Criteria for the use of omics-based predictors in clinical trials: explanation and elaboration

Abstract High-throughput ‘omics’ technologies that generate molecular profiles for biospecimens have been extensively used in preclinical studies to reveal molecular subtypes and elucidate the biological mechanisms of disease, and in retrospective studies on clinical specimens to develop mathematical models to predict clinical endpoints. Nevertheless, the translation of these technologies into clinical tests that are useful for guiding management decisions for patients has been relatively slow. It can be difficult to determine when the body of evidence for an omics-based test is sufficiently comprehensive and reliable to support claims that it is ready for clinical use, or even that it is ready for definitive evaluation in a clinical trial in which it may be used to direct patient therapy. Reasons for this difficulty include the exploratory and retrospective nature of many of these studies, the complexity of these assays and their application to clinical specimens, and the many potential pitfalls inherent in the development of mathematical predictor models from the very high-dimensional data generated by these omics technologies. Here we present a checklist of criteria to consider when evaluating the body of evidence supporting the clinical use of a predictor to guide patient therapy. Included are issues pertaining to specimen and assay requirements, the soundness of the process for developing predictor models, expectations regarding clinical study design and conduct, and attention to regulatory, ethical, and legal issues. The proposed checklist should serve as a useful guide to investigators preparing proposals for studies involving the use of omics-based tests. The US National Cancer Institute plans to refer to these guidelines for review of proposals for studies involving omics tests, and it is hoped that other sponsors will adopt the checklist as well.http://deepblue.lib.umich.edu/bitstream/2027.42/134536/1/12916_2013_Article_1104.pd

Evaluating the methodology of social experiments

Welfare ; Econometric models

Psychometrics in Practice at RCEC

A broad range of topics is dealt with in this volume: from combining the psychometric generalizability and item response theories to the ideas for an integrated formative use of data-driven decision making, assessment for learning and diagnostic testing. A number of chapters pay attention to computerized (adaptive) and classification testing. Other chapters treat the quality of testing in a general sense, but for topics like maintaining standards or the testing of writing ability, the quality of testing is dealt with more specifically.\ud All authors are connected to RCEC as researchers. They present one of their current research topics and provide some insight into the focus of RCEC. The selection of the topics and the editing intends that the book should be of special interest to educational researchers, psychometricians and practitioners in educational assessment

Applications and Experiences of Quality Control

The rich palette of topics set out in this book provides a sufficiently broad overview of the developments in the field of quality control. By providing detailed information on various aspects of quality control, this book can serve as a basis for starting interdisciplinary cooperation, which has increasingly become an integral part of scientific and applied research

Glass Ceramics Composites Fabricated from Coal Fly Ash and Waste Glass

Great quantities of coal ash are produced in thermal power plants which present a double problem to the society: economical and environmental. This waste is a result of burning of coal at temperatures between 1100-14500C. Fly ash available as fine powder presents a source of important oxides SiO2, Al2O3, Fe2O3, MgO, Na2O, but also consist of small amount of ecologically hazardous oxides such as Cr2O3, NiO, MnO. The combination of the fly ash with waste glass under controlled sintering procedure gave bulk glass-ceramics composite material. The principle of this procedure is presented as a multi barrier concept (1). Many researches have been conducted the investigations for utilization of fly ash as starting material for various glass–ceramics production (2-4). Using waste glass ecologically hazardous components are fixed at the molecular level in the silicate phase and the fabricated new glass-ceramic composites possess significantly higher mechanical properties. The aim of this investigation was to fabricate dense glass ceramic composites using fly ash and waste glass with the potential for its utilization as building material

Modern Approaches To Quality Control

Rapid advance have been made in the last decade in the quality control procedures and techniques, most of the existing books try to cover specific techniques with all of their details. The aim of this book is to demonstrate quality control processes in a variety of areas, ranging from pharmaceutical and medical fields to construction engineering and data quality. A wide range of techniques and procedures have been covered

Development of a small animal conformal irradiator with dual energy x-ray computed tomography imaging for kilovoltage dosimetry

External beam radiotherapy has become technically sophisticated with image guided radiation therapy (IGRT) and intensity modulated radiation therapy (IMRT). These technologies allow for precise delivery of radiation to geometric targets in cancer patients. However, many questions remain on how to best define targets based on biological information, such as functional imaging, and how to combine radiation with other cancer therapies. To help answer these questions, small animal preclinical studies are needed to generate data to inform clinical trials. However, the precise radiation delivery capabilities of IGRT and IMRT have not been available in the preclinical labs. To enable translational experiments and to address the lack of preclinical radiotherapy technology, a commercial micro-CT was first developed into an image-guided conformal radiotherapy system in this thesis. Computerized asymmetric jaws were constructed, implemented and characterized for the system. A Monte Carlo dose calculation package was successfully configured for the system and verified with film measurements. Respiratory gated imaging and radiotherapy was demonstrated with a phantom and in animals. Secondly, accurate radiation dosimetry reduces uncertainties in preclinical experiments. To achieve accurate dose calculations in the kilovoltage x-ray range where photoelectric effects and Compton scattering dominate, knowledge of material composition and density is needed. Dual energy micro-CT was optimized (including choice of x-ray beam peak voltages, filtrations, and duration) and evaluated for the purpose of characterizing materials. Dual energy CT techniques developed for clinical scanners were adapted and examined for micro-CT. A set of micro-CT phantoms consisting of 11 plastic materials and solutions that spanned a relevant range of compositions was designed and constructed. Initial experiments found beam-hardening image artefacts limited accurate measurements. By switching to a more sensitive detector, x-ray spectra with additional beam filtration were possible and resulted in reduced beam-hardening effects. This improved dual energy micro-CT measurement accuracy of material composition and density. In conclusion, a small animal image-guided conformal radiotherapy system was developed and commissioned for preclinical studies. Dual energy micro-CT was demonstrated as a method to characterize materials to improve kilovoltage dose calculation. This integrated micro-CT based small animal image-guided radiation platform has enabled numerous pre-clinical studies

Computer vision for microscopy diagnosis of malaria

This paper reviews computer vision and image analysis studies aiming at automated diagnosis or screening of malaria infection in microscope images of thin blood film smears. Existing works interpret the diagnosis problem differently or propose partial solutions to the problem. A critique of these works is furnished. In addition, a general pattern recognition framework to perform diagnosis, which includes image acquisition, pre-processing, segmentation, and pattern classification components, is described. The open problems are addressed and a perspective of the future work for realization of automated microscopy diagnosis of malaria is provided

Efficient Decision Support Systems

This series is directed to diverse managerial professionals who are leading the transformation of individual domains by using expert information and domain knowledge to drive decision support systems (DSSs). The series offers a broad range of subjects addressed in specific areas such as health care, business management, banking, agriculture, environmental improvement, natural resource and spatial management, aviation administration, and hybrid applications of information technology aimed to interdisciplinary issues. This book series is composed of three volumes: Volume 1 consists of general concepts and methodology of DSSs; Volume 2 consists of applications of DSSs in the biomedical domain; Volume 3 consists of hybrid applications of DSSs in multidisciplinary domains. The book is shaped decision support strategies in the new infrastructure that assists the readers in full use of the creative technology to manipulate input data and to transform information into useful decisions for decision makers