title: Global issues in drug development for Alzheimer's disease.
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.
authors.affiliation: Baylor College of Medicine, Houston, TX, USA. rdoody@bcm.edu
authors.forename: Rachelle S
authors.initials: RS
authors.lastname: Doody
authors.forename: Patricia E
authors.initials: PE
authors.lastname: Cole
authors.forename: David S
authors.initials: DS
authors.lastname: Miller
authors.forename: Eric
authors.initials: E
authors.lastname: Siemers
authors.forename: Ronald
authors.initials: R
authors.lastname: Black
authors.forename: Howard
authors.initials: H
authors.lastname: Feldman
authors.forename: Rachel
authors.initials: R
authors.lastname: Schindler
authors.forename: Stephen
authors.initials: S
authors.lastname: Graham
authors.forename: Theresa
authors.initials: T
authors.lastname: Heath
authors.forename: Ara S
authors.initials: AS
authors.lastname: Khachaturian
authors.forename: Rebecca
authors.initials: R
authors.lastname: Evans
authors.forename: Maria C
authors.initials: MC
authors.lastname: Carrillo
mesh_terms: D000544:Alzheimer Disease / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D003226:Congresses as Topic; D055808:Drug Discovery; D006801:Humans