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Clinical trials --- Clinical trials --- Clinical Trials as Topic. --- Information services.
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Clinical trials --- Clinical Trials as Topic. --- Therapies, Investigational. --- Medical Research
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Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.--Publishers website
Drugs --- Testing. --- Clinical Trials as Topic --- Virtual Reality --- methods --- United States
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Quality Improvement --- Quality Assurance, Health Care --- Human Experimentation --- Clinical Trials as Topic --- standards --- methods --- Études cliniques. --- Expérimentation humaine en médecine --- Assurance qualité --- Assurance de la qualité des soins de santé --- Clinical Trials as Topic.
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Pathology --- Diagnosis, Laboratory --- Medicine --- Clinical Trials as Topic. --- Pathology. --- Clinical Laboratory Techniques. --- clinical research. --- Pathologie --- Diagnostics biologiques
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Alzheimer’s disease (AD) is a chronic neurodegenerative disorder characterized by progressive cognitive dysfunction and memory loss, inability to perform the activities of daily living and mood disorders. According to the so-called “amyloid cascade hypothesis”, amyloid-ß- peptide (Aß), produced by beta- and gamma- secretase-mediated cleavages of the amyloid precursor protein (APP), plays a pivotal role in the pathogenesis of AD. Aß was also shown to contribute to AD pathology by stimulating the hyperphosphorylation of tau which is responsible for the formation of neurofibrillary tangles. However, the “amyloid cascade hypothesis” was challenged by other theories which lend support to the idea that Aß is not causative but can be considered as an “innocent bystander” in AD. Although preclinical research generated impressive lines of evidence about the several intracellular mechanism(s) whose impairment leads to the onset and progression of AD, clinical research aimed at the development of new drugs capable of preventing or delaying the onset of neuronal damage in AD patients has produced limited results. The drugs currently available for the treatment of AD are acetylcholinesterase inhibitors (AChEI) and the NMDA glutamate receptor antagonist memantine. The AChEI increase acetylcholine levels in the synaptic cleft, which are reduced because of the progressive damage of cholinergic neurons in cognitive brain areas (e.g. amygdala, hippocampus, and frontal cortex), whereas memantine is used to prevent/reduce calcium-dependent excitotoxic neuronal cell death. Both classes of drugs have been shown to improve symptoms related to cognitive decline, but their effects are confined largely to patients with mild to moderate AD, in particular during the first year or so of treatment. An alternative to this symptomatic treatments involves the use of drugs that intervene in the pathogenesis of the disease. Recently, monoclonal antibodies against Aß were proposed as novel agents capable to remove Aß from the brain thus preventing neuronal damage. The research topic focuses on the preclinical and clinical evidence about the several factors that contribute to the pathogenesis of AD as well as the potential therapeutic role of new classes of drugs still under preclinical or clinical development.
Alzheimer's disease. --- preclinical studies --- neurodegeneration --- Clinical Trials as Topic --- drug research and development --- Alzheimer's disease
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Drugs --- Pharmacy --- Clinical Trials as Topic. --- Drug Evaluation. --- Drug Industry. --- Pharmacology, Clinical. --- Testing --- Research --- Clinical Trials. --- Testing. --- Research. --- Clinical Trials --- Drug Evaluation --- Drug Industry --- Pharmacology, Clinical
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Clinical Medicine. --- Clinical Trials as Topic. --- Therapies, Investigational. --- Experimental Therapies --- Innovative Therapies --- Investigational Treatments --- Investigational Therapies --- Experimental Therapy --- Innovative Therapy --- Investigational Therapy --- Investigational Treatment --- Therapies, Experimental --- Therapies, Innovative --- Therapy, Experimental --- Therapy, Innovative --- Therapy, Investigational --- Treatment, Investigational --- Treatments, Investigational --- Clinical Trials as Topic --- Clinical Trial as Topic --- Clinical Protocols --- Drug Evaluation --- Drugs, Investigational --- Clinical Trials Data Monitoring Committees --- Therapies, Investigational --- Medicine, Clinical
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Clinical Trials and Tribulations evaluates the multiple layers of complexities around research management, also exploring current practices, challenges and future directions. The book provides answers to readers questions and problems through extensive use of real-world examples, case studies and lessons learned. Following an approach to provide pragmatic viewpoints as well as concepts and methodologies and its alignment with specific practices, the book explores paradigms between planning and conducting research in academia vs. healthcare vs. industry in the UK vs. Europe vs. America. It highlights practical solutions to real-world complex issues that have been documented by independent regulators. This will be an indispensable book for all staff working in clinical research within healthcare, academia and industry, as well as students intending to work in clinical trials. Covers key topics across pre-clinical, clinical research and clinical practice. Highlights areas such as the socioeconomics of conducting research, capacity and capability, research quality and performance (including performance indicators, adaptive design and practical solutions); Provides lessons learned from breach of protocols, ethical breaches, SAE/SUSARs, aseptic pharmacy preparation issues, and instability within research structures ; Includes a focus on the UK clinical research system, offering key insights into working within the UK and collaborating with UK partners.
Clinical trials. --- Controlled clinical trials --- Patient trials of new treatments --- Randomized clinical trials --- Trials, Clinical --- Clinical medicine --- Human experimentation in medicine --- Research --- Clinical Trials as Topic --- Research Design --- Management.
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Clinical trials --- Clinical Trials --- Clinical Trials. --- Medicine. --- Clinical trials. --- Controlled clinical trials --- Patient trials of new treatments --- Randomized clinical trials --- Trials, Clinical --- Medical Specialities --- Medical Specialties --- Medical Specialty --- Specialities, Medical --- Specialties, Medical --- Specialty, Medical --- Medical Speciality --- Speciality, Medical --- Clinical medicine --- Human experimentation in medicine --- Research --- Health Workforce --- Clinical Trials as Topic. --- Clinical Trial as Topic --- Clinical Protocols --- Drug Evaluation --- Drugs, Investigational --- Clinical Trials Data Monitoring Committees --- Therapies, Investigational --- Clinical Trials as Topic
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