Rating : 4.4/5 (665 download)
Download or read book Design & Analysis of Clinical Trials for Economic Evaluation & Reimbursement written by Iftekhar Khan and published by CRC Press. This book was released on 2015-11-11 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Economic evaluation has become an essential component of clinical trial design to show that new treatments and technologies offer value to payers in various healthcare systems. Although many books exist that address the theoretical or practical aspects of cost-effectiveness analysis, this book differentiates itself from the competition by detailing
Author : Alexander Drilon
Publisher : Lippincott Williams & Wilkins
ISBN 13 : 1451187629
Total Pages : 352 pages
Book Rating : 4.4/5 (511 download)
Download or read book Pocket Oncology written by Alexander Drilon and published by Lippincott Williams & Wilkins. This book was released on 2014 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pocket Oncology, developed and edited by oncologists at Memorial Sloan-Kettering Cancer Center, is a simple, yet comprehensive, review of basic principles of cancer management. Prepared in the style and format of books in the popular Pocket Notebook series, Pocket Oncology is intended as a quick reference presented in easy to read bulleted text, and using diagrams and charts where appropriate. Each oncologic disease is presented on two facing pages that review initial clinical presentation, pathophysiology, staging, current standard of care treatments, and active areas of current research. Edited by Alexander Drilon and Michael Postow, the content of the book has been written by medical oncology fellows and each disease entity has been authoritatively reviewed by an oncologist with specific expertise in each subspecialty of oncology. Features: -simple, comprehensive, review of basic principles of oncology in easy to read bulleted text, using diagrams and charts where appropriate. -its small size makes it easy to carry the pocket of a lab coat for quick reference to information while in the hospital or oncology clinic. -perfect for medical students, residents, fellows, physician assistants, and nurses who perform daily oncologic care.
Author : Ron Cody
Publisher : SAS Institute
ISBN 13 : 1635260698
Total Pages : 234 pages
Book Rating : 4.6/5 (352 download)
Download or read book Cody's Data Cleaning Techniques Using SAS, Third Edition written by Ron Cody and published by SAS Institute. This book was released on 2017-03-15 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written in Ron Cody's signature informal, tutorial style, this book develops and demonstrates data cleaning programs and macros that you can use as written or modify which will make your job of data cleaning easier, faster, and more efficient. --
Author : John P. Klein
Publisher : Springer Science & Business Media
ISBN 13 : 1475727283
Total Pages : 508 pages
Book Rating : 4.4/5 (757 download)
Download or read book Survival Analysis written by John P. Klein and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 508 pages. Available in PDF, EPUB and Kindle. Book excerpt: Making complex methods more accessible to applied researchers without an advanced mathematical background, the authors present the essence of new techniques available, as well as classical techniques, and apply them to data. Practical suggestions for implementing the various methods are set off in a series of practical notes at the end of each section, while technical details of the derivation of the techniques are sketched in the technical notes. This book will thus be useful for investigators who need to analyse censored or truncated life time data, and as a textbook for a graduate course in survival analysis, the only prerequisite being a standard course in statistical methodology.
Author : Chris Holland
Publisher : SAS Institute
ISBN 13 : 1642952419
Total Pages : 294 pages
Book Rating : 4.6/5 (429 download)
Download or read book Implementing CDISC Using SAS written by Chris Holland and published by SAS Institute. This book was released on 2019-05-30 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: For decades researchers and programmers have used SAS to analyze, summarize, and report clinical trial data. Now Chris Holland and Jack Shostak have updated their popular Implementing CDISC Using SAS, the first comprehensive book on applying clinical research data and metadata to the Clinical Data Interchange Standards Consortium (CDISC) standards. Implementing CDISC Using SAS: An End-to-End Guide, Revised Second Edition, is an all-inclusive guide on how to implement and analyze the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM) data and prepare clinical trial data for regulatory submission. Updated to reflect the 2017 FDA mandate for adherence to CDISC standards, this new edition covers creating and using metadata, developing conversion specifications, implementing and validating SDTM and ADaM data, determining solutions for legacy data conversions, and preparing data for regulatory submission. The book covers products such as Base SAS, SAS Clinical Data Integration, and the SAS Clinical Standards Toolkit, as well as JMP Clinical. Topics included in this edition include an implementation of the Define-XML 2.0 standard, new SDTM domains, validation with Pinnacle 21 software, event narratives in JMP Clinical, STDM and ADAM metadata spreadsheets, and of course new versions of SAS and JMP software. The second edition was revised to add the latest C-Codes from the most recent release as well as update the make_define macro that accompanies this book in order to add the capability to handle C-Codes. The metadata spreadsheets were updated accordingly. Any manager or user of clinical trial data in this day and age is likely to benefit from knowing how to either put data into a CDISC standard or analyzing and finding data once it is in a CDISC format. If you are one such person--a data manager, clinical and/or statistical programmer, biostatistician, or even a clinician--then this book is for you.
Author : John D. Kalbfleisch
Publisher : John Wiley & Sons
ISBN 13 : 1118031237
Total Pages : 462 pages
Book Rating : 4.1/5 (18 download)
Download or read book The Statistical Analysis of Failure Time Data written by John D. Kalbfleisch and published by John Wiley & Sons. This book was released on 2011-01-25 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contains additional discussion and examples on left truncationas well as material on more general censoring and truncationpatterns. Introduces the martingale and counting process formulation swillbe in a new chapter. Develops multivariate failure time data in a separate chapterand extends the material on Markov and semi Markovformulations. Presents new examples and applications of data analysis.
Author : Agency for Health Care Research and Quality (U.S.)
Publisher : Government Printing Office
ISBN 13 : 1587634236
Total Pages : 236 pages
Book Rating : 4.5/5 (876 download)
Download or read book Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide written by Agency for Health Care Research and Quality (U.S.) and published by Government Printing Office. This book was released on 2013-02-21 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)
Author : Simon S. Lo
Publisher : Springer Science & Business Media
ISBN 13 : 364225604X
Total Pages : 433 pages
Book Rating : 4.6/5 (422 download)
Download or read book Stereotactic Body Radiation Therapy written by Simon S. Lo and published by Springer Science & Business Media. This book was released on 2012-08-28 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: Stereotactic body radiation therapy (SBRT) has emerged as an important innovative treatment for various primary and metastatic cancers. This book provides a comprehensive and up-to-date account of the physical/technological, biological, and clinical aspects of SBRT. It will serve as a detailed resource for this rapidly developing treatment modality. The organ sites covered include lung, liver, spine, pancreas, prostate, adrenal, head and neck, and female reproductive tract. Retrospective studies and prospective clinical trials on SBRT for various organ sites from around the world are examined, and toxicities and normal tissue constraints are discussed. This book features unique insights from world-renowned experts in SBRT from North America, Asia, and Europe. It will be necessary reading for radiation oncologists, radiation oncology residents and fellows, medical physicists, medical physics residents, medical oncologists, surgical oncologists, and cancer scientists.
Author : Akihiro Hirakawa
Publisher : Springer
ISBN 13 : 4431555730
Total Pages : 100 pages
Book Rating : 4.4/5 (315 download)
Download or read book Modern Dose-Finding Designs for Cancer Phase I Trials: Drug Combinations and Molecularly Targeted Agents written by Akihiro Hirakawa and published by Springer. This book was released on 2018-01-30 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book deals with advanced methods for adaptive phase I dose-finding clinical trials for combination of two agents and molecularly targeted agents (MTAs) in oncology. It provides not only methodological aspects of the dose-finding methods, but also software implementations and practical considerations in applying these complex methods to real cancer clinical trials. Thus, the book aims to furnish researchers in biostatistics and statistical science with a good summary of recent developments of adaptive dose-finding methods as well as providing practitioners in biostatistics and clinical investigators with advanced materials for designing, conducting, monitoring, and analyzing adaptive dose-finding trials. The topics in the book are mainly related to cancer clinical trials, but many of those topics are potentially applicable or can be extended to trials for other diseases. The focus is mainly on model-based dose-finding methods for two kinds of phase I trials. One is clinical trials with combinations of two agents. Development of dose-finding methods for two-agent combination trials requires reasonable models that can adequately capture joint toxicity probabilities for two agents, taking into consideration possible interactions of the two agents on toxicity probability such as synergistic or antagonistic effects. Another is clinical trials for evaluating both efficacy and toxicity outcomes in single- and two-agent combination trials. These methods are often applied to the phase I trials including MTAs because the toxicity and efficacy for a MTA does not monotonically increase with dose, but the efficacy often increases initially with the dose and then plateaus. Successful software implementations for several dose-finding methods are introduced in the book, and their operating characteristics in practice are discussed. Recent advance of the adaptive dose-finding methods in drug developments are also provided.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309457971
Total Pages : 145 pages
Book Rating : 4.3/5 (94 download)
Download or read book The Drug Development Paradigm in Oncology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-02-12 with total page 145 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.
