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Evolution of Translational Omics
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.
An Evidence Framework for Genetic Testing
Advances in genetics and genomics are transforming medical practice, resulting in a dramatic growth of genetic testing in the health care system. The rapid development of new technologies, however, has also brought challenges, including the need for rigorous evaluation of the validity and utility of genetic tests, questions regarding the best ways to incorporate them into medical practice, and how to weigh their cost against potential short- and long-term benefits. As the availability of genetic tests increases so do concerns about the achievement of meaningful improvements in clinical outcomes, costs of testing, and the potential for accentuating medical care inequality. Given the rapid pace in the development of genetic tests and new testing technologies, An Evidence Framework for Genetic Testing seeks to advance the development of an adequate evidence base for genetic tests to improve patient care and treatment. Additionally, this report recommends a framework for decision-making regarding the use of genetic tests in clinical care.
Fostering Integrity in Research
The integrity of knowledge that emerges from research is based on individual and collective adherence to core values of objectivity, honesty, openness, fairness, accountability, and stewardship. Integrity in science means that the organizations in which research is conducted encourage those involved to exemplify these values in every step of the research process. Understanding the dynamics that support â€" or distort â€" practices that uphold the integrity of research by all participants ensures that the research enterprise advances knowledge. The 1992 report Responsible Science: Ensuring the Integrity of the Research Process evaluated issues related to scientific responsibility and th...
Sharing Clinical Trial Data
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsi...
Generating Evidence for Genomic Diagnostic Test Development
Ten years after the sequencing of the human genome, scientists have developed genetic tests that can predict a person's response to certain drugs, estimate the risk of developing Alzheimer's disease, and make other predictions based on known links between genes and diseases. However, genetic tests have yet to become a routine part of medical care, in part because there is not enough evidence to show they help improve patients' health. The Institute of Medicine (IOM) held a workshop to explore how researchers can gather better evidence more efficiently on the clinical utility of genetic tests. Generating Evidence for Genomic Diagnostic Test Development compares the evidence that is required for decisions regarding clearance, use, and reimbursement, to the evidence that is currently generated. The report also addresses innovative and efficient ways to generate high-quality evidence, as well as barriers to generating this evidence. Generating Evidence for Genomic Diagnostic Test Development contains information that will be of great value to regulators and policymakers, payers, health-care providers, researchers, funders, and evidence-based review groups.
Rare Neurodegenerative Disorders - New Insights
Neurodegenerative diseases share the common property of neuronal loss in the higher-order association and limbic cortices or the extrapyramidal and pyramidal motor systems. In addition, oligodendroglia, astrocytes, and microglia have been implicated in fundamental abnormalities of virtually every neurodegenerative disorder. The particular system affected, more importantly the distribution of the pathology, determines the clinical presentation. While the most common dementia and movement disorders, such as Alzheimer’s disease, Lewy body disease, and frontotemporal lobar degeneration with TDP-43 pathology, including amyotrophic lateral sclerosis, have been extensively studied, many less comm...
The Future of Scientific Knowledge Discovery in Open Networked Environments
Digital technologies and networks are now part of everyday work in the sciences, and have enhanced access to and use of scientific data, information, and literature significantly. They offer the promise of accelerating the discovery and communication of knowledge, both within the scientific community and in the broader society, as scientific data and information are made openly available online. The focus of this project was on computer-mediated or computational scientific knowledge discovery, taken broadly as any research processes enabled by digital computing technologies. Such technologies may include data mining, information retrieval and extraction, artificial intelligence, distributed ...
Biomarkers in Environmental and Human Health Biomonitoring
Biomarkers in Environmental and Human Health Biomonitoring: An Integrated Perspective provides a holistic view of the biomonitoring of environmental degradation, accumulated toxicity, and associated human health concerns. The book incorporates theoretical and practical aspects of the biomonitoring of environmental pollution and the health surveillance of ecological communities using samples from living organisms which are analyzed for contaminants and toxin levels. In the first half, the book provides a general overview if the different types of biomarkers, their significance as bioindicators for contaminants and detection of toxicity, as well as how they can be utilized in the restoration o...
Toward Precision Medicine
Motivated by the explosion of molecular data on humans-particularly data associated with individual patients-and the sense that there are large, as-yet-untapped opportunities to use this data to improve health outcomes, Toward Precision Medicine explores the feasibility and need for "a new taxonomy of human disease based on molecular biology" and develops a potential framework for creating one. The book says that a new data network that integrates emerging research on the molecular makeup of diseases with clinical data on individual patients could drive the development of a more accurate classification of diseases and ultimately enhance diagnosis and treatment. The "new taxonomy" that emerge...
