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Re Engineering Clinical Trials

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Re Engineering Clinical Trials

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Author : Peter Schueler
language : en
Publisher: Academic Press
Release Date : 2014-12-16

Re Engineering Clinical Trials written by Peter Schueler and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-12-16 with Medical categories.

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

Innovation In Clinical Trial Methodologies

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Author : Peter Schueler
language : en
Publisher: Academic Press
Release Date : 2020-11-01

Innovation In Clinical Trial Methodologies written by Peter Schueler and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-11-01 with Medical categories.

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

Nih

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Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
language : en
Publisher:
Release Date : 2004

Nih written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with Political Science categories.

Clinical Data Management

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Author : Richard K. Rondel
language : en
Publisher: John Wiley & Sons
Release Date : 2000-02-03

Clinical Data Management written by Richard K. Rondel and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000-02-03 with Medical categories.

Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature. The volume: * is written by well-known and experienced authors in this area * provides new approaches to major topics in clinical data management * contains new chapters on systems software validation, database design and performance measures. It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research.

Virtual Clinical Trials

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Author : Engineering National Academies of Sciences (and Medicine)
language : en
Publisher:
Release Date : 2019

Virtual Clinical Trials written by Engineering National Academies of Sciences (and Medicine) and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019 with Drugs categories.

Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.--Publishers website.

Departments Of Labor Health And Human Services Education And Related Agencies Appropriations For 2006

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Author : United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies
language : en
Publisher:
Release Date : 2005

Departments Of Labor Health And Human Services Education And Related Agencies Appropriations For 2006 written by United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005 with United States categories.

Clinical Trials

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Author : Tom Brody
language : en
Publisher: Academic Press
Release Date : 2016-02-19

Clinical Trials written by Tom Brody and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-02-19 with Medical categories.

Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers

Departments Of Labor Health And Human Services Education And Related Agencies Appropriations For 2005

Departments Of Labor Health And Human Services Education And Related Agencies Appropriations For 2005 written by United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with United States categories.

Departments Of Labor Health And Human Services Education And Related Agencies Appropriations For 2004

Departments Of Labor Health And Human Services Education And Related Agencies Appropriations For 2004 written by United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003 with United States categories.

108 1 Hearings Departments Of Labor Health And Human Services Education And Related Agencies Appropriations For 2004 Part 4a April 2 2003

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Author :
language : en
Publisher:
Release Date : 2003

108 1 Hearings Departments Of Labor Health And Human Services Education And Related Agencies Appropriations For 2004 Part 4a April 2 2003 written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003 with categories.

Re Engineering Clinical Trials

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