Clinical Trials Design In Operative And Non Operative Invasive Procedures
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Clinical Trials Design In Operative And Non Operative Invasive Procedures
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Author : Kamal M.F. Itani
language : en
Publisher: Springer
Release Date : 2017-05-16
Clinical Trials Design In Operative And Non Operative Invasive Procedures written by Kamal M.F. Itani and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-05-16 with Medical categories.
The aim of this text is to provide the framework for building a clinical trial as it pertains to operative and non operative invasive procedures, how to get it funded and how to conduct such a trial up to publication of results The text provides all details of building a scientifically and ethically valid proposal, including how to build the infrastructure for a clinical trial and how to move it forward through various funding agencies. The text also presents various types of clinical trials, the use of implantable devices and FDA requirements, and adjuncts to clinical trials and interaction with industry Clinical Trials Design in Invasive Operative and Non Operative Procedures will be of interest to all specialists of surgery, anesthesiologists, interventional radiologists, gastroenterologists, cardiologists, and pulmonologists
Clinical Trials
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Author : Timothy M. Pawlik
language : en
Publisher: Springer Nature
Release Date : 2020-03-10
Clinical Trials written by Timothy M. Pawlik and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-03-10 with Medical categories.
This extensively revised second edition is a unique and portable handbook focusing on clinical trials in surgery. It includes new educational materials addressing the rapid evolution of novel research methodologies in basic science, clinical and educational research. The underlying principles of clinical trials, trial design, the development of a study cohort, statistics, data safety, data monitoring, and trial publication for device and drug trials are also discussed. Clinical Trials provides a comprehensive resource on clinical trials in surgery and describes all the stages of a clinical trial from generating a hypothesis through to trial publication and is a valuable resource for all practicing and trainee academic surgeons.
Clinical Trial Project Management
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Author : Ashok Kumar Peepliwal
language : en
Publisher: Elsevier
Release Date : 2023-11-15
Clinical Trial Project Management written by Ashok Kumar Peepliwal and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-15 with Business & Economics categories.
Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials, in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing etc. covering entire clinical trial process of conductance. In addition to that the author also incorporated the clinical trial approval process of USFDA, EMA, and JAPAN to conduct the clinical trials. - Covers how to conduct clinical trials in detail - Present useful, basic, and advanced statistical tools - Provides real-time project management methods like Program Evaluation Review Technique (PERT) and Critical Path Method (CPM) to manage complex projects are described in the book
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
Dosage Form Design Parameters
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Author :
language : en
Publisher: Academic Press
Release Date : 2018-07-25
Dosage Form Design Parameters written by and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-07-25 with Medical categories.
Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. - Examines the history and recent developments in drug dosage forms for pharmaceutical sciences - Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism - Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design
Essentials Of Clinical Research
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Author : Stephen P. Glasser
language : en
Publisher: Springer
Release Date : 2014-06-02
Essentials Of Clinical Research written by Stephen P. Glasser and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-06-02 with Medical categories.
In its extensively revised and updated Second Edition, this book provides a solid foundation for readers interested in clinical research. Discussion encompasses genetic, pharmacoepidemiologic and implementation research. All chapters have been updated with new information and many new tables have been added to elucidate key points. The book now offers discussion on how to handle missing data when analyzing results, and coverage of Adaptive Designs and Effectiveness Designs and new sections on Comparative Effectiveness Research and Pragmatic Trials. Chapter 6 includes new material on Phase 0 Trials, expanded coverage of Futility Trials, a discussion of Medical Device approval, Off Label Drug use and the role of the FDA in regulating advertising. Additional new information includes the role of pill color and shape in association with the placebo effect and an examination of issues surrounding minority recruitment. The final chapter offers a new section on manuscript preparation along with a discussion of various guidelines being adopted by journals: CONSORT, STROBE, PRISMA, MOOSE and others; and coverage of Conflicts of Interest, Authorship, Coercive Citation, and Disclosures in Industry-Related Associations. Building on the strengths of its predecessor in its comprehensive approach and authoritative advice, the new edition offers more of what has made this book a popular, trusted resource for students and working researchers alike.
Difficult Decisions In Surgical Ethics
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Author : Vassyl A. Lonchyna
language : en
Publisher: Springer Nature
Release Date : 2022-01-11
Difficult Decisions In Surgical Ethics written by Vassyl A. Lonchyna and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-01-11 with Medical categories.
This book provides a detailed guide to the ethical considerations involved when making decisions in surgery. Chapters feature a uniform format, which feature a case that represents a real-life problem, discussion of the medical indications of that issue, the latest available medical solutions, and related ethical considerations. In some cases, more in-depth debate is provided on why a particular decision should or should not be made based-upon ethical principles. Information boxes containing key statements and relevant data in clear easy-to-digest tables facilitates the reader in being able to assimilate the most important points covered in each chapter. Difficult Decisions in Surgical Ethics: An Evidence-Based Approach is a thorough review of ethical considerations in a range of surgical scenarios encompassing both adult and pediatric topics, training surgical residents, ethical care during a pandemic, critical care, palliative care, sensitivity to religious and ethnic mores, clinical research, and innovation. It is intended to be a vital resource for practicing and trainee surgeons seeking a comprehensive up-to-date resource on ethical topics in surgical practice. The work is part of the Difficult Decisions in Surgery series covering a range of surgical specialties.
Introduction To Surgical Trials
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Author : Stephen Lyman
language : en
Publisher: Springer Nature
Release Date : 2025-02-25
Introduction To Surgical Trials written by Stephen Lyman and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-02-25 with Medical categories.
Filling a gap in literature, this book examines surgical trials with a special focus on the underlying principles, challenges, and best practices to successfully conduct rigorous surgical research. While randomized controlled trials (RCTs) remain the gold standard for evaluation of the safety and efficacy of most medical interventions, they are particularly difficult to implement successfully in the context of surgery. As a result, recruitment rates are often extremely low, crossover from non-operative to operative is common, and patients randomly allocated to surgery often simply decline to have the procedure. All of these challenges call into question the recent generalizability and fundamental quality of traditional surgical RCTs. As such, this book explores advanced alternative trial design methods and describes the current regulatory environment around the world. Designed as a practical guide, it is a valuable tool for surgeons, epidemiologist and biostatisticians involved in this challenging field.
Spine Disorders
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Author : J. D. Bartleson
language : en
Publisher: Cambridge University Press
Release Date : 2009-07-23
Spine Disorders written by J. D. Bartleson and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-07-23 with Medical categories.
An essential information source for all healthcare providers treating patients with cervical, thoracic and lumbar spine disease.
Textbook Of Clinical Trials
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Author : David Machin
language : en
Publisher: John Wiley & Sons
Release Date : 2007-01-11
Textbook Of Clinical Trials written by David Machin 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 2007-01-11 with Mathematics categories.
Now published in its Second Edition, the Textbook of Clinical Trials offers detailed coverage of trial methodology in diverse areas of medicine in a single comprehensive volume. Praise for the First Edition: "... very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas." BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2, February 2005 The book’s main concept is to describe the impact of clinical trials on the practice of medicine. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. The sections provide a background to the disease area and general clinical trial methodology before concentrating on particular problems experienced in that area. Specific examples are used throughout to address these issues. The Textbook of Clinical Trials, Second Edition: Highlights the various ways clinical trials have influenced the practice of medicine in many therapeutic areas Describes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fields Additional therapeutic areas are included in this Second Edition to fill gaps in the First Edition as the number and complexity of trials increases in this rapidly developing area Newly covered or updated in the Second Edition: general surgery, plastic surgery, aesthetic surgery, palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal, thyroid and urological cancers, as well as a chapter on the Cochrane network An invaluable resource for pharmaceutical companies, the Textbook of Clinical Trials, Second Edition appeals to those working in contract research organizations, medical departments and in the area of public health and health science alike.