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Innovation In Clinical Trial Methodologies

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Innovation in Clinical Trial Methodologies

Innovation in Clinical Trial Methodologies Book
Author : Peter Schueler
Publisher : Academic Press
Release : 2020-11-01
ISBN : 0323860060
Language : En, Es, Fr & De

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Book Description :

Innovation in Clinical Trial Methodologies: Lessons Learned during the Corona Pandemic presents a selection of updated chapters from Re-Engineering Clinical Trials that feature innovative options and methods in clinical trials. The Coronavirus pandemic is an accelerator for digitalization in many industries, including clinical trials. This book considers best practices, alternative study concepts requiring fewer patients, studies with less patient interaction, the design of "virtualized" protocols, and moving from data to decisions. This book will be helpful to pharmacologists, physicians and clinical researchers involved in the process of clinical development and clinical trial design. Considers multiple digital and virtual strategies Explores best practices, including the use of reduced patient involvement Brings together expert, trusted information to increase the efficiency and effectiveness of clinical trials

Departments of Labor Health and Human Services Education and Related Agencies Appropriations for 2001

Departments of Labor  Health and Human Services  Education  and Related Agencies Appropriations for 2001 Book
Author : United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies
Publisher : Unknown
Release : 2000
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Departments of Labor Health and Human Services Education and Related Agencies Appropriations for 2001 book written by United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Innovative Methods for Rare Disease Drug Development

Innovative Methods for Rare Disease Drug Development Book
Author : Shein-Chung Chow
Publisher : CRC Press
Release : 2020-11-11
ISBN : 1000208338
Language : En, Es, Fr & De

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Book Description :

In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition that affects fewer than 200,000 persons. For the approval of "orphan" drug products for rare diseases, the traditional approach of power analysis for sample size calculation is not feasible because there are only limited number of subjects available for clinical trials. In this case, innovative approaches are needed for providing substantial evidence meeting the same standards for statistical assurance as drugs used to treat common conditions. Innovative Methods for Rare Disease Drug Development focuses on biostatistical applications in terms of design and analysis in pharmaceutical research and development from both regulatory and scientific (statistical) perspectives. Key Features: Reviews critical issues (e.g., endpoint/margin selection, sample size requirements, and complex innovative design). Provides better understanding of statistical concepts and methods which may be used in regulatory review and approval. Clarifies controversial statistical issues in regulatory review and approval accurately and reliably. Makes recommendations to evaluate rare diseases regulatory submissions. Proposes innovative study designs and statistical methods for rare diseases drug development, including n-of-1 trial design, adaptive trial design, and master protocols like platform trials. Provides insight regarding current regulatory guidance on rare diseases drug development like gene therapy.

Modern Approaches to Clinical Trials Using SAS

Modern Approaches to Clinical Trials Using SAS Book
Author : Sandeep Menon,Richard C. Zink
Publisher : SAS Institute
Release : 2015-12-09
ISBN : 1629600822
Language : En, Es, Fr & De

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Book Description :

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.

Software Innovations in Clinical Drug Development and Safety

Software Innovations in Clinical Drug Development and Safety Book
Author : Chakraborty, Partha
Publisher : IGI Global
Release : 2015-10-02
ISBN : 1466687274
Language : En, Es, Fr & De

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Book Description :

In light of the rising cost of healthcare and the overall challenges associated with delivering quality care to patients across regions, scientists and pharmacists are exploring new initiatives in drug discovery and design. One such initiative is the adoption of information technology and software applications to improve healthcare and pharmaceutical processes. Software Innovations in Clinical Drug Development and Safety is a comprehensive resource analyzing the integration of software engineering for the purpose of drug discovery, clinical trials, genomics, and drug safety testing. Taking a multi-faceted approach to the application of computational methods to pharmaceutical science, this publication is ideal for healthcare professionals, pharmacists, computer scientists, researchers, and students seeking the latest information on the architecture and design of software in clinical settings, the impact of clinical technologies on business models, and the safety and privacy of patients and patient data. This timely resource features a well-rounded discussion on topics pertaining to the integration of computational methods in pharmaceutical science and practice including, the impact of software integration on business models, patient safety concerns, software architecture and design, and data security.

Wiley Encyclopedia of Clinical Trials

Wiley Encyclopedia of Clinical Trials Book
Author : Lisa Marie Sullivan,Joseph Massaro
Publisher : Wiley-Interscience
Release : 2008
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Here you'll find more than 500 entries from the world's leading experts in the field on the basic concepts, methodologies, and applications in clinical trials. The range of topics includes: basic statistical concepts, design and analysis of clinical trials, ethics, regulatory issues, and methodologies for clinical data management and analysis

Issues in Surgical Research Techniques and Innovation 2011 Edition

Issues in Surgical Research  Techniques  and Innovation  2011 Edition Book
Author : Anonim
Publisher : ScholarlyEditions
Release : 2012-01-09
ISBN : 1464963932
Language : En, Es, Fr & De

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Book Description :

Issues in Surgical Research, Techniques, and Innovation: 2011 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Surgical Research, Techniques, and Innovation. The editors have built Issues in Surgical Research, Techniques, and Innovation: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Surgical Research, Techniques, and Innovation in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Surgical Research, Techniques, and Innovation: 2011 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.

Innovative Strategies Statistical Solutions and Simulations for Modern Clinical Trials

Innovative Strategies  Statistical Solutions and Simulations for Modern Clinical Trials Book
Author : Mark Chang,John Balser,Jim Roach,Robin Bliss
Publisher : CRC Press
Release : 2019-03-29
ISBN : 1351214527
Language : En, Es, Fr & De

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Book Description :

"This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.

Innovative Treatment Methods in Psychopathology

Innovative Treatment Methods in Psychopathology Book
Author : Henry E. Adams
Publisher : Wiley-Interscience
Release : 1974
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Innovative Treatment Methods in Psychopathology book written by Henry E. Adams, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

New Drug Development

New Drug Development Book
Author : J. Rick Turner
Publisher : Springer Science & Business Media
Release : 2010-07-16
ISBN : 9781441964182
Language : En, Es, Fr & De

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Book Description :

New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected—numerical representations of biological information—are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials.

The Economics of Drug Innovation

The Economics of Drug Innovation Book
Author : American University, Washington, D.C. Center for the Study of Private Enterprise
Publisher : Washington : American University, Center for the Study of Private Enterprise, School of Business Administration
Release : 1970
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download The Economics of Drug Innovation book written by American University, Washington, D.C. Center for the Study of Private Enterprise, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Guide to Paediatric Clinical Research

Guide to Paediatric Clinical Research Book
Author : Klaus Rose,John N. Van den Anker
Publisher : Karger Medical and Scientific Publishers
Release : 2007
ISBN : 3805582013
Language : En, Es, Fr & De

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Book Description :

As off-label use of medicines in children is no longer acceptable today, paediatric drug development is currently in transition from an almost exclusive academic specialty towards an integrated part of the global process that drives the development of new pharmaceuticals. US and EU governments have made it mandatory for the pharmaceutical industry to investigate medicines in children, thus exposing a multitude of different institutions to paediatric research. Written by exponents of the academia as well as the pharmaceutical industry, regulators and patient advocacy groups, this book explains the background of the US and EU paediatric legislations, gives an analysis of their probable short-, mid- and long-term impact, addresses key operational challenges in paediatric research, and develops a tentative vision where paediatric drug development needs to go. Helping to understand the role of the different stakeholders, the spectrum of readers to profit from this book ranges from paediatricians, general medical personnel and pharmacologists to those involved in regulatory affairs and clinical trials, pharmaceutical company management, patient advocacy groups, ethical committees, politicians and interested lay persons.

The Effectiveness of Innovative Approaches in the Treatment of Drug Abuse

The Effectiveness of Innovative Approaches in the Treatment of Drug Abuse Book
Author : Frank M. Tims,James A. Inciardi,Bennett W. Fletcher,Arthur MacNeill Horton, Jr.
Publisher : Praeger
Release : 1997
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

A continuation of the study researched in their previous volumes, this new book looks at the effectiveness of various treatment approaches. These essays represent an effort to systematically integrate science and practice in order to improve drug abuse treatment.

Re Engineering Clinical Trials

Re Engineering Clinical Trials Book
Author : Peter Schueler,Brendan Buckley
Publisher : Academic Press
Release : 2014-12-16
ISBN : 0128007907
Language : En, Es, Fr & De

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Book Description :

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

Using Research to Improve Nursing Practice a Guide

Using Research to Improve Nursing Practice  a Guide Book
Author : Jo Anne Horsley
Publisher : Saunders
Release : 1983
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Using Research to Improve Nursing Practice a Guide book written by Jo Anne Horsley, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Analysis of Drug Innovation

Analysis of Drug Innovation Book
Author : J. F. Miquel,J. R. Prous
Publisher : Unknown
Release : 1981
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Analysis of Drug Innovation book written by J. F. Miquel,J. R. Prous, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Statistical Approaches in Oncology Clinical Development

Statistical Approaches in Oncology Clinical Development Book
Author : Satrajit Roychoudhury,Soumi Lahiri
Publisher : CRC Press
Release : 2018-03
ISBN : 9781498772693
Language : En, Es, Fr & De

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Book Description :

Statistical Challenges in Oncology Clinical Development presents an overview of statistical considerations in oncology clinical trials, including both early and late phase of development. It illustrates how the novel statistical methods can enrich the design and analysis of modern oncology trials. The book covers wide spectrum of statistical methodology with real life examples. The book covers all aspects of cancer clinical trial starting from early phase development. The early part of the book covers novel phase I dose escalation design, exposure response analysis and innovative phase II design. This includes early development strategy for cancer immunotherapy trials. The authors also emphasized the role of biomarker and modern era of precision medicine. The second part focuses on the late stage development. This includes the application of adaptive design, safety analysis and quality of life data analysis. The final part discusses current regulatory perspective and challenges. Statisticians, key opinion leaders and strategy makers involved in oncology trials will find this book useful. This book provides researchers a solid overview of available methodologies. Along with describing the necessary statistical theory, the authors illustrate the practical application of the techniques. The authors include many relevant real life examples from pharmaceutical industry and academia based on their first-hand experience. Along with relevant references, the book highlights current regulatory views. Features: It covers a wide spectrum of topics related to real life statistical challenges in oncology clinical trials. This provides a comprehensive overview of novel statistical methods to improve trial design and statistical analysis. Detailed case studies illustrate the real-life applications. Authors are eminent members from pharmaceutical industry, FDA and academia who have several years of hands in experience in clinical trial.

Innovative Statistics in Regulatory Science

Innovative Statistics in Regulatory Science Book
Author : Shein-Chung Chow
Publisher : CRC Press
Release : 2019-11-18
ISBN : 1000710033
Language : En, Es, Fr & De

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Book Description :

Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in the review and approval process of regulatory submissions of pharmaceutical products. In addition, statistics in regulatory science are involved with the development of regulatory policy, guidance, and regulatory critical clinical initiatives related research. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are commonly encountered in regulatory science of pharmaceutical research and development including topics related to research activities, review of regulatory submissions, recent critical clinical initiatives, and policy/guidance development in regulatory science. Devoted entirely to discussing statistics in regulatory science for pharmaceutical development. Reviews critical issues (e.g., endpoint/margin selection and complex innovative design such as adaptive trial design) in the pharmaceutical development and regulatory approval process. Clarifies controversial statistical issues (e.g., hypothesis testing versus confidence interval approach, missing data/estimands, multiplicity, and Bayesian design and approach) in review/approval of regulatory submissions. Proposes innovative thinking regarding study designs and statistical methods (e.g., n-of-1 trial design, adaptive trial design, and probability monitoring procedure for sample size) for rare disease drug development. Provides insight regarding current regulatory clinical initiatives (e.g., precision/personalized medicine, biomarker-driven target clinical trials, model informed drug development, big data analytics, and real world data/evidence). This book provides key statistical concepts, innovative designs, and analysis methods that are useful in regulatory science. Also included are some practical, challenging, and controversial issues that are commonly seen in the review and approval process of regulatory submissions. About the author Shein-Chung Chow, Ph.D. is currently a Professor at Duke University School of Medicine, Durham, NC. He was previously the Associate Director at the Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA). Dr. Chow has also held various positions in the pharmaceutical industry such as Vice President at Millennium, Cambridge, MA, Executive Director at Covance, Princeton, NJ, and Director and Department Head at Bristol-Myers Squibb, Plainsboro, NJ. He was elected Fellow of the American Statistical Association and an elected member of the ISI (International Statistical Institute). Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Biostatistics Book Series, Chapman and Hall/CRC Press, Taylor & Francis, New York. Dr. Chow is the author or co-author of over 300 methodology papers and 30 books.

Analysis of Clinical Trials Using SAS

Analysis of Clinical Trials Using SAS Book
Author : Alex Dmitrienko,Gary G. Koch
Publisher : SAS Institute
Release : 2017-07-17
ISBN : 1635261449
Language : En, Es, Fr & De

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Book Description :

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.