Innovation in Clinical Trial Methodologies Book

Innovation in Clinical Trial Methodologies


  • Author : Peter Schueler
  • Publisher : Academic Press
  • Release Date : 2020-11-01
  • Genre: Medical
  • Pages : 202
  • ISBN 10 : 9780323860062

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Innovation in Clinical Trial Methodologies Excerpt :

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

Innovative Strategies  Statistical Solutions and Simulations for Modern Clinical Trials Book

Innovative Strategies Statistical Solutions and Simulations for Modern Clinical Trials


  • Author : Mark Chang
  • Publisher : CRC Press
  • Release Date : 2019-03-20
  • Genre: Mathematics
  • Pages : 218
  • ISBN 10 : 9781351214520

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Innovative Strategies Statistical Solutions and Simulations for Modern Clinical Trials Excerpt :

"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 know

Re Engineering Clinical Trials Book

Re Engineering Clinical Trials


  • Author : Peter Schueler
  • Publisher : Academic Press
  • Release Date : 2014-12-16
  • Genre: Medical
  • Pages : 360
  • ISBN 10 : 9780128007907

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Re Engineering Clinical Trials Excerpt :

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

Report of the technical consultation on innovative clinical trial designs for development of new TB treatments Book

Report of the technical consultation on innovative clinical trial designs for development of new TB treatments


  • Author : Anonim
  • Publisher : World Health Organization
  • Release Date : 2021-07-28
  • Genre: Medical
  • Pages : null
  • ISBN 10 : 9789240030862

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Report of the technical consultation on innovative clinical trial designs for development of new TB treatments Excerpt :

The Global Tuberculosis Programme of the World Health Organization (WHO) convened a virtual technical consultation on “Innovative Clinical Trial Designs for Development of New TB Treatments” on 5 days between 20 August and 13 October 2021. The main objective of the meeting was to establish evidence-based approaches to trial designs and use of data to inform policy guidance of new regimens for the treatment of TB with the view to accelerate future regimen development. The consultation brought together researchers, academics, technical partners, TB drugs and regimens developers including pharmaceutical industry, trialists, regulators, guideline developers, programme managers, nongovernmental organizations and civil society.

Technological Innovation Book

Technological Innovation


  • Author : Annetine C. Gelijns
  • Publisher : National Academies
  • Release Date : 1989
  • Genre: Clinical medicine
  • Pages : 64
  • ISBN 10 : NAP:13516

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Technological Innovation Excerpt :

Drugs on Trial Book
Score: 2
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Drugs on Trial


  • Author : Andreas-Holger Maehle
  • Publisher : Rodopi
  • Release Date : 1999
  • Genre: History
  • Pages : 388
  • ISBN 10 : 9042007834

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Drugs on Trial Excerpt :

Experimental pharmacology is often portrayed as a creation of the nineteenth century, the age of the sciences in medicine. This book demonstrates that the basic methodology of the field, including chemical analysis,in vitro testing, animal experimentation and human research, was already developed in the course of the seventeenth and eighteenth centuries. Putting remedies on trial was stimulated by the challenge to Galenism through new chemical, mechanical and vitalist concepts of disease, by the import of exotic drugs and the flourishing trade with secret medicines. The book describes the main issues of eighteenth-century pharmacology and therapeutics and provides detailed case studies of three key areas: lithontriptics (remedies against urinary stones), opium, and Peruvian bark (quinine). It shows how pharmacological knowledge and therapeutic change were promoted in medical centres of the time, such as Edinburgh, London, Paris, Halle and Göttingen. Yet it also reveals how by publication of medical case histories many otherwise little-known practitioners contributed to this scientific enterprise as well.

Research Anthology on Innovative Research Methodologies and Utilization Across Multiple Disciplines Book

Research Anthology on Innovative Research Methodologies and Utilization Across Multiple Disciplines


  • Author : Management Association, Information Resources
  • Publisher : IGI Global
  • Release Date : 2021-12-30
  • Genre: Science
  • Pages : 663
  • ISBN 10 : 9781668438824

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Research Anthology on Innovative Research Methodologies and Utilization Across Multiple Disciplines Excerpt :

Research methodology is as old as academia itself. Research methodology shifts in strategy as it crosses different disciplines and theories. This, too, is true with the shifting landscape of research opportunities and technologies available to global researchers. To achieve the most accurate and substantial research, it is important to be knowledgeable of emerging research methodologies. The Research Anthology on Innovative Research Methodologies and Utilization Across Multiple Disciplines discusses the most recent global research innovations made across multiple fields. This anthology further discusses how these research methodologies can be applied to a variety of specific fields. Covering topics such as creative thinking, qualitative research, and the research method landscape, this book is essential for students and faculty of higher education, scientists, researchers, sociologists, computer scientists, and academicians.

Clinical Technologies  Concepts  Methodologies  Tools and Applications Book

Clinical Technologies Concepts Methodologies Tools and Applications


  • Author : Management Association, Information Resources
  • Publisher : IGI Global
  • Release Date : 2011-05-31
  • Genre: Medical
  • Pages : 2366
  • ISBN 10 : 9781609605629

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Clinical Technologies Concepts Methodologies Tools and Applications Excerpt :

"This multi-volume book delves into the many applications of information technology ranging from digitizing patient records to high-performance computing, to medical imaging and diagnostic technologies, and much more"--

Adaptive Design Methods in Clinical Trials Book

Adaptive Design Methods in Clinical Trials


  • Author : Shein-Chung Chow
  • Publisher : CRC Press
  • Release Date : 2006-11-16
  • Genre: Mathematics
  • Pages : 296
  • ISBN 10 : 9781584887775

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Adaptive Design Methods in Clinical Trials Excerpt :

Although adaptive design methods are flexible and useful in clinical research, little or no regulatory guidelines are available. One of the first books on the topic, Adaptive Design Methods in Clinical Trials presents the principles and methodologies in adaptive design and analysis that pertain to adaptations made to trial or statistical procedures

Modern Approaches to Clinical Trials Using SAS Book

Modern Approaches to Clinical Trials Using SAS


  • Author : Sandeep Menon
  • Publisher : Unknown
  • Release Date : 2015-12-09
  • Genre: Computers
  • Pages : 364
  • ISBN 10 : 1629593850

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Modern Approaches to Clinical Trials Using SAS Excerpt :

Get the tools you need to use SAS(r) 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.

Issues and Innovations in Prison Health Research Book

Issues and Innovations in Prison Health Research


  • Author : Matthew Maycock
  • Publisher : Springer Nature
  • Release Date : 2020-09-30
  • Genre: Social Science
  • Pages : 336
  • ISBN 10 : 9783030464011

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Issues and Innovations in Prison Health Research Excerpt :

This book constitutes the first publication to utilise a range of social science methodologies to illuminate diverse and new aspects of health research in prison settings. Prison contexts often have profound implications for the health of the people who live and work within them. Despite these settings often housing people from extremely disadvantaged and deprived communities, many with multiple and complex health needs, health research is generally neglected within both criminology and medical sociology. Through the fourteen chapters of this book, a range of issues emerge that the authors of each contribution reflect upon. The ethical concerns that emerge as a consequence of undertaking prison health research are not ignored, indeed these lie at the heart of this book and resonate across all the chapters. Foregrounding these issues necessarily forms a significant focus of this introductory chapter. Alongside explicitly considering emerging ethical issues, our contributing authors also have considered diverse aspects of innovation in research methodologies within the context of prison health research. Many of the chapters are innovative through the methodologies that were used, often adapting and utilising research methods rarely used within prison settings. The book brings together chapters from students, scholars, practitioners and service users from a range of disciplines (including medical sociology, medical anthropology, criminology, psychology and public health).

Transforming Clinical Research in the United States Book

Transforming Clinical Research in the United States


  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release Date : 2010-10-22
  • Genre: Medical
  • Pages : 150
  • ISBN 10 : 0309163358

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Transforming Clinical Research in the United States Excerpt :

An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effecti

Position statement on innovative clinical trial design for development of new TB treatments Book

Position statement on innovative clinical trial design for development of new TB treatments


  • Author : Anonim
  • Publisher : World Health Organization
  • Release Date : 2021-07-14
  • Genre: Medical
  • Pages : null
  • ISBN 10 : 9789240030800

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Position statement on innovative clinical trial design for development of new TB treatments Excerpt :

This position statement aims to support TB regimen development by highlighting key clinical trial characteristics to help advance novel therapies. It summarises key innovations in TB clinical trial designs, ranging from pharmacokinetic-pharmacodynamic (PK-PD) modelling and new advances in biomarker development to the value of novel clinical trial design methodologies and post-licensure observational studies. For various stages along the development pathway, outstanding challenges are described alongside possible solutions to help overcome these issues. Beyond a welcome expansion of the TB drug pipeline, innovations in TB drug development and clinical trial design are anticipated to accelerate the development and evaluation as well as facilitate approval of novel regimens to treat all forms of TB.

Software Innovations in Clinical Drug Development and Safety Book

Software Innovations in Clinical Drug Development and Safety


  • Author : Chakraborty, Partha
  • Publisher : IGI Global
  • Release Date : 2015-10-02
  • Genre: Medical
  • Pages : 303
  • ISBN 10 : 9781466687271

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Software Innovations in Clinical Drug Development and Safety Excerpt :

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.