Titlebook: Clinical Trials in Neurology; Roberto J. Guiloff (Consultant Neurologist) Book 2001 Springer-Verlag London 2001 Ethical Issues.Parkinson.c

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Statistical Issues in Clinical Trials in Neurologytatus and developing trends. This is all that will be attempted in this chapter. More extensive coverage of various statistical issues affecting drug development will be found in Senn [6]. The European Statistical Guideline [7] and International Conference on Harmonisation E9 Guideline are also extr

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Analysis of Results: Statistical Principlesability of a statistic at least as large as that found in the trial . (null hypothesis). If the . value falls below a given threshold of improbability (.-level) under the assumption of no treatment effect, we are led to conclude that the lack of a treatment effect is implausible. For example, the fi

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Dementia: Trial Design and Experience with Large Multicentre Trialsically, yet in life the diagnosis can usually only be made clinically. Moreover, the considerable heterogeneity and broad spectrum of impairment that occurs is difficult to measure in a reliable way. From the earliest clinical trials in AD, drug regulatory authorities, and particularly the US Food a

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Cerebrovascular Disease: Basic Designs, Sample Sizes and Pitfallsthrombolytic therapy [12] in cerebral infarction. There are trials in progress of many other potentially promising treatments such as angioplasty for symptomatic carotid stenosis [13] and neuroprotective treatments for acute ischaemic stroke [3].

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Book 2001with the ethical aspects, drug development and regulatory requirements, basic trial designs and the statistics used. A diseases section tackles specific aspects of disorders, focusing on the relevant ethical issues, outcome variables and experience with large multicentre trials.

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icacy of neurological trials by improving trial design.Clinical Trials in Neurology. comprehensively tackles the methodology and design of clinical trials in neurological disease. A general section deals with the ethical aspects, drug development and regulatory requirements, basic trial designs and

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Omar O. Elrawy,Tamer S. Hamza,Samir S. Hosnyand unobservable variables such as disability, mood and health-related quality of life. In this chapter we begin by defining measurement and outlining the advantages of using standardised measurement methods. Then, we explain why it is important to measure variables such as disability and how they can be measured rigorously using Likert scales.

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