Data-Based Radiation Oncology – Design of Clinical Trials PDF Download
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Author: Kerstin A. Kessel
Publisher: Frontiers Media SA
ISBN: 288945438X
Category : Cancer
Languages : en
Pages : 109
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Book Description
In radiation oncology as in many other specialties clinical trials are essential to investigate new therapy approaches. Usually, preparation for a prospective clinical trial is extremely time consuming until ethics approval is obtained. To test a new treatment usually many years pass before it can be implemented in the routine care. During that time, already new interventions emerge, new drugs appear on the market, technical & physical innovations are being implemented, novel biology driven concepts are translated into clinical approaches while we are still investigating the ones from years ago. Another problem is associated with molecular diagnostics and the growing amount of tumor specific biomarkers which allows for a better stratification of patient subgroups. On the other side, this may result in a much longer time for patient recruiting and consequently in larger multicenter trials. Moreover, all of the relevant data must be readily available for treatment decision making, treatment as well as follow-up, and ultimately for trial evaluation. This challenges even more for agreed standards in data acquisition, quality and management. How could we change the way currently clinical trials are performed in a way they are safe and ethically justifiable and speed up the initiation process, so we can provide new and better treatments faster for our patients? Further, while we rely on various quantitative information handling distributed, large heterogeneous amounts of data efficiently is very important. Thus data management becomes a strong focus. A good infrastructure helps to plan, tailor and conduct clinical trials in a way they are easy and quickly analyzable. In this research topic we want to discuss new ideas for intelligent trial designs and concepts for data management.
Author: Kerstin A. Kessel
Publisher: Frontiers Media SA
ISBN: 288945438X
Category : Cancer
Languages : en
Pages : 109
Get Book Here
Book Description
In radiation oncology as in many other specialties clinical trials are essential to investigate new therapy approaches. Usually, preparation for a prospective clinical trial is extremely time consuming until ethics approval is obtained. To test a new treatment usually many years pass before it can be implemented in the routine care. During that time, already new interventions emerge, new drugs appear on the market, technical & physical innovations are being implemented, novel biology driven concepts are translated into clinical approaches while we are still investigating the ones from years ago. Another problem is associated with molecular diagnostics and the growing amount of tumor specific biomarkers which allows for a better stratification of patient subgroups. On the other side, this may result in a much longer time for patient recruiting and consequently in larger multicenter trials. Moreover, all of the relevant data must be readily available for treatment decision making, treatment as well as follow-up, and ultimately for trial evaluation. This challenges even more for agreed standards in data acquisition, quality and management. How could we change the way currently clinical trials are performed in a way they are safe and ethically justifiable and speed up the initiation process, so we can provide new and better treatments faster for our patients? Further, while we rely on various quantitative information handling distributed, large heterogeneous amounts of data efficiently is very important. Thus data management becomes a strong focus. A good infrastructure helps to plan, tailor and conduct clinical trials in a way they are easy and quickly analyzable. In this research topic we want to discuss new ideas for intelligent trial designs and concepts for data management.
Author: William Kevin Kelly, DO
Publisher: Springer Publishing Company
ISBN: 0826168736
Category : Medical
Languages : en
Pages : 568
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Book Description
The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents—including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities. Now divided into six sections this revamped book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field; from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials. Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology. NEW TO THIS EDITION: Outlines how to design clinical trials with and without biomarker testing—including genomics-based “basket” trials, and adaptive trials for all phases during treatment and quality-of-life trials Includes new chapters on immunotherapy trials, radiation therapy trials, multi-arm trials, meta-analysis and adaptive design, use of genomics, dose modifications and use of ancillary treatments in investigational studies, establishing surrogate endpoints, practical issues with correlative studies, cost-effectiveness analysis, and more Comprehensively covers all regulatory aspects in the pursuit of global oncology trials Digital access to the ebook included
Author: Stephanie Green
Publisher: CRC Press
ISBN: 1439814481
Category : Mathematics
Languages : en
Pages : 266
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Book Description
The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data. Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial.
Author: Adam Eltorai
Publisher: Elsevier
ISBN: 0323884245
Category : Science
Languages : en
Pages : 736
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Book Description
Translational Radiation Oncology covers the principles of evidence-based medicine and applies them to the design of translational research. The book provides valuable discussions on the critical appraisal of published studies and recent developments in radiation oncology, allowing readers to learn how to evaluate the quality of such studies with respect to measuring outcomes and make effective use of all types of evidence. By reading this book, researchers have access to a practical approach to help them navigate challenging considerations in study design and implementation. It is a valuable resource for researchers, oncologists and members of biomedical field who want to understand more about translational research applied to the field of radiation oncology. Translational medicine serves as an indispensable tool in grant writing and funding efforts, so understanding how to apply its principles to research is necessary to guarantee that results will be impactful to patients. Provides a clear process for understanding, designing, executing and analyzing clinical and translational research Presents practical, step-by-step guidance to help readers take ideas from the lab to the bedside Written by a team of oncologists, radiologists and clinical research experts that fully cover translational research in radiation oncology
Author: Issam El Naqa
Publisher: CRC Press
ISBN: 0429840349
Category : Science
Languages : en
Pages : 415
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Book Description
This book explores outcome modeling in cancer from a data-centric perspective to enable a better understanding of complex treatment response, to guide the design of advanced clinical trials, and to aid personalized patient care and improve their quality of life. It contains coverage of the relevant data sources available for model construction (panomics), ranging from clinical or preclinical resources to basic patient and treatment characteristics, medical imaging (radiomics), and molecular biological markers such as those involved in genomics, proteomics and metabolomics. It also includes discussions on the varying methodologies for predictive model building with analytical and data-driven approaches. This book is primarily intended to act as a tutorial for newcomers to the field of outcome modeling, as it includes in-depth how-to recipes on modeling artistry while providing sufficient instruction on how such models can approximate the physical and biological realities of clinical treatment. The book will also be of value to seasoned practitioners as a reference on the varying aspects of outcome modeling and their current applications. Features: Covers top-down approaches applying statistical, machine learning, and big data analytics and bottom-up approaches using first principles and multi-scale techniques, including numerical simulations based on Monte Carlo and automata techniques Provides an overview of the available software tools and resources for outcome model development and evaluation, and includes hands-on detailed examples throughout Presents a diverse selection of the common applications of outcome modeling in a wide variety of areas: treatment planning in radiotherapy, chemotherapy and immunotherapy, utility-based and biomarker applications, particle therapy modeling, oncological surgery, and the design of adaptive and SMART clinical trials
Author: Stephen L. George
Publisher: CRC Press
ISBN: 1315354330
Category : Mathematics
Languages : en
Pages : 374
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Book Description
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.
Author: Allan Hackshaw
Publisher: Karger Medical and Scientific Publishers
ISBN: 1912776731
Category : Medical
Languages : en
Pages : 120
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Book Description
Written by leading experts, 'Fast Facts: Clinical Trials in Oncology' will enhance the reader’s ability to critically evaluate published evidence. Assuming little or no prior knowledge, the book sets out clearly the fundamental features of clinical trials. The key attributes of Phase I–III trials of pharmaceutical products are described, as are trials of surgical procedures, radiation therapy and advanced therapies. The processes and documentation required to set up and conduct a trial are outlined, and the authors describe how trial data and real-world evidence are used to improve care. Although this concise colorful book focuses on oncology, the principles apply equally to interventions in other areas of practice. It will prove invaluable to medical, pharmaceutical and allied health professionals who want, or need, an overview of how contemporary clinical trials are designed and conducted. Contents: • Fundamental features of clinical trials • Phase I trials • Phase II trials • Phase III trials • Trials of non-drug interventions • Setting up and conducting trials • Publishing trial results, changing clinical practice, and supporting evidence
Author: Board on Health Care Services
Publisher: National Academies Press
ISBN: 0309287278
Category : Medical
Languages : en
Pages : 111
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Book Description
The National Clinical Trials Network (NCTN) supported by the National Cancer Institute (NCI) has played an integral role in cancer research and in establishing the standard of care for cancer patients for more than 50 years. Formerly known as the NCI Clinical Trials Cooperative Group Program, the NCTN is comprised of more than 2,100 institutions and 14,000 investigators, who enroll more than 20,000 cancer patients in clinical trials each year across the United States and internationally. Recognizing the recent transformative advances in cancer research that necessitate modernization in how cancer clinical trials are run, as well as inefficiencies and other challenges impeding the national cancer clinical trials program, the NCI asked the IOM to develop a set of recommendations to improve the federally funded cancer clinical trials system. These recommendations were published in the 2010 report, A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program. In early 2011, the NCPF and the American Society of Clinical Oncology (ASCO) held a workshop in which stakeholders discussed the changes they planned to implement in response to the IOM goals and recommendations. Two years later, on February 11-12, 2013, in Washington, DC, the NCPF and ASCO reconvened stakeholders to report on the changes they have made thus far to address the IOM recommendations. At this workshop, representatives from the NCI, the NCTN, comprehensive cancer centers, patient advocacy groups, the Food and Drug Administration (FDA), industry, and other stakeholders highlighted the progress that has been made in achieving the goals for a reinvigorated national cancer clinical trials system. Implementing a National Cancer Clinical Trials System for the 21st Century is a summary of that workshop.
Author: Stephanie Green
Publisher: CRC Press
ISBN: 1420035304
Category : Mathematics
Languages : en
Pages : 281
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Book Description
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
Author: Wan Tang
Publisher: Springer Science & Business Media
ISBN: 1461443229
Category : Medical
Languages : en
Pages : 256
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Book Description
This volume covers classic as well as cutting-edge topics on the analysis of clinical trial data in biomedical and psychosocial research and discusses each topic in an expository and user-friendly fashion. The intent of the book is to provide an overview of the primary statistical and data analytic issues associated with each of the selected topics, followed by a discussion of approaches for tackling such issues and available software packages for carrying out analyses. While classic topics such as survival data analysis, analysis of diagnostic test data and assessment of measurement reliability are well known and covered in depth by available topic-specific texts, this volume serves a different purpose: it provides a quick introduction to each topic for self-learning, particularly for those who have not done any formal coursework on a given topic but must learn it due to its relevance to their multidisciplinary research. In addition, the chapters on these classic topics will reflect issues particularly relevant to modern clinical trials such as longitudinal designs and new methods for analyzing data from such study designs. The coverage of these topics provides a quick introduction to these important statistical issues and methods for addressing them. As with the classic topics, this part of the volume on modern topics will enable researchers to grasp the statistical methods for addressing these emerging issues underlying modern clinical trials and to apply them to their research studies.
