Oncology is a rapidly developing area in medical science. A significant investment in terms of costs, resources and time is required for oncology drug development. Understanding of the challenges at all stages is vital for a successful drug launching. The purpose of this book is to provide an overview and practical solutions to some of these challenges which are commonly observed during setting up, conducting and reporting of oncology studies. This book will cover a wide variety of topics related to common challenges in cancer clinical trials across different stages of drug development.
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.
Title consistently uses the evidence-based approach Evidence-based tables make documentation of care plan easy Interdisciplinary orientation – all aspects of patient care are covered Only book that involves experts from the entire range of cancer treatment in the fields of medical, surgical and radiation oncology Includes hot topics such as prevention and breast cancer Offers ground-breaking sections on the latest research and clinical applications in cancer survivorship Chapter on PET addresses imaging issues and how to get the best results Most comprehensive sections on the biology and epidemiology of cancer as compared to competitors
Phase I trials are a critical first step in the study of novel therapeutic approaches. They follow years of development in the laboratory, and precede Phase II and III trials where testing of the drug becomes more focused yet is conducted on a wider scale. The primary goals of Phase I trials are to identify the recommended dose, schedule and pharmacologic behaviour of new agents or new combinations of agents, and to describe the adverse effects of treatment. In cancer therapeutics, such studies have particular challenges. In general, because of the nature of the effects of treatment, most studies are conducted in patients with advanced malignancy, rather than in healthy volunteers. Furthermore, the endpoints of these trials are usually measures of adverse effects, but increasingly investigators are interested in assessment of the effects of new drugs on their molecular target. These factors render the design, conduct, analysis and ethical aspects of Phase I cancer clinicaltrials unique. This book provides a practical guide to Phase I cancer trials and is appropriate for oncology trainees or specialists interested in understanding cancer drug development. Topics covered include preclinical requirements needed for first-in-man investigation of new agents, principles and statistical design, ethical considerations of Phase I studies, pharmacokinetics, pharmacodynamics, and studies in special populations. Practical information on protocol development, study activation and conduct, as well as how to write reports of the results, are incorporated. Numerous appendices offer document templates to use in Phase I study development, and examples from actual Phase I trials are interspersed throughout, making this a true 'hands-on' guide. In an exciting time in cancer research, as the number and type of new potential anti-cancer drugs is increasing dramatically, this book provides much needed information on the first stage in getting a drug approved.
This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. Provides a guide to statistical methods and application in medical product development Assists readers in undertaking design and analysis of experiments at various stages of product development Features case studies throughout the book, as well as, SAS and R code
Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout
Practical and clinically focused, Abeloff’s Clinical Oncology is a trusted medical reference book designed to capture the latest scientific discoveries and their implications for cancer diagnosis and management of cancer in the most accessible manner possible. Abeloff’s equips everyone involved - from radiologists and oncologists to surgeons and nurses - to collaborate effectively and provide the best possible cancer care. Consult this title on your favorite e-reader, conduct rapid searches, and adjust font sizes for optimal readability. Select the most appropriate tests and imaging studies for cancer diagnosis and staging of each type of cancer, and manage your patients in the most effective way possible by using all of the latest techniques and approaches in oncology. Enhance your understanding of complex concepts with a color art program that highlights key points and illustrates relevant scientific and clinical problems. Stay at the forefront of the latest developments in cancer pharmacology, oncology and healthcare policy, survivorship in cancer, and many other timely topics. See how the most recent cancer research applies to practice through an increased emphasis on the relevance of new scientific discoveries and modalities within disease chapters. Streamline clinical decision making with abundant new treatment and diagnostic algorithms as well as concrete management recommendations. Take advantage of the collective wisdom of preeminent multidisciplinary experts in the field of oncology, including previous Abeloff’s editors John E. Niederhuber, James O. Armitage, and Michael B. Kastan as well as new editors James H. Doroshow from the National Cancer Institute and Joel E. Tepper of Gunderson & Tepper: Clinical Radiation Oncology. Quickly and effortlessly access the key information you need with the help of an even more user-friendly, streamlined format. Access the complete contents anytime, anywhere at Expert Consult, and test your mastery of the latest knowledge with 500 online multiple-choice review questions.
Learn rigorous statistical methods to ensure valid clinicaltrials This Second Edition of the critically hailed Clinical Trials buildson the text's reputation as a straightforward and authoritativepresentation of statistical methods for clinical trials. Readersare introduced to the fundamentals of design for various types ofclinical trials and then skillfully guided through the completeprocess of planning the experiment, assembling a study cohort,assessing data, and reporting results. Throughout the process, theauthor alerts readers to problems that may arise during the courseof the trial and provides commonsense solutions. The author bases the revisions and updates on his own classroomexperience, as well as feedback from students, instructors, andmedical and statistical professionals involved in clinical trials.The Second Edition greatly expands its coverage, ranging fromstatistical principles to controversial topics, includingalternative medicine and ethics. At the same time, it offers morepragmatic advice for issues such as selecting outcomes, samplesize, analysis, reporting, and handling allegations of misconduct.Readers familiar with the First Edition will discover completelynew chapters, including: * Contexts for clinical trials * Statistical perspectives * Translational clinical trials * Dose-finding and dose-ranging designs Each chapter is accompanied by a summary to reinforce the keypoints. Revised discussion questions stimulate critical thinkingand help readers understand how they can apply their newfoundknowledge, and updated references are provided to direct readers tothe most recent literature. This text distinguishes itself with its accessible and broadcoverage of statistical design methods--the crucial building blocksof clinical trials and medical research. Readers learn to conductclinical trials that produce valid qualitative results backed byrigorous statistical methods.
Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. Their primary goals are to identify the recommended dose, schedule and pharmacologic behavior of new agents or new combinations of agents and to describe the adverse effects of treatment. In cancer therapeutics, such studies have particular challenges. Due to the nature of the effects of treatment, most such studies are conducted in patients with advanced malignancy, rather than in healthy volunteers. Further, the endpoints of these trials are usually measures adverse effects rather than molecular target or anti-tumor effects. These factors render the design, conduct, analysis and ethical aspects of phase I cancer trials unique. As the only comprehensive book on this topic, Phase I Cancer Clinical Trials is a useful resource for oncology trainees or specialists interested in understanding cancer drug development. New to this edition are chapters on Phase 0 Trials and Immunotherapeutics, and updated information on the process, pitfalls, and logistics of Phase I Trials