Download or read book Clinical Trials Design in Operative and Non Operative Invasive Procedures written by Kamal M.F. Itani and published by Springer. This book was released on 2017-05-16 with total page 485 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Clinical Trials written by Timothy M. Pawlik and published by Springer Nature. This book was released on 2020-03-10 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
Download or read book Clinical Research Methods for Surgeons written by David F. Penson and published by Springer Science & Business Media. This book was released on 2007-11-06 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: With his keen analytical mind and penchant for organization, Charles Darwin would have made an excellent clinical investigator. Unfortunately for surgery, his early exposure at Edinburgh to the brutality of operations in 1825 convinced him to reject his father’s plan for his career and pursue his interest in nature. His subsequent observations of how environmental pressures shaped the development of new species provided the essential mechanism to explain evolution and the disappearance of those species that failed to adapt. Today, surgeons face the same reality as new technology, progressive regulation by government and payers, medico-legal risks, and public demands for proof of performance force changes in behavior that our predecessors never imagined. We know that surgeons have always prided themselves on accurate documentation of their results, including their complications and deaths, but observational studies involving a single surgeon or institution have given way to demands for controlled interventional trials despite the inherent difficulty of studying surgical patients by randomized, blinded techniques. That is why this book is so timely and important. In a logical and comprehensive approach, the authors have assembled a group of experienced clinical scientists who can demonstrate the rich variety of techniques in epidemiology and statistics for reviewing existing publications, structuring a clinical study, and analyzing the resulting data.
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Download or read book Design Execution and Management of Medical Device Clinical Trials written by Salah M. Abdel-aleem and published by John Wiley & Sons. This book was released on 2009-09-08 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes: Qualification and selection of investigators Study monitoring visits Definitions and reporting procedures for adverse events The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints The roles and responsibilities of all members of a clinical research team The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic. Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices.
Download or read book Success in Academic Surgery Clinical Trials written by Timothy M. Pawlik and published by Springer Science & Business Media. This book was released on 2013-11-04 with total page 197 pages. Available in PDF, EPUB and Kindle. Book excerpt: Surgical education is a rapidly expanding area of surgical research and career interest, and as the Association for Academic Surgery (AAS) Fall Courses (www.aasurg.org) and International courses offer more and more specialty tracking there is a greater need for an accompanying textbook to supplement the material presented in the courses.
Download or read book Clinical Trial Project Management written by Ashok Kumar Peepliwal and published by Elsevier. This book was released on 2023-11-15 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Clinical Research for Surgeons written by Mohit Bhandari and published by Thieme. This book was released on 2009 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new series is designed as a practical aid in planning and conducting clinical research, particularly as it applies in orthopedic surgery. In the first book of this series, the basic principles of evidence-based medicine and surgery are covered, and these principles are applied to the design of research studies. The reader of this book will come to fully understand concepts such as case-control study, prospective cohort study, randomized trial, reliability study, and many more. Discussions of the critical appraisal of published clinical studies are provided, allowing the reader to hone his or her ability to evaluate the quality of such studies with respect to measuring outcomes. Further volumes in this series will cover in more detail such topics as planning the trials, regulatory issues, strategies for obtaining funding, putting together the research team, the use of appropriate statistics, and more.
Download or read book Designs for Clinical Trials written by David Harrington and published by Springer Science & Business Media. This book was released on 2011-10-09 with total page 213 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book will examine current issues and controversies in the design of clinical trials, including topics in adaptive and sequential designs, the design of correlative genomic studies, the design of studies in which missing data is anticipated. Each chapter will be written by an expert conducting research in the topic of that chapter. As a collection, the chapters would be intended to serve as a guidance for statisticians designing trials.
Download or read book Translational Surgery written by and published by Elsevier. This book was released on 2023-03-22 with total page 770 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Dosage Form Design Parameters written by and published by Academic Press. This book was released on 2018-07-25 with total page 816 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Design Issues and Challenges in Clinical Trials with a Surgical and Non surgical Comparison written by Loretta Davies and published by . This book was released on 2019 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Design and Management of Medical Device Clinical Trials written by Salah M. Abdel-aleem and published by John Wiley & Sons. This book was released on 2011-09-09 with total page 269 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It discusses key obstacles such as challenges to patient recruitment, investigator and study site selection, and dealing with compliance issues. Through practical examples, professionals working with medical device clinical trials will discover the appropriate steps to take.
Download or read book Evidence Based Surgery written by Achilles Thoma and published by Springer. This book was released on 2019-03-25 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this book specifically is to teach surgeons (academic or community), surgical fellows and surgical residents regardless of the surgical specialty, the skills to appraise what they read in the surgical literature. Surgeons need to be able to understand what they read before applying the conclusions of a surgical article to their practice. As most surgeons do not have the extra training in health research methodology, understanding how the research was done, how to interpret the results and finally deciding to apply them to the patient level is indeed a difficult task. Chapters explain the methodological issues pertaining to the various study designs reported in the surgical literature. Most chapters begin with a clinical scenario with uncertain course of action with which most surgeons are struggling. Readers are taught how to search the literature for the best evidence that will answer the surgical problem under discussion. An identified article that seems relevant to the problem you are investigating can be appraised by addressing 3 key questions: 1). Is the study I am reading valid? 2). What are the results of this study? 3). Can I apply these results to my patients? While the primary goal of Evidence-Based Surgery is to teach surgeons how to appraise the surgical literature, an added benefit is that the concepts explained here may help research-minded surgeons produce higher quality research.
Download or read book Randomized Clinical Trials of Nonpharmacological Treatments written by Isabelle Boutron and published by CRC Press. This book was released on 2016-04-19 with total page 397 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nonpharmacological treatments include a wide variety of treatments such as surgery, technical procedures, implantable and non-implantable devices, rehabilitation, psychotherapy, and behavioral interventions. Unlike pharmacological treatments, these have no specific requirements for approval. Consequently, they can be widely proposed in clinical pra
Download or read book The Clinical Trial Protocol written by Sue Fitzpatrick and published by Inst of Clinical Research. This book was released on 2005-12 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt:
