Handbook of Statistics in Clinical Oncology

Handbook of Statistics in Clinical Oncology

Author: John Crowley

Publisher: CRC Press

ISBN: 9781439862018

Category: Mathematics

Page: 658

View: 446

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Many new challenges have arisen in the area of oncology clinical trials. New cancer therapies are often based on cytostatic or targeted agents, which pose new challenges in the design and analysis of all phases of trials. The literature on adaptive trial designs and early stopping has been exploding. Inclusion of high-dimensional data and imaging techniques have become common practice, and statistical methods on how to analyse such data have been refined in this area. A compilation of statistical topics relevant to these new advances in cancer research, this third edition of Handbook of Statistics in Clinical Oncology focuses on the design and analysis of oncology clinical trials and translational research. Addressing the many challenges that have arisen since the publication of its predecessor, this third edition covers the newest developments involved in the design and analysis of cancer clinical trials, incorporating updates to all four parts: Phase I trials: Updated recommendations regarding the standard 3 + 3 and continual reassessment approaches, along with new chapters on phase 0 trials and phase I trial design for targeted agents. Phase II trials: Updates to current experience in single-arm and randomized phase II trial designs. New chapters include phase II designs with multiple strata and phase II/III designs. Phase III trials: Many new chapters include interim analyses and early stopping considerations, phase III trial designs for targeted agents and for testing the ability of markers, adaptive trial designs, cure rate survival models, statistical methods of imaging, as well as a thorough review of software for the design and analysis of clinical trials. Exploratory and high-dimensional data analyses: All chapters in this part have been thoroughly updated since the last edition. New chapters address methods for analyzing SNP data and for developing a score based on gene expression data. In addition, chapters on risk calculators and forensic bioinformatics have been added. Accessible to statisticians and oncologists interested in clinical trial methodology, the book is a single-source collection of up-to-date statistical approaches to research in clinical oncology.

Handbook of Statistics in Clinical Oncology

Handbook of Statistics in Clinical Oncology

Author: John Crowley

Publisher: CRC Press

ISBN: 9781420027761

Category: Mathematics

Page: 640

View: 410

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A compendium of cutting-edge statistical approaches to solving problems in clinical oncology, Handbook of Statistics in Clinical Oncology, Second Edition focuses on clinical trials in phases I, II, and III, proteomic and genomic studies, complementary outcomes and exploratory methods. Cancer Forum called the first edition a

Handbook of Statistics in Clinical Oncology, Third Edition

Handbook of Statistics in Clinical Oncology, Third Edition

Author: John Crowley

Publisher: CRC Press

ISBN: 9781439862001

Category: Mathematics

Page: 657

View: 952

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Many new challenges have arisen in the area of oncology clinical trials. New cancer therapies are often based on cytostatic or targeted agents, which pose new challenges in the design and analysis of all phases of trials. The literature on adaptive trial designs and early stopping has been exploding. Inclusion of high-dimensional data and imaging techniques have become common practice, and statistical methods on how to analyse such data have been refined in this area. A compilation of statistical topics relevant to these new advances in cancer research, this third edition of Handbook of Statistics in Clinical Oncology focuses on the design and analysis of oncology clinical trials and translational research. Addressing the many challenges that have arisen since the publication of its predecessor, this third edition covers the newest developments involved in the design and analysis of cancer clinical trials, incorporating updates to all four parts: Phase I trials: Updated recommendations regarding the standard 3 + 3 and continual reassessment approaches, along with new chapters on phase 0 trials and phase I trial design for targeted agents. Phase II trials: Updates to current experience in single-arm and randomized phase II trial designs. New chapters include phase II designs with multiple strata and phase II/III designs. Phase III trials: Many new chapters include interim analyses and early stopping considerations, phase III trial designs for targeted agents and for testing the ability of markers, adaptive trial designs, cure rate survival models, statistical methods of imaging, as well as a thorough review of software for the design and analysis of clinical trials. Exploratory and high-dimensional data analyses: All chapters in this part have been thoroughly updated since the last edition. New chapters address methods for analyzing SNP data and for developing a score based on gene expression data. In addition, chapters on risk calculators and forensic bioinformatics have been added. Accessible to statisticians and oncologists interested in clinical trial methodology, the book is a single-source collection of up-to-date statistical approaches to research in clinical oncology.

Cancer Clinical Trials

Cancer Clinical Trials

Author: Stephen L. George

Publisher: CRC Press

ISBN: 9781315354330

Category: Mathematics

Page: 474

View: 878

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Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials. The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues addressed are also important for clinical trials in other settings. After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes.

Clinical Trials in Oncology, Third Edition

Clinical Trials in Oncology, Third Edition

Author: Stephanie Green

Publisher: CRC Press

ISBN: 9781439814499

Category: Mathematics

Page: 264

View: 850

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Studies that are unimpeachably thorough, non-political, unbiased, and properly designed... These are the standards to which everyone in clinical research aspires. Yet, the difficulties in designing trials and interpreting data are subtle and ever present. The new edition of Clinical Trials in Oncology provides a concise, nontechnical, and now thoroughly up-to-date review of methods and issues related to clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the major pitfalls that are seemingly inherent in these processes. This edition includes a new section that describes recent innovations in Phase I designs. Another new section on microarray data examines the challenges presented by massive data sets and describes approaches used to meet those challenges. As always, the authors use clear, lucid prose and a multitude of real-world trials as examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Although the book focuses on cancer trials, the issues and concepts are important in any clinical setting. Clinical Trials in Oncology, Second Edition works to improve the mutual understanding by clinicians and statisticians of the principles of clinical trials and helps them avoid the many hazards that can jeopardize the success of a trial.

Gunderson & Tepper’s Clinical Radiation Oncology, E-Book

Gunderson & Tepper’s Clinical Radiation Oncology, E-Book

Author: Joel E. Tepper

Publisher: Elsevier Health Sciences

ISBN: 9780323672474

Category: Medical

Page: 1648

View: 553

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A comprehensive, multidisciplinary resource for the entire radiation oncology team, Gunderson & Tepper’s Clinical Radiation Oncology, 5th Edition, thoroughly covers all aspects of this complex and dynamic field. Concise, templated chapters cover the basic biology of oncologic disease processes as well as updated treatment algorithms, the latest clinical guidelines, and state-of-the-art techniques and modalities. More than 1,000 images—detailed anatomy drawings, radiographic images, and more—provide outstanding visual support for every area of the text. Divides content into three distinct sections for quick access to information: Scientific Foundations, Techniques and Modalities, and Disease Sites. Disease Site chapters include overviews summarizing the most important issues and concluding discussions on controversies and problems. Features new and expanded content on molecular and cellular biology and its relevance in individualized treatment approaches, stereotactic radiation therapy, radiosurgery, proton therapy, biologic therapy, precision radiation therapy, targeted radiation, dosing guidelines for better quality of life and improved patient outcomes, and more. Includes new chapters on Radiation Physics: Particle Therapy, Interventional Radiology, Radiation Therapy in the Elderly, Palliative Care, Quality and Safety, and Immunotherapy with Radiotherapy. Provides guidance on single-modality and combined-modality approaches, as well as outcome data including disease control, survival, and treatment tolerance. Includes access to videos on Intraoperative Irradiation, Prostate Brachytherapy, Penile Brachytherapy, and Ocular Melanoma.

The Design of Studies for Medical Research

The Design of Studies for Medical Research

Author: David Machin

Publisher: John Wiley & Sons

ISBN: 9780470012987

Category: Medical

Page: 286

View: 316

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The same careful rigour imposed on the design of phase III randomised controlled trials is not always applied to medical research in other areas such as trials conducted at earlier stages of drug development. With the emphasis that is now placed on evidence-based medicine, such care and rigour will inevitably impact on these areas with increasing attention turned to the quality of design. This title describes what principles can be used to structure research effectively allowing for the required degree of accuracy. Written by two best selling authors, this book includes many examples from medical literature and will be of great value to all groups conducting studies at the interface of clinical and laboratory research.

Clinical Trial Biostatistics and Biopharmaceutical Applications

Clinical Trial Biostatistics and Biopharmaceutical Applications

Author: Walter R. Young

Publisher: CRC Press

ISBN: 9781482212198

Category: Mathematics

Page: 580

View: 969

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Since 1945, "The Annual Deming Conference on Applied Statistics" has been an important event in the statistics profession. In Clinical Trial Biostatistics and Biopharmaceutical Applications, prominent speakers from past Deming conferences present novel biostatistical methodologies in clinical trials as well as up-to-date biostatistical applications

A Handbook of Statistical Graphics Using SAS ODS

A Handbook of Statistical Graphics Using SAS ODS

Author: Geoff Der

Publisher: CRC Press

ISBN: 9781466599048

Category: Mathematics

Page: 244

View: 810

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Easily Use SAS to Produce Your GraphicsDiagrams, plots, and other types of graphics are indispensable components in nearly all phases of statistical analysis, from the initial assessment of the data to the selection of appropriate statistical models to the diagnosis of the chosen models once they have been fitted to the data. Harnessing the full gr

IASLC Thoracic Oncology E-Book

IASLC Thoracic Oncology E-Book

Author: Harvey Pass

Publisher: Elsevier Health Sciences

ISBN: 9780323527842

Category: Medical

Page: 960

View: 617

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Global experts, in conjunction with the International Association for the Study of Lung Cancer, bring you up to date with today’s best approaches to lung cancer diagnosis, treatment, and follow-up. IASLC Thoracic Oncology, 2nd Edition, keeps you abreast of the entire scope of this fast-changing field, from epidemiology to diagnosis to treatment to advocacy. Written in a straightforward, practical style for the busy clinician, this comprehensive, multidisciplinary title is a must-have for anyone involved in the care of patients with lung cancer and other thoracic malignancies. Offers practical, relevant coverage of basic science, epidemiology, pulmonology, medical and radiation oncology, surgery, pathology, palliative care, nursing, and advocacy. Provides authoritative guidance from the IASLC – the only global organization dedicated to the study of lung cancer. Includes new content on molecular testing, immunotherapy, early detection, staging and the IASLC staging system, surgical resection for stage I and stage II lung cancer, and stem cells in lung cancer. Features a new full-color design throughout, as well as updated diagnostic algorithms.

Textbook of Clinical Trials

Textbook of Clinical Trials

Author: David Machin

Publisher: John Wiley & Sons

ISBN: 9780470010150

Category: Mathematics

Page: 784

View: 883

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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.

Innovative Statistics in Regulatory Science

Innovative Statistics in Regulatory Science

Author: Shein-Chung Chow

Publisher: CRC Press

ISBN: 9781000710816

Category: Mathematics

Page: 530

View: 785

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Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in the review and approval process of regulatory submissions of pharmaceutical products. In addition, statistics in regulatory science are involved with the development of regulatory policy, guidance, and regulatory critical clinical initiatives related research. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are commonly encountered in regulatory science of pharmaceutical research and development including topics related to research activities, review of regulatory submissions, recent critical clinical initiatives, and policy/guidance development in regulatory science. Devoted entirely to discussing statistics in regulatory science for pharmaceutical development. Reviews critical issues (e.g., endpoint/margin selection and complex innovative design such as adaptive trial design) in the pharmaceutical development and regulatory approval process. Clarifies controversial statistical issues (e.g., hypothesis testing versus confidence interval approach, missing data/estimands, multiplicity, and Bayesian design and approach) in review/approval of regulatory submissions. Proposes innovative thinking regarding study designs and statistical methods (e.g., n-of-1 trial design, adaptive trial design, and probability monitoring procedure for sample size) for rare disease drug development. Provides insight regarding current regulatory clinical initiatives (e.g., precision/personalized medicine, biomarker-driven target clinical trials, model informed drug development, big data analytics, and real world data/evidence). This book provides key statistical concepts, innovative designs, and analysis methods that are useful in regulatory science. Also included are some practical, challenging, and controversial issues that are commonly seen in the review and approval process of regulatory submissions. About the author Shein-Chung Chow, Ph.D. is currently a Professor at Duke University School of Medicine, Durham, NC. He was previously the Associate Director at the Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA). Dr. Chow has also held various positions in the pharmaceutical industry such as Vice President at Millennium, Cambridge, MA, Executive Director at Covance, Princeton, NJ, and Director and Department Head at Bristol-Myers Squibb, Plainsboro, NJ. He was elected Fellow of the American Statistical Association and an elected member of the ISI (International Statistical Institute). Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Biostatistics Book Series, Chapman and Hall/CRC Press, Taylor & Francis, New York. Dr. Chow is the author or co-author of over 300 methodology papers and 30 books.