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Early Phase Cancer Immunotherapy
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Book Synopsis Novel Designs of Early Phase Trials for Cancer Therapeutics by : Shivaani Kummar
Download or read book Novel Designs of Early Phase Trials for Cancer Therapeutics written by Shivaani Kummar and published by Academic Press. This book was released on 2018-05-22 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Early Phase Cancer Immunotherapy by : Sandip Pravin Patel
Download or read book Early Phase Cancer Immunotherapy written by Sandip Pravin Patel and published by Springer. This book was released on 2017-11-03 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Phase I Oncology Drug Development by : Timothy A. Yap
Download or read book Phase I Oncology Drug Development written by Timothy A. Yap and published by Springer Nature. This book was released on 2020-09-16 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Participation in Clinical Trials of the Treatment of Early-stage Breast Cancer at the National Cancer Institute by : National Cancer Institute (U.S.)
Download or read book Participation in Clinical Trials of the Treatment of Early-stage Breast Cancer at the National Cancer Institute written by National Cancer Institute (U.S.) and published by . This book was released on 1981 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Bayesian Designs for Phase I-II Clinical Trials by : Ying Yuan
Download or read book Bayesian Designs for Phase I-II Clinical Trials written by Ying Yuan and published by CRC Press. This book was released on 2017-12-19 with total page 233 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis The Basics of Cancer Immunotherapy by : Haidong Dong
Download or read book The Basics of Cancer Immunotherapy written by Haidong Dong and published by Springer. This book was released on 2018-01-05 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Dose Finding by the Continual Reassessment Method by : Ying Kuen Cheung
Download or read book Dose Finding by the Continual Reassessment Method written by Ying Kuen Cheung and published by CRC Press. This book was released on 2011-03-29 with total page 207 pages. Available in PDF, EPUB and Kindle. Book excerpt: As clinicians begin to realize the important role of dose-finding in the drug development process, there is an increasing openness to "novel" methods proposed in the past two decades. In particular, the Continual Reassessment Method (CRM) and its variations have drawn much attention in the medical community, though it has yet to become a commonplace tool. To overcome the status quo in phase I clinical trials, statisticians must be able to design trials using the CRM in a timely and reproducible manner. A self-contained theoretical framework of the CRM for researchers and graduate students who set out to learn and do research in the CRM and dose-finding methods in general, Dose Finding by the Continual Reassessment Method features: Real clinical trial examples that illustrate the methods and techniques throughout the book Detailed calibration techniques that enable biostatisticians to design a CRM in timely manner Limitations of the CRM are outlined to aid in correct use of method This book supplies practical, efficient dose-finding methods based on cutting edge statistical research. More than just a cookbook, it provides full, unified coverage of the CRM in addition to step-by-step guidelines to automation and parameterization of the methods used on a regular basis. A detailed exposition of the calibration of the CRM for applied statisticians working with dose-finding in phase I trials, the book focuses on the R package ‘dfcrm’ for the CRM and its major variants. The author recognizes clinicians’ skepticism of model-based designs, and addresses their concerns that the time, professional, and computational resources necessary for accurate model-based designs can be major bottlenecks to the widespread use of appropriate dose-finding methods in phase I practice. The theoretically- and empirically-based methods in Dose Finding by the Continual Reassessment Method will lessen the statistician’s burden and encourage the continuing development and implementation of model-based dose-finding methods.
Book Synopsis Small Clinical Trials by : Institute of Medicine
Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Transforming Clinical Research in the United States by : Institute of Medicine
Download or read book Transforming Clinical Research in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-22 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 13 :0309457971 Total Pages :145 pages Book Rating :4.3/5 (94 download)
Book Synopsis The Drug Development Paradigm in Oncology by : National Academies of Sciences, Engineering, and Medicine
Download or read book The Drug Development Paradigm in Oncology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-02-12 with total page 145 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Chimeric Antigen Receptor T-Cell Therapies for Cancer E-Book by : Daniel W. Lee
Download or read book Chimeric Antigen Receptor T-Cell Therapies for Cancer E-Book written by Daniel W. Lee and published by Elsevier Health Sciences. This book was released on 2019-11-30 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: From patient referral to post-therapy management, Chimeric Antigen Receptor (CAR) T-Cell Therapies for Cancer: A Practical Guide presents a comprehensive view of CAR modified T-cells in a concise and practical format. Providing authoritative guidance on the implementation and management of CAR T-cell therapy from Drs. Daniel W. Lee and Nirali N. Shah, this clinical resource keeps you up to date on the latest developments in this rapidly evolving area. Covers all clinical aspects, including patient referral, toxicities management, comorbidities, bridging therapy, post-CAR monitoring, and multidisciplinary approaches to supportive care. Includes key topics on associated toxicities such as predictive biomarkers, infections, and multidisciplinary approaches to supportive care. Presents current knowledge on FDA approved CAR T-cell products as well as developments on the horizon. Editors and authors represent leading investigators in academia and worldwide pioneers of CAR therapy.
Book Synopsis Statistical Approaches in Oncology Clinical Development by : Satrajit Roychoudhury
Download or read book Statistical Approaches in Oncology Clinical Development written by Satrajit Roychoudhury and published by CRC Press. This book was released on 2018-12-07 with total page 237 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Approaches in Oncology Clinical Development : Current Paradigm and Methodological Advancement presents an overview of statistical considerations in oncology clinical trials, both early and late phase of development. It illustrates how novel statistical methods can enrich the design and analysis of modern oncology trials. The authors include many relevant real life examples from the pharmaceutical industry and academia based on their first-hand experience. Along with relevant references, the book highlights current regulatory views. The book covers all aspects of cancer clinical trial starting from early phase development. The early part of the book covers novel phase I dose escalation design, exposure response analysis, and innovative phase II design. This includes early development strategy for cancer immunotherapy trials. The contributors also emphasized the role of biomarker and modern era of precision medicine. The second part focuses on the late stage development. This includes the application of adaptive design, safety analysis, and quality of life (QoL) data analysis. The final part discusses current regulatory perspective and challenges. Features: Covers a wide spectrum of topics related to real-life statistical challenges in oncology clinical trials. Provides a comprehensive overview of novel statistical methods to improve trial design and statistical analysis. Detailed case studies illustrate the real life applications. Satrajit Roychoudhury is a Senior Director and a member of the Statistical Research and Innovation group in Pfizer Inc. Prior to joining; he was a member of Statistical Methodology and consulting group in Novartis. He has 11 years of extensive experience in working with different phases of clinical trial. His area of research includes early phase oncology trials, survival analysis, model informed drug development, and use of Bayesian methods in clinical trials. He is industry co-chair for the ASA Biopharmaceutical Section Regulatory-Industry Workshop and has provided statistical training in major conferences including the Joint Statistical Meetings, ASA Biopharmaceutical Section Regulatory-Industry Workshop, and ICSA Applied Statistics Symposium. Soumi Lahiri has 12 years of extensive experience in working different therapeutic areas. She is the former Director of Biostatistics in Clinical Oncology, GlaxoSmithKline. She has also worked in the oncology division of Novartis Pharmaceutical Company for two years. She is an active member of the ASA Biopharmaceutical section and former chair of the membership committee.
Book Synopsis Neoadjuvant Immunotherapy Treatment of Localized Genitourinary Cancers by : Andrea Necchi
Download or read book Neoadjuvant Immunotherapy Treatment of Localized Genitourinary Cancers written by Andrea Necchi and published by Springer Nature. This book was released on 2022-01-03 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book aims to provide readers with a current overview of enrolling trials with immune-checkpoint inhibitors in the preoperative setting of localized bladder cancer, renal cell carcinoma, and prostate cancer. The advent of immunotherapy has revolutionized treatments of genitourinary malignancy and evolved strategies for multidisciplinary management. This book explains neoadjuvant checkpoint inhibitors in localized genitourinary cancers, providing insights into the mechanisms of response and development of resistance of cancer cells to immunotherapy. It debates optimal trial design of preoperative checkpoint inhibitors in GU tumors, including optimal endpoints and the role of pathologic response as a surrogate endpoint of survival. It also illuminates clinical management of patients with organ-confined GU tumors, such as side effect management and perioperative safety, before providing an overview of biomarker use for patient selection across the early-stage GU malignancies. Lastly, the book provides the reader with the most up-to-date data emerging from clinical trials involving immunotherapy in early-stage GU malignancies. Neoadjuvant Immunotherapy Treatment of Localized Genitourinary Cancers: Multidisciplinary Management provides a comprehensive review of the field, serving as a valuable resource for urologists, medical oncologists, pathologists, fellows in urologic oncology, upper-level residents training in urology and medical oncology, as well as pharmacists interested in RCC clinicians.
Book Synopsis Non-surgical Ablation Therapy for Early-stage Breast Cancer by : Takayuki Kinoshita
Download or read book Non-surgical Ablation Therapy for Early-stage Breast Cancer written by Takayuki Kinoshita and published by Springer. This book was released on 2016-06-21 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering the history of breast cancer, theory of radiofrequency ablation (RFA), resection of carcinoma, imaging before and after non-surgical ablation therapy and quality of life, this book focuses on extensive breast-conserving treatment for the preservation of a cosmetically acceptable breast. It investigates the feasibility of percutaneous, minimally invasive techniques to ablate breast tumors and several modalities such as cryosurgery, laser ablation, thermoablation and high-intensity focused ultrasound. Non-surgical Ablation Therapy for Early-stage Breast Cancer centers on RFA and provides insights into cryoablation and focused ultrasound surgery. RFA has been shown to be effective for treating tumors in many types of tissue, including liver, bone, brain, kidney, pancreas and prostate. As such this book is a valuable resource for breast and general surgeons, radiation oncologists and medical oncologists in all areas. The extensive discussions enable scholars to gain radiological expertise and a basic understanding of molecular biology, leading to better surgery without scalpels.
Book Synopsis Management of Early Stage Breast Cancer by : Beena Kunheri
Download or read book Management of Early Stage Breast Cancer written by Beena Kunheri and published by Springer Nature. This book was released on 2020-10-01 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: Breast cancer, its causes, early detection and treatment have received considerable attention, since this widespread disease is one of the most important health concerns for women. This book provides a comprehensive overview of the diagnostic and therapeutic aspects of the management of early-stage breast cancer, including essential information on basic topics like pathology, and radiology, as well as the latest developments. Further, it discusses all aspects of surgical care, chemotherapy and radiation therapy, together with the controversies and current management guidelines. Helping readers acquire a deep, holistic understanding of the topic, the book is a valuable resource for practitioners and postgraduate students in the field of gynecologic oncology. Moreover, it is a useful aid to decision-making in day-to-day practice for oncologists, residents, fellows and experienced practitioners.
Book Synopsis Dose-Finding Designs for Early-Phase Cancer Clinical Trials by : Takashi Daimon
Download or read book Dose-Finding Designs for Early-Phase Cancer Clinical Trials written by Takashi Daimon and published by Springer. This book was released on 2019-05-21 with total page 133 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive introduction to statistical methods for designing early phase dose-finding clinical trials. It will serve as a textbook or handbook for graduate students and practitioners in biostatistics and clinical investigators who are involved in designing, conducting, monitoring, and analyzing dose-finding trials. The book will also provide an overview of advanced topics and discussions in this field for the benefit of researchers in biostatistics and statistical science. Beginning with backgrounds and fundamental notions on dose finding in early phase clinical trials, the book then provides traditional and recent dose-finding designs of phase I trials for, e.g., cytotoxic agents in oncology, to evaluate toxicity outcome. Included are rule-based and model-based designs, such as 3 + 3 designs, accelerated titration designs, toxicity probability interval designs, continual reassessment method and related designs, and escalation overdose control designs. This book also covers more complex and updated dose-finding designs of phase I-II and I/II trials for cytotoxic agents, and cytostatic agents, focusing on both toxicity and efficacy outcomes, such as designs with covariates and drug combinations, maximum tolerated dose-schedule finding designs, and so on.
Book Synopsis Cancer Incidence and Survival Among Children and Adolescents by :
Download or read book Cancer Incidence and Survival Among Children and Adolescents written by and published by . This book was released on 1999 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt:
