Globalization of Alzheimer's disease clinical trials: Current characteristics and future goals.

Abstract

There are 182 active trials and 138 unique drugs in the current Alzheimer's disease drug development pipeline. Of these, 33 % of trials are global involving both North American and non-North American sites. Phase 3 clinical trials are more likely to have a global distribution of sites (73 %) than Phase 1 or Phase 2 trials. Considering all global trials together, 32,284 participants are needed to populate the ongoing trials; 25,628 of these are required for Phase 3 trials. From a world region perspective, 100 % of global trials include North America, 45 % involve South America or Mexico, 71 % include Europe Western Europe or Israel, 39 % include Eastern Europe or Russia, 30 % include Asia (not including Japan), 39 % include Japan, and 43 % include South Africa, Australia, or New Zealand. A total of 46 countries are participating in current global trials. Of the 46 countries, 28 % are classified as low-and-middle-income countries. There are 5361 trial sites in active global trials; of these, 50 % are in the United States and 50 % are in other global regions. Seven percent of sites are in low-and-middle income countries. Eighty-nine percent of global trials are sponsored and funded by biopharmaceutical companies. Together these observations suggest that many global regions are involved in Alzheimer's disease clinical trials. North America has a larger number of trials and trials sites than other global regions. Low- and middle-income countries are poorly represented in terms of clinical trial sites. These regions have many patients with Alzheimer's disease and are well suited to advance trial recruitment if adequate infrastructure can be developed.