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Global Clinical Trials for Alzheimer’s Disease
註釋The burgeoning field of pharmacogenomics holds the promise to uncover genetic risk factors for both rare and common diseases, identify genetically based inter-individual responses to medicines, and enrich clinical trials with more genetically homogeneous groups, with the overarching goal to provide safer and more effective medicines to individuals and populations. With the sequencing of the human genome at the turn of the twentieth century, this last decade has seen an explosion in the development of technologies and methods to advance our understanding of the genetic underpinnings of disease and how individuals respond to medicines. In the field of Alzheimer’s disease research, pharmacogenomics has provided insight into the genetic complexity of this common disorder, confirming ApoE carrier status as a genetic determinant of risk for this disease, as well as identifying many other possible gene candidates. Recognition of global genetic diversity, however, requires that these methods be applied to different ethnic and racial groups throughout the world. Collaborations between academia, non-government organizations, and the pharmaceutical industry under the guidance and regulation of government-directed institutes and initiatives have been created in underdeveloped and developing countries in Africa, Asia, and Central and South America to identify unique genetic variation that will guide the development and use of medicines in these populations. Though each local population and government has its own set of economic, social, legal, regulatory and ethical challenges, the overarching goal in this endeavor is the translation of pharmacogenomic knowledge into the development of safer and more effective medicines for patients throughout the world.