User Trial Report 5 55 Phase Ii
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Small Clinical Trials
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2001-02-01
Small Clinical Trials written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-02-01 with Medical categories.
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.
Cancer Treatment Reports
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Author :
language : en
Publisher:
Release Date : 1987
Cancer Treatment Reports written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1987 with Cancer categories.
Subject Index To Unclassified Astia Documents
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Author : Defense Documentation Center (U.S.)
language : en
Publisher:
Release Date : 1960
Subject Index To Unclassified Astia Documents written by Defense Documentation Center (U.S.) and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1960 with Industrial arts categories.
Cumulated Index Medicus
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Author :
language : en
Publisher:
Release Date : 2000
Cumulated Index Medicus written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000 with Medicine categories.
Case Studies In Innovative Clinical Trials
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Author : Kristine Broglio
language : en
Publisher: CRC Press
Release Date : 2023-11-27
Case Studies In Innovative Clinical Trials written by Kristine Broglio and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-27 with Medical categories.
Drug development is a strictly regulated area. As such, marketing approval of a new drug depends heavily, if not exclusively, on evidence generated from clinical trials. Drug development has seen tremendous innovation in science and technology that has revolutionized the treatment of some diseases. And yet, the statistical design and practical conduct of the clinical trials used to test new therapeutics for safety and efficacy have changed very little over the decades. Our approach to clinical trials is steeped in convention and tradition. The large, fixed, randomized controlled trial methods that have been the gold standard are well understood and expected by many trial stakeholders. However, this approach is not well suited to all aspects of modern drug development and the current competitive landscape. We now see new therapies that target a small fraction of the patient population, rare diseases with high unmet medical needs, and pediatric populations that must wait for years for new drug approvals from the time that therapies are approved in adults. Large randomized clinical trials are at best inefficient and at worst completely infeasible in many modern clinical settings. Advances in technology and data infrastructure call for innovations in clinical trial design. Despite advances in statistical methods, the availability of information, and computing power, the actual experience with innovative design in clinical trials across industry and academia is limited. This book will be an important showcase of the potential for these innovative designs in modern drug development and will be an important resource to guide those who wish to undertake them for themselves. This book is ideal for professionals in the pharmaceutical industry and regulatory agencies, but it will also be useful to academic researchers, faculty members, and graduate students in statistics, biostatistics, public health, and epidemiology due to its focus on innovation. Key Features: Is written by pharmaceutical industry experts, academic researchers, and regulatory reviewers; this is the first book providing a comprehensive set of case studies related to statistical methodology, implementation, regulatory considerations, and communication of complex innovative trial design. Has a broad appeal to a multitude of readers across academia, industry, and regulatory agencies. Each contribution is a practical case study that can speak to the benefits of an innovative approach but also balance that with the real-life challenges encountered. A complete understanding of what is actually being done in modern clinical trials will broaden the reader’s capabilities and provide examples to first mimic and then customize and expand upon when exploring these ideas on their own.
Stereotactic Radiosurgery And Stereotactic Body Radiation Therapy
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Author : Daniel M. Trifiletti
language : en
Publisher: Springer
Release Date : 2019-06-27
Stereotactic Radiosurgery And Stereotactic Body Radiation Therapy written by Daniel M. Trifiletti and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-06-27 with Medical categories.
This book is a comprehensive review of stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT): its physics, clinical evidence, indications, and future directions. The utilization of stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) is increasing internationally because of several factors. First, it offers patients a local treatment option that has demonstrated effectiveness similar to traditional surgery without the morbidity of general anesthesia and open surgical resection. Second, recent advancements in the quality of scientific evidence supporting a SRS or SBRT-containing approach in patients continues to evolve and demonstrate favorable disease-specific outcomes with little, if any, toxicity in various anatomic disease sites and for various conditions including cancer, benign tumors, and other psychiatric and neurologic conditions. Third, and most provocatively, is the notion that definitive local therapy (i.e. SRS or SBRT) in patients with cancer can boost the immune system to fight cancer in other sites throughout the body. While traditional medical knowledge would suggest that all patients with metastatic cancer are incurable, there is a mounting body of evidence that there is a subset of these patients that can be cured with definitive SRS or SBRT. This volume thus delves into each of these benefits and aspects of treatment, guiding physicians to the best treatment plan for their patients. Expert, international authors provide guidelines for SRS and SBRT use by clinicians. Chapters are divided into six main sections: Radiobiology of Radiosurgery and Stereotactic Body Radiation Therapy, Intracranial Radiosurgery Technique, Intracranial Radiosurgery by Indication, Stereotactic Body Radiation Therapy Technique, Stereotactic Body Radiation Therapy by Indication, The Future of Radiosurgery and SBRT. Overall physics are explained, as well as specific considerations for particular surgical tools (including the Leksell Gamma Knife and Accuray CyberKnife), techniques (including fractionated and charged particle radiosurgery), and anatomic sites (including brain metastases, pituitary tumors, and the prostate). Detailed images and charts enhance the chapters. This book provides physicians with a single, practical resource incorporating both of these broad categories of treatment, SRS and SBRT, and better defines the current role and the direction of radiosurgery.
Treatment Of Cancer Fifth Edition
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Author : Pat Price
language : en
Publisher: CRC Press
Release Date : 2008-05-30
Treatment Of Cancer Fifth Edition written by Pat Price and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-05-30 with Medical categories.
Since the first edition was published in 1982, Treatment of Cancer has become a standard text for postgraduate physicians in the UK and beyond, providing all information necessary for modern cancer management in one comprehensive but accessible volume. By inviting experts from a number of disciplines to share their knowledge, the editors have succeeded in delivering a truly integrated approach to the care of the patient with cancer. This fifth edition adopts the successful structure of previous editions, whilst being thoroughly revised and updated, and with several completely new chapters, covering important topics such as drug development, cancer prevention, and economics of cancer care, as well as treatments such as radioimmunotherapy, biological therapies and antibody therapy. Part One considers the scientific basis and fundamental principles underlying cancer treatment and examines the likely developments that will occur over the next decade at the leading edge of oncology. Part Two is divided into two sections; the first covering general issues of cancer management, including planning techniques, concomitent chemoradiotherapy, surgical oncology and palliative care; and the second using a system-based approach to cover the clinical aspects and management plans for the whole spectrum of malignant disease. Treatment of Cancer surpasses other oncology texts in condensing the essential information for exemplary cancer care into one readable and accessible guide, and will be an invaluable addition to the bookshelves of the busy oncologist in training or in practice.
Gastrointestinal Oncology
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Author : James L. Abbruzzese
language : en
Publisher: Oxford University Press
Release Date : 2003-10-23
Gastrointestinal Oncology written by James L. Abbruzzese and has been published by Oxford University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-10-23 with Medical categories.
In 74 chapters, Gastrointestinal Oncology brings together a diverse group of specialists to provide the most authoritative, up-to-date and encyclopedic volume currently available on the subject. The first part of this text introduces a series of concepts and topics taht are important to gastrointestinal malignancies in general. These topics include epidemiologic principles, prevention, screening, familial GI cancers, developmental and molecular biology, pathobiology, general therapeutic principles, emerging therapies, and palliative care. The second part of the book covers each of the specific cancers affecting the human gastrointestinal tract. These chapters are introduced by state of the art discussions outlining our current understanding of the pathobiology and molecular biology relevant to each cancer. Subsequent sections describe the multidisciplinary management of specific clinical situations. By organizing the treatment-related chapters around clinical scenarios, the reader will readily find the information necessary to effectively manage the complex clinical situations encountered by patients with gastrointestinal malignancies.
Cummings Otolaryngology E Book
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Author : Paul W. Flint
language : en
Publisher: Elsevier Health Sciences
Release Date : 2020-04-22
Cummings Otolaryngology E Book written by Paul W. Flint and has been published by Elsevier Health Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04-22 with Medical categories.
The most comprehensive, multi-disciplinary text in the field, Cummings Otolaryngology: Head and Neck Surgery, 7th Edition, provides detailed, practical answers and easily accessible clinical content on the complex issues that arise for otolaryngologists at all levels, across all subspecialties. This award-winning text is a one-stop reference for all stages of your career—from residency and board certification through the challenges faced in daily clinical practice. Updated content, new otology editor Dr. Howard W. Francis, and new chapters and videos ensure that this 7th Edition remains the definitive reference in today’s otolaryngology. Brings you up to date with the latest minimally invasive procedures, recent changes in rhinology, and new techniques and technologies that are shaping patient outcomes. Contains 12 new chapters, including Chronic Rhinosinusitis, Facial Pain, Geriatric Otology, Middle Ear Endoscopic Surgery, Pediatric Speech Disorders, Pediatric Cochlear Implantation, Tongue-Ties and Lip Ties, Laryngotracheal Clefts, and more. Covers recent advances and new approaches such as the Draf III procedure for CRS affecting the frontal recess, endoscopic vidian and posterior nasal neurectomy for non-allergic rhinitis, and endoscopic approaches for sinonasal and orbital tumors, both extra- and intraconal. Provides access to 70 key indicator (Accreditation Council for Graduate Medical Education Key Indicator Procedures), and surgical videos – an increase of 43% over the previous edition. Offers outstanding visual support with 4,000 high-quality images and hundreds of quick-reference tables and boxes.
Hemostasis And Thrombosis
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Author :
language : en
Publisher:
Release Date : 1972
Hemostasis And Thrombosis written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1972 with Blood coagulation disorders categories.
Monthly, with annual cumulation. Recurring bibliography from MEDLARS data base. Index medicus format. Entries arranged under subject, review, and author sections. Subject, author indexes.