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Apr 2016
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Assessing Cognitive Safety of Drugs in Clinical Development

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Overview

Spend 60 minutes with two industry experts and walk away with a firm understanding of why there is a need to assess cognitive safety in clinical development of compounds, the methodological considerations for cognitive assessment in clinical trials, approaches to the analysis and interpretation of cognitive outcome measures and how current state-of-the-art cognitive assessment technology can be incorporated into the clinical development process to facilitate early decision making, evaluate cognitive efficacy, profile safety and tolerability and satisfy regulatory requirements in an increasingly challenging and competitive pharmaceutical landscape.

Importance for Drug Development: The presenters will discuss why the accurate measurement of specific aspects of cognitive function is essential for the evaluation of the efficacy of new medications being developed to treat some of our most feared and devastating medical conditions such as Alzheimer’s disease, depression, schizophrenia and ADHD. Recognizing that the ability to test, measure and monitor cognitive performance over time introduces the opportunity for patients to be identified earlier and more accurately, the evaluation of new treatments faster and more efficiently, and to improve decision making throughout the development process.

Value Across the Drug Development Cycle for All Therapies: Any drug that crosses the blood-brain barrier (BBB) can produce cognitive effects that can interfere with everyday functioning. Importantly, this includes drugs for both CNS and non-CNS indications (e.g. cardiovascular drugs; including statins, diabetes, oncology, HIV, pain, antihistamines, anticonvulsants and antimuscarinics). The presenters will explore strategies for measuring cognitive function during clinical drug development for all therapies and how this can help determine dose-response relationships, provide competitive differentiation, detect off-target pharmacological effects and assess the risk/benefit profiles.

Review of Methodologies, Study Design and Analysis: Learn how when assessing cognitive safety in a clinical trial, one also has to be aware of basic methodological principles, including study design and statistical analysis, from Phase I through to postmarketing as well as how best to interpret the magnitude of any identified effects, including comparison with benchmarks.

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