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Alzheimer`s & Dementia

Year: 2011  |  Volume: 7  |  Issue: 2  |  Page No.: 197 - 207

Global issues in drug development for Alzheimer‘s disease

Rachelle S. Doody, Patricia E. Cole, David S. Miller, Eric Siemers, Ronald Black, Howard Feldman, Rachel Schindler, Stephen Graham, Theresa Heath, Ara S. Khachaturian, Rebecca Evans and Maria C. Carrillo

Abstract

The number of clinical trials for Alzheimer‘s disease conducted outside the United States in a broad array of countries is increasing. As the number of compounds ready for clinical testing increases, and as trials become longer and more complex, this trend is expected to grow. The cultural and ethical context of global clinical trials, potential benefits for those involved, and practical approaches to obstacles generated by these global trials were discussed at a meeting of the Alzheimer‘s Association Research Roundtable. Regulatory issues, including regional differences in study registration procedures, rules for collecting and reporting serious adverse events, requirements for national identity of study populations, and regulatory audits were also discussed by individuals who are knowledgeable about global clinical trials for Alzheimer‘s disease.

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