Novel Designs of Early Phase Trials for Cancer Therapeutics PDF Download
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Author: Shivaani Kummar
Publisher: Academic Press
ISBN: 0128125705
Category : Medical
Languages : en
Pages : 235
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Book Description
Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials. Brings a comprehensive review and recommendations for new clinical trial designs for modern cancer therapeutics Provides the reader with a better understanding on how to design and implement early phase oncology trials Presents a better and updated understanding of the process of developing new treatments for cancer, the exciting scientific advances and how they are informing drug development
Author: Shivaani Kummar
Publisher: Academic Press
ISBN: 0128125705
Category : Medical
Languages : en
Pages : 235
Get Book Here
Book Description
Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials. Brings a comprehensive review and recommendations for new clinical trial designs for modern cancer therapeutics Provides the reader with a better understanding on how to design and implement early phase oncology trials Presents a better and updated understanding of the process of developing new treatments for cancer, the exciting scientific advances and how they are informing drug development
Author: Sandip Pravin Patel
Publisher: Springer
ISBN: 3319637576
Category : Medical
Languages : en
Pages : 336
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Book Description
This volume, a state-of-the-art review of early phase clinical trials for cancer immunotherapy, discusses biomarker selection, combinatorial strategies and their safety or toxicity, determination of Phase 2 dosing, endpoints in the setting of radiographic pseudoprogression, histology selection, and novel immunotherapeutics as they relate to early phase cancer immunotherapy.
Author: National Cancer Institute (U.S.)
Publisher:
ISBN:
Category : Breast
Languages : en
Pages : 20
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Book Description
Author: Ying Yuan
Publisher: CRC Press
ISBN: 1498709567
Category : Mathematics
Languages : en
Pages : 310
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Book Description
Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. Bayesian Designs for Phase I–II Clinical Trials describes how phase I–II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity.
Author: Haidong Dong
Publisher: Springer Nature
ISBN: 3031594754
Category :
Languages : en
Pages : 228
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Book Description
Author: Timothy A. Yap
Publisher: Springer Nature
ISBN: 3030476820
Category : Medical
Languages : en
Pages : 352
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Book Description
This book provides a detailed review of how oncology drug development has changed over the past decade, and serves as a comprehensive guide for the practicalities in setting up phase I trials. The book covers strategies to accelerate the development of novel antitumor compounds from the laboratory to clinical trials and beyond through the use of innovative mechanism-of-action pharmacodynamic biomarkers and pharmacokinetic studies. The reader will learn about all aspects of modern phase I trial designs, including the incorporation of precision medicine strategies, and approaches for rational patient allocation to novel anticancer therapies. Circulating biomarkers to assess mechanisms of response and resistance are changing the way we are assessing patient selection and are also covered in this book. The development of the different classes of antitumor agents are discussed, including chemotherapy, molecularly targeted agents, immunotherapies and also radiotherapy. The authors also discuss the lessons that the oncology field has learnt from the development of hematology-oncology drugs and how such strategies can be carried over into therapies for solid tumors. There is a dedicated chapter that covers the specialized statistical approaches necessary for phase I trial designs, including novel Bayesian strategies for dose escalation. This volume is designed to help clinicians better understand phase I clinical trials, but would also be of use to translational researchers (MDs and PhDs), and drug developers from academia and industry interested in cancer drug development. It could also be of use to phase I trial study coordinators, oncology nurses and advanced practice providers. Other health professionals interested in the treatment of cancer will also find this book of great value.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309163358
Category : Medical
Languages : en
Pages : 151
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Book Description
An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309457971
Category : Medical
Languages : en
Pages : 145
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Book Description
Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.
Author: Haidong Dong
Publisher: Springer
ISBN: 3319706225
Category : Medical
Languages : en
Pages : 164
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Book Description
This book provides patients and their physicians (especially “non-oncologist” health care providers) with a clear and concise introduction to cancer immunotherapy, which, unlike traditional forms of cancer therapy, acts by boosting the patient’s own immune system to fight cancer. The unique features of cancer immunotherapy make its management, monitoring and side-effects different from those of traditional cancer therapy. Especially novel are the side effects of cancer immunotherapy, necessitating greater awareness for both patients and physicians in order to minimize complications of therapy. The patient-friendly, concise, easy-to-understand, and up-to-date knowledge presented in this book will inform patients about the benefits and risks of cancer immunotherapy, and help them and their care providers to understand how immunotherapy would control their unique disease. Researchers and academic professionals in the field of cancer immunotherapy will also find clear and useful information to help them communicate with patients or address unresolved problems. Some key features of the book are: Expertise. All editors and authors are scientists and oncologists specializing in cancer immunotherapy, and are involved in scientific discovery from the early stage of immune-checkpoint inhibitors to today’s daily patient care. Their insights, expertise and experience guarantee the high quality and authority in the science, medicine and practice of cancer immunotherapy. Patient-friendly. This book is written for cancer patients in order to meet their needs when considering immunotherapy. As an educational tool, this book will help the reader balance the risks and benefits based on both science and clinical facts, and therefore to make the best choice in receiving or withdrawing from immunotherapy. Disease Specificity. Cancer is a complicated disease involving multiple stages and pathology. Its response to immunotherapy is individualized and varies depending on cancer types. The authors’ expertise in treating different types of cancers, including melanoma, lung, kidney, bladder, and lymphoma, provides disease-specific insights in applying immunotherapy to each disease.
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.
