A Comprehensive And Practical Guide To Clinical Trials

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A Comprehensive And Practical Guide To Clinical Trials

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Author : Delva Shamley
language : en
Publisher: Academic Press
Release Date : 2017-06-07

A Comprehensive And Practical Guide To Clinical Trials written by Delva Shamley and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-06-07 with Medical categories.

A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end. - Describes the entire clinical trial management process from start to finish in a step-by-step guide - Provides best practice elements, including case studies, practical examples, activities, and checklists

A Practical Guide To Managing Clinical Trials

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Author : JoAnn Pfeiffer
language : en
Publisher: CRC Press
Release Date : 2017-05-18

A Practical Guide To Managing Clinical Trials written by JoAnn Pfeiffer and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-05-18 with Mathematics categories.

A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.

The Practical Guide To Clinical Research And Publication

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Author : Uzung Yoon
language : en
Publisher: Academic Press
Release Date : 2021-08-03

The Practical Guide To Clinical Research And Publication written by Uzung Yoon and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-08-03 with Medical categories.

The Practical Guide to Clinical Research and Publication provides a comprehensive overview of the key foundations of epidemiology, statistics and epidemiological studies. This book presents the most important terms and knowledge in the field from a medical point-of-view. Sections contain numerous, clinically-oriented examples and drawings to facilitate understanding and clarify the relation to clinic and practice. The book contains many graphics and key points for easier understanding and is written using bullet points for ease of use and comprehension. It is ideal for physicians and clinical researchers who want to use it as guidance for clinical research or teaching. - Contains numerous, clinically-oriented examples and drawings - Provides an explanation of epidemiology and statistics to aid understanding of clinical research - Written by a physician with extensive knowledge in research

Clinical Trials

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Author : Duolao Wang
language : en
Publisher: Remedica
Release Date : 2006

Clinical Trials written by Duolao Wang and has been published by Remedica this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006 with Medical categories.

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.

Practical Guide To Clinical Data Management Third Edition

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Author : Susanne Prokscha
language : en
Publisher: CRC Press
Release Date : 2011-10-26

Practical Guide To Clinical Data Management Third Edition written by Susanne Prokscha and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-10-26 with Computers categories.

The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then, the third edition of Practical Guide to Clinical Data Management includes important updates to all chapters to reflect the current industry approach to using electronic data capture (EDC) for most studies. See what’s new in the Third Edition: A chapter on the clinical trial process that explains the high level flow of a clinical trial from creation of the protocol through the study lock and provides the context for the clinical data management activities that follow Reorganized content reflects an industry trend that divides training and standard operating procedures for clinical data management into the categories of study startup, study conduct, and study closeout Coverage of current industry and Food and Drug Administration (FDA) approaches and concerns The book provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks. It also details the context of regulations that guide how those systems are used and how those regulations are applied to their installation and maintenance. Keeping the coverage practical rather than academic, the author hones in on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview or introduction for clinical data managers.

Principles And Practice Of Clinical Research

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Author : John I. Gallin
language : en
Publisher: Academic Press
Release Date : 2017-11-17

Principles And Practice Of Clinical Research written by John I. Gallin and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-11-17 with Science categories.

Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications. In addition to key topics such as bioethics, clinical outcome data, cultural diversity, protocol guidelines, and "omic platforms, this edition contains new chapters devoted to electronic health records and information resources for clinical researchers, as well as the many opportunities associated with big data. Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting research. - Features input from experts in the field dedicated to translating scientific research from bench to bedside and back - Provides expanded coverage of global clinical research - Contains hands-on, practical suggestions, illustrations, and examples throughout - Includes new chapters on the international regulation of drugs and biologics, the emergence of the important role of comparative effectiveness research and how to identify clinical risks and manage patient safety in a clinical research setting

The Sourcebook For Clinical Research

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Author : Natasha Martien
language : en
Publisher: Academic Press
Release Date : 2018-08-01

The Sourcebook For Clinical Research written by Natasha Martien and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-08-01 with Medical categories.

A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: https://www.elsevier.com/books-and-journals/book-companion/9780128162422/order-display-posters. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic. - Makes vital trial conduct information easy to understand and instructs on how to practically apply current Federal regulations and Good Clinical Practice (ICH GCP) - Offers extensive guidance that is crucial for guaranteeing compliance to clinical research regulations during each step of the clinical research process - Provides up-to-date and extensive coverage of beginning to advanced topics, and, step-by-step actions to take during exceptional circumstances, including compassionate use, emergency use, human subjects protections for vulnerable populations, and federal audits - Furnishes a detailed clinical research Glossary, and a comprehensive Appendix containing ready-to-use forms, templates, and checklists for clinical trial personnel to download and begin using immediately. - Written for the fast-paced clinic environment with action steps and forms in the book to respond to a research subject's needs urgently and compliantly

Mrna Therapeutics

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Author : Anya Hillery
language : en
Publisher: Elsevier
Release Date : 2024-09-09

Mrna Therapeutics written by Anya Hillery and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-09-09 with Medical categories.

mRNA Therapeutics: Foundations, Innovations and Clinical Applications aims to provide a comprehensive text that covers all aspects of mRNA therapeutics, from the foundational science that underpins this disruptive new drug class, through the scientific and technological breakthroughs crucial for therapeutic success, to the current clinical applications and the innovative advances driving future directions. The book begins with foundational knowledge covering mRNA biology, the immune system, and vaccines. The second section addresses the major challenges associated with mRNA as a therapeutic modality, and the molecular engineering innovations and delivery technologies that have allowed these hurdles to be largely overcome. The third section describes the current and future clinical applications of mRNA therapeutics that are transforming, or are poised to transform, medicine and health. This includes the use of mRNA vaccines for COVID-19 and other infectious diseases, as well as mRNA's role in revolutionizing cancer immunotherapy, covering immunostimulants, cancer vaccines including personalized neoantigen vaccines, and CAR T cell technologies. Additional chapters describe the use of mRNA therapeutics for protein replacement therapy and gene-editing, as well as newer mRNA constructs, including self-amplifying mRNA. The final section addresses the safety and regulatory considerations of mRNA therapeutics, along with broader cultural issues including vaccine hesitancy, global vaccine inequality, and pandemic preparedness. Currently, mRNA texts either provide personal accounts from key players involved in COVID-19 vaccine development, with limited scientific depth, or focus on highly specialized, more esoteric applications of mRNA in advanced molecular biology. This book aims to bridge this gap by providing a scientifically rigorous and wide-ranging exploration of mRNA's role in therapeutics. This pioneering textbook serves as a vital addition to the academic canon, providing an essential tool for the current and next generation of students, scientists, researchers and professionals in a wide variety of related disciplines including molecular biology, biomedical engineering, pharmaceutical science, oncology, and the health sciences. - Focuses on the science of mRNA, covering the development, modus operandi, platform manufacturing technology, safety, and efficacy of this treatment modality - Provides the mRNA technology fit with the wider context of vaccinology, virology, oncology, biotechnology, as well as manufacturing and regulatory science - Offers an understanding of the recent paradigm shift in the way we treat disease

Basics And Clinical Applications Of Drug Disposition In Special Populations

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Author : Seth Kwabena Amponsah
language : en
Publisher: John Wiley & Sons
Release Date : 2025-04-08

Basics And Clinical Applications Of Drug Disposition In Special Populations written by Seth Kwabena Amponsah 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 2025-04-08 with Medical categories.

An up-to-date exploration of techniques for effectively treating patients from special populations In Basics and Clinical Applications of Drug Disposition in Special Populations, a team of distinguished researchers delivers a timely and authoritative discussion of how to predict drug disposition in special populations, including people with obesity, pediatric patients, geriatric patients, and patients with renal and hepatic impairment. The authors use pharmacokinetic models to account for variabilities between populations and to better predict drug disposition. The book offers a collection of 15 chapters written by recognized experts in their respective fields. They cover topics ranging from the optimization of drug dosing regimens in specialized populations to model-based approaches in drug treatment among pediatrics. Readers will also find: A thorough introduction to considerations and regulatory affairs for clinical research in special populations Comprehensive explorations of drug disposition in geriatrics, patients with hepatic insufficiency, and patients with renal insufficiency Practical discussions of model-based pharmacokinetic approaches Complete treatments of artificial intelligence in drug development Perfect for practicing pharmacologists, pharmacists, and clinical chemists, Basics and Clinical Applications of Drug Disposition in Special Populations will also benefit medical professionals who provide medical and pharmaceutical care to special populations.

Translational Surgery

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Author : Adam E.M. Eltorai
language : en
Publisher: Elsevier
Release Date : 2023-03-22

Translational Surgery written by Adam E.M. Eltorai and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-03-22 with Science categories.

Translational Surgery covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. The reader will come to fully understand important concepts including case-control studies, prospective cohort studies, randomized trials, and reliability studies. Investigators will benefit from greater confidence in their ability to initiate and execute their own investigations, avoid common pitfalls in surgical research, and know what is needed for collaboration. Further, this title is an indispensable tool in grant writing and funding efforts. The practical, straightforward approach helps the translational research navigate challenging considerations in study design and implementation. The book provides valuable discussions of the critical appraisal of published studies in surgery, allowing the reader to learn how to evaluate the quality of such studies. Thus, they will improve at measuring outcomes; making effective use of all types of evidence in patient care. In short, this practical guidebook will be of interest to every surgeon or surgical researcher who has ever had a good clinical idea, but not the knowledge of how to test it. - Focuses on translational research in Surgery, covering the principles of evidence-based medicine and applying those principles to the design of translational investigations - Provides a practical, straightforward approach to help surgeons and researchers navigate challenging aspects of study design and implementation - Details valuable discussions on the critical appraisal of published studies in Surgery, allowing the reader to effectively use all types of evidence for patient care