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Author : P. Scully
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (938 download)
Download or read book Imaging Biomarkers of Treatment Response: Applications to Clinical Trials written by P. Scully and published by . This book was released on 2015 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 294 pages
Book Rating : 4.:/5 (934 download)
Download or read book Imaging Biomarkers of Treatment Response written by and published by . This book was released on 2015 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quantitative imaging biomarkers -- numerical measurements derived from medical imaging that can be interpreted by clinicians - are a critical component of treatment response assessment in oncology. They can also play an important role in the design and interpretation of clinical trials, provided that they are measured following a standardized set of best practices. In this thesis, we have demonstrated the successful application of imaging biomarkers of treatment response to a clinical trial assessing the pharmacodynamics and pharmacokinetics of the anti-angiogenic TKI therapeutic Axitinib. We have illustrated the challenges facing quantitative imaging biomarkers in general, and gained valuable insights into anti-angiogenic therapy in particular. We have characterized the pharmacodynamics of "withdrawal flare," a rapid increase in tumor proliferation following cessation of anti-angiogenic therapy, using quantitative imaging biomarkers derived from FLT PET. This is the first time in humans that the temporal dynamics of Axitinib withdrawal flare have been characterized, a critical step in optimizing the use of this drug in combination therapy. Although we demonstrated that significant flare occurs in patients treated with Axitinib, we also observed substantial inter-patient heterogeneity in imaging response during withdrawal. Among the sub-set of patients experiencing withdrawal flare, it was found to occur at two days post-cessation of Axitinib, with relatively little additional flare between days 2 and 7 of withdrawal. Moreover, withdrawal flare was found to be associated with poor clinical outcome. We directly compared the results of the Axitinib trial with an earlier trial of a related anti-angiogenic drug, Sunitinib, which had used the same imaging biomarkers of treatment response. The proliferative and vascular response during withdrawal of Axitinib and Sunitinib was found to be nearly identical, and there is not sufficient evidence to support any significant difference in proliferative response during treatment. We also explored intra-patient, inter-lesion response heterogeneity. However, when comparing the imaging response with pre-treatment phenotypes, no significant correlations were observed, suggesting that some underlying biological mechanisms may be driving the inter-lesion differences in response. The insights gained from this original work support several hypotheses for how to improve patient treatment. These hypotheses will be partially addressed in three new ongoing clinical trials at the University of Wisconsin.
Author : Luis Martí-Bonmatí
Publisher : Springer
ISBN 13 : 3319435043
Total Pages : 313 pages
Book Rating : 4.3/5 (194 download)
Download or read book Imaging Biomarkers written by Luis Martí-Bonmatí and published by Springer. This book was released on 2016-11-03 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first book to cover all aspects of the development of imaging biomarkers and their integration into clinical practice, from the conceptual basis through to the technical aspects that need to be considered in order to ensure that medical imaging can serve as a powerful quantification instrument capable of providing valuable information on organ and tissue properties. The process of imaging biomarker development is considered step by step, covering proof of concept, proof of mechanism, image acquisition, image preparation, imaging biomarker analysis and measurement, detection of measurement biases (proof of principle), proof of efficacy and effectiveness, and reporting of results. Sources of uncertainty in the accuracy and precision of measurements and pearls and pitfalls in gold standards and biological correlation are discussed. In addition, practical use cases are included on imaging biomarker implementation in brain, oncologic, cardiovascular, musculoskeletal, and abdominal diseases. The authors are a multidisciplinary team of expert radiologists and engineers, and the book will be of value to all with an interest in the quantitative imaging of biomarkers in personalized medicine.
Author : John Bloom
Publisher : CRC Press
ISBN 13 : 0824755197
Total Pages : 312 pages
Book Rating : 4.8/5 (247 download)
Download or read book Biomarkers in Clinical Drug Development written by John Bloom and published by CRC Press. This book was released on 2003-05-20 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presenting applications in clinical development, pharmacokinetic/ pharmacodynamic modelling and clinical trial simulation, this reference studies the role of biomarkers in successful drug formulation and development.
Author : Michael R. Bleavins
Publisher : John Wiley & Sons
ISBN 13 : 1118210425
Total Pages : 559 pages
Book Rating : 4.1/5 (182 download)
Download or read book Biomarkers in Drug Development written by Michael R. Bleavins and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 559 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eight parts: Part One offers an overview of biomarkers and their role in drug development. Part Two highlights important technologies to help researchers identify new biomarkers. Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose. Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309224187
Total Pages : 354 pages
Book Rating : 4.3/5 (92 download)
Download or read book Evolution of Translational Omics written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-13 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309157277
Total Pages : 335 pages
Book Rating : 4.3/5 (91 download)
Download or read book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease written by Institute of Medicine and published by National Academies Press. This book was released on 2010-06-25 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.
Author : Christie Lin
Publisher :
ISBN 13 :
Total Pages : 158 pages
Book Rating : 4.:/5 (18 download)
Download or read book Establishing 18F-NaF PET Quantitative Imaging Biomarkers for Treatment Response Assessment written by Christie Lin and published by . This book was released on 2018 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of functional imaging with positron emission tomography (PET) has increased in clinical oncology to assess response to therapy. Response assessment with PET scans is largely interpreted qualitatively, which results in subjective clinical evaluation. Alternatively, quantitative imaging can enable objective evaluation; however, the path to establish standardized response criteria of candidate quantitative imaging biomarkers (QIBs) is extremely challenging. This dissertation focused on establishing quantitative 18F-NaF PET-based treatment response assessment. Using 18F-NaF PET/CT scans of bone tumors (osseous lesions) in metastatic castration-resistant prostate cancer patients imaged in a multi-center clinical trial, we characterized test-retest repeatability of standardized uptake values (SUVs) measured from both lesions and patients, and reproducibility across imaging sites. From these studies we derived the limits of agreement, which can be interpreted as objective response criteria. To assess the generalizability of response criteria, we investigated sources of variability that may influence response assessment. Linear mixed effects models identified both differences in injected dose between scans and anatomical location of the lesion may influence repeatability. To address the need to mitigate potential variability in longitudinal imaging, we evaluated the utility of reference region normalization but found that SUVs were similarly robust without. In order to advance criteria for QIBs of response, we introduced the response-to-repeatability metric and discovered that not all candidate QIBs were able to discern statistically measurable changes at treatment follow-up. In our last study, we introduced a bootstrapping method to estimate sample size requirements needed to achieve a desired level of repeatability, a critical component in clinical trial design. Finally, we outlined statistical limitations to the generalizability of response criteria, which will guide appropriate implementation of imaging-based response assessment in the clinical routine. In summary, we present a statistical basis to enable quantitative imaging-based response criteria and methods to iteratively advance needs in both research and the clinic.
Author : Ramin Rahbari
Publisher : John Wiley & Sons
ISBN 13 : 1119187524
Total Pages : 624 pages
Book Rating : 4.1/5 (191 download)
Download or read book Biomarkers in Drug Discovery and Development written by Ramin Rahbari and published by John Wiley & Sons. This book was released on 2020-02-28 with total page 624 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book continues the legacy of a well-established reference within the pharmaceutical industry – providing perspective, covering recent developments in technologies that have enabled the expanded use of biomarkers, and discussing biomarker characterization and validation and applications throughout drug discovery and development. Explains where proper use of biomarkers can substantively impact drug development timelines and costs, enable selection of better compounds and reduce late stage attrition, and facilitate personalized medicine Helps readers get a better understanding of biomarkers and how to use them, for example which are accepted by regulators and which still non-validated and exploratory Updates developments in genomic sequencing, and application of large data sets into pre-clinical and clinical testing; and adds new material on data mining, economics, and decision making, personal genetic tools, and wearable monitoring Includes case studies of biomarkers that have helped and hindered decision making Reviews of the first edition: "If you are interested in biomarkers, and it is difficult to imagine anyone reading this who wouldn't be, then this book is for you." (ISSX) and "...provides a good introduction for those new to the area, and yet it can also serve as a detailed reference manual for those practically involved in biomarker implementation." (ChemMedChem)
Author : Sunil Badve
Publisher : Springer
ISBN 13 : 3319952285
Total Pages : 642 pages
Book Rating : 4.3/5 (199 download)
Download or read book Predictive Biomarkers in Oncology written by Sunil Badve and published by Springer. This book was released on 2018-12-06 with total page 642 pages. Available in PDF, EPUB and Kindle. Book excerpt: “Precision/personalized or stratified medicine” refers to the tailoring of medical treatment or drug administration to the individual characteristics of each patient treatment. It does not literally mean that a pharmaceutical company makes a drug for an individual patient for consumption and treatment but rather means the ability to stratify (or classify) individuals into sub-populations that differ in their responsiveness to a specific drug. A marker that provides information on the likely response to therapy, i.e., either in terms of tumor shrinkage or survival of the patient is termed “predictive biomarker”. Despite their promise in precision medicine and the explosion of knowledge in this area, there is not a single source on this subject that puts all this evidence together in a concise or richly illustrated and easy to understand manner. This book provides a collection of ingeniously organized, well-illustrated and up-to-date authoritative chapters divided into five sections that are clear and easy to understand. Section one provides an overview of biomarkers, introduces the basic terminologies, definitions, technologies, tools and concepts associated with this subject in the form of illustrations/graphics, photographs and concise texts. Several recent biomarker endeavors that have been initiated and funded by the National Cancer Institute, National Institutes of Health, FDA and other International organizations are presented. Section two involves the signaling pathways controlling cell growth and differentiation altered in cancer. This section analyzes how predictive biomarkers are altered (expressed or amplified) across cancer types. Section three explores how predictive biomarkers play a role in patient stratification and tailored treatment in relationship to specific cancers. In addition, it includes discussion on the various precision medicine initiatives that are going on across the globe (e.g. TARGET, NCI-MATCH, BATTLE, SHIVA, etc.). Section four discusses: (a) how pharmaceutical companies validate predictive biomarker assays and accompanying companion diagnostics either internally or externally with partner companies such as central laboratories or clinical research organizations, and (b) how predictive biomarker tests fall under the oversight of US FDA, Centers for Medicare & Medicaid Services (CMS) and state laws. Section five wraps up novel agents and targets that are being used as targets for cancer therapeutics. The biomarkers associated with these protocols will also be presented. Throughout the book, sidebars, special interest boxes and illustrations are used to explain terms that are either newly introduced, uncommon, or specialized. Predictive Biomarkers in Oncology will serve as a definitive guide for practicing pathologists, oncologists, basic researchers, and personnel in the pharmaceutical or diagnostic industry interested in learning how “predictive biomarkers” are used in precision cancer therapy.
Author : Claudio Carini
Publisher : CRC Press
ISBN 13 : 0429576730
Total Pages : 631 pages
Book Rating : 4.4/5 (295 download)
Download or read book Handbook of Biomarkers and Precision Medicine written by Claudio Carini and published by CRC Press. This book was released on 2019-04-16 with total page 631 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The field of Biomarkers and Precision Medicine in drug development is rapidly evolving and this book presents a snapshot of exciting new approaches. By presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge and find examples that will help them in their own work." -Maria Freire, Foundation for the National Institutes of Health Handbook of Biomarkers and Precision Medicine provides comprehensive insights into biomarker discovery and development which has driven the new era of Precision Medicine. A wide variety of renowned experts from government, academia, teaching hospitals, biotechnology and pharmaceutical companies share best practices, examples and exciting new developments. The handbook aims to provide in-depth knowledge to research scientists, students and decision makers engaged in Biomarker and Precision Medicine-centric drug development. Features: Detailed insights into biomarker discovery, validation and diagnostic development with implementation strategies Lessons-learned from successful Precision Medicine case studies A variety of exciting and emerging biomarker technologies The next frontiers and future challenges of biomarkers in Precision Medicine Claudio Carini, Mark Fidock and Alain van Gool are internationally recognized as scientific leaders in Biomarkers and Precision Medicine. They have worked for decades in academia and pharmaceutical industry in EU, USA and Asia. Currently, Dr. Carini is Honorary Faculty at Kings’s College School of Medicine, London, UK. Dr. Fidock is Vice President of Precision Medicine Laboratories at AstraZeneca, Cambridge, UK. Prof.dr. van Gool is Head Translational Metabolic Laboratory at Radboud university medical school, Nijmegen, NL.
Author : Elke Hattingen
Publisher : Springer
ISBN 13 : 3642450407
Total Pages : 166 pages
Book Rating : 4.6/5 (424 download)
Download or read book Brain Tumor Imaging written by Elke Hattingen and published by Springer. This book was released on 2015-09-02 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the basics, the challenges and the limitations of state of the art brain tumor imaging and examines in detail its impact on diagnosis and treatment monitoring. It opens with an introduction to the clinically relevant physical principles of brain imaging. Since MR methodology plays a crucial role in brain imaging, the fundamental aspects of MR spectroscopy, MR perfusion and diffusion-weighted MR methods are described, focusing on the specific demands of brain tumor imaging. The potential and the limits of new imaging methodology are carefully addressed and compared to conventional MR imaging. In the main part of the book, the most important imaging criteria for the differential diagnosis of solid and necrotic brain tumors are delineated and illustrated in examples. A closing section is devoted to the use of MR methods for the monitoring of brain tumor therapy. The book is intended for radiologists, neurologists, neurosurgeons, oncologists and other scientists in the biomedical field with an interest in neuro-oncology.
Author : Christie Lin
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (11 download)
Download or read book Establishing 18F-NaF PET Quantitative Imaging Biomarkers for Treatment Response Assessment written by Christie Lin and published by . This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of functional imaging with positron emission tomography (PET) has increased in clinical oncology to assess response to therapy. Response assessment with PET scans is largely interpreted qualitatively, which results in subjective clinical evaluation. Alternatively, quantitative imaging can enable objective evaluation; however, the path to establish standardized response criteria of candidate quantitative imaging biomarkers (QIBs) is extremely challenging. This dissertation focused on establishing quantitative 18F-NaF PET-based treatment response assessment. Using 18F-NaF PET/CT scans of bone tumors (osseous lesions) in metastatic castration-resistant prostate cancer patients imaged in a multi-center clinical trial, we characterized test-retest repeatability of standardized uptake values (SUVs) measured from both lesions and patients, and reproducibility across imaging sites. From these studies we derived the limits of agreement, which can be interpreted as objective response criteria. To assess the generalizability of response criteria, we investigated sources of variability that may influence response assessment. Linear mixed effects models identified both differences in injected dose between scans and anatomical location of the lesion may influence repeatability. To address the need to mitigate potential variability in longitudinal imaging, we evaluated the utility of reference region normalization but found that SUVs were similarly robust without. In order to advance criteria for QIBs of response, we introduced the response-to-repeatability metric and discovered that not all candidate QIBs were able to discern statistically measurable changes at treatment follow-up. In our last study, we introduced a bootstrapping method to estimate sample size requirements needed to achieve a desired level of repeatability, a critical component in clinical trial design. Finally, we outlined statistical limitations to the generalizability of response criteria, which will guide appropriate implementation of imaging-based response assessment in the clinical routine. In summary, we present a statistical basis to enable quantitative imaging-based response criteria and methods to iteratively advance needs in both research and the clinic.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309178282
Total Pages : 128 pages
Book Rating : 4.3/5 (91 download)
Download or read book Neuroscience Biomarkers and Biosignatures written by Institute of Medicine and published by National Academies Press. This book was released on 2008-01-08 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomarkers, or biological markers, are quantitative measurements that offer researchers and clinicians valuable insight into diagnosis, treatment and prognosis for many disorders and diseases. A major goal in neuroscience medical research is establishing biomarkers for disorders of the nervous system. Given the promising potential and necessity for neuroscience biomarkers, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened a public workshop and released the workshop summary entitled Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships. The workshop brought together experts from multiple areas to discuss the most promising and practical arenas in neuroscience in which biomarkers will have the greatest impact. The main objective of the workshop was to identify and discuss biomarker targets that are not currently being aggressively pursued but that could have the greatest near-term impact on the rate at which new treatments are brought forward for psychiatric and neurological disorders.
Author : Christopher Jennison
Publisher : CRC Press
ISBN 13 : 9781584888581
Total Pages : 416 pages
Book Rating : 4.8/5 (885 download)
Download or read book Group Sequential Methods with Applications to Clinical Trials written by Christopher Jennison and published by CRC Press. This book was released on 1999-09-15 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: Group sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early dissemination of its findings. Group sequential methods provide a means to balance the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion. Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test and interim analysis schedule. Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models. Research in group sequential analysis has progressed rapidly over the past 20 years. Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. Medical statisticians engaged in any investigations planned with interim analyses will find this book a useful and important tool.
Author : James L. Mulshine
Publisher : Wiley-OSA
ISBN 13 :
Total Pages : 184 pages
Book Rating : 4.3/5 (91 download)
Download or read book Quantitative Imaging Tools for Lung Cancer Drug Assessment written by James L. Mulshine and published by Wiley-OSA. This book was released on 2008-04-14 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presents chapters written by leading clinical researchers in the field of lung cancer, where high resolution 3-D imaging technology appears to hold the greatest near-term promise, as well as contributions from recognized experts in CAD, medical information technology systems, regulatory procedure, x-ray standards development, and clinical trial design. These expert contributors discuss the current state of the art and provide a road map for directing further research in lung cancer as well as other organ systems.
Author : Sibel A. Ozkan
Publisher : Academic Press
ISBN 13 : 0128230754
Total Pages : 615 pages
Book Rating : 4.1/5 (282 download)
Download or read book The Detection of Biomarkers written by Sibel A. Ozkan and published by Academic Press. This book was released on 2021-12-05 with total page 615 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reliable, precise and accurate detection and analysis of biomarkers remains a significant challenge for clinical researchers. Methods for the detection of biomarkers are rather complex, requiring pre-treatment steps before analysis can take place. Moreover, comparing various biomarker assays and tracing research progress in this area systematically is a challenge for researchers. The Detection of Biomarkers presents developments in biomarker detection, including methods tools and strategies, biosensor design, materials, and applications. The book presents methods, materials and procedures that are simple, precise, sensitive, selective, fast and economical, and therefore highly practical for use in clinical research scenarios. This volume situates biomarker detection in its research context and sets out future prospects for the area. Its 20 chapters offer a comprehensive coverage of biomarkers, including progress on nanotechnology, biosensor types, synthesis, immobilization, and applications in various fields. The book also demonstrates, for students, how to synthesize and immobilize biosensors for biomarker assay. It offers researchers real alternative and innovative ways to think about the field of biomarker detection, increasing the reliability, precision and accuracy of biomarker detection. Locates biomarker detection in its research context, setting out present and future prospects Allows clinical researchers to compare various biomarker assays systematically Presents new methods, materials and procedures that are simple, precise, sensitive, selective, fast and economical Gives innovative biomarker assays that are viable alternatives to current complex methods Helps clinical researchers who need reliable, precise and accurate biomarker detection methods
