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Globalization of Alzheimer's disease clinical trials

机译：阿尔茨海默氏病临床试验的全球化

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Alzheimer's disease (AD) therapies are increasingly being tested in global clinical trials. A search of ClincalTrials.gov revealed that of 269 currently active trials, 28% are currently being conducted in the United States; the majority of trials and the majority of trial sites are ex-US. The US has the largest number of trial sites of any single country; cumulatively, nearly half of all sites are outside the US. The US conducts more trials in all phases of drug development but has a greater proportion of phase 3 trials. The increasing importance of global participants in clinical trials emphasizes the importance of considering the ethnic and international factors that may influence trial outcome. The International Conference on Harmonization guidelines divide ethnic factors that may affect drug development into intrinsic and extrinsic influences. These include language, cultural factors, educational levels, the general level of health and standard of care, as well as nutrition and diet. Ethnic influences on pharmacokinetics are known for some metabolic pathways. The biology of AD may also differ among the world's populations. The frequency of the apolipoprotein e4 allele, a major risk factor for AD, differs internationally. Genetic variations might also affect inflammatory, excitotoxic, and oxidative components of AD. Diagnostic standards and experience vary from country to country. Levels of practitioner training and experience, diagnostic approaches to AD, and attitudes regarding aging and AD may differ. Experience and sophistication with regard to clinical trial conduct also vary within and between countries. Experience with conducting the necessary examinations, as well as the linguistic and cultural validity of instrument translations, may affect trial outcomes. Operational and regulatory aspects of clinical trials vary and provide important barriers to seamless conduct of multiregional clinical trials. Collection and testing of biological samples, continuous provision of drug substance, and protection of the integrity of supply lines may be difficult in some international circumstances. Attention to these potential influences on clinical trials will determine the success of global drug development programs and the utility of global trials for developing new AD therapeutics.
机译：阿尔茨海默氏病（AD）疗法越来越多地在全球临床试验中进行测试。对ClincalTrials.gov的搜索显示，在目前进行的269个有效试验中，有28％在美国进行。大多数审判​​和大多数审判​​地点在美国以外。美国拥有单个国家/地区中最多的审判地点;累计而言，将近一半的站点位于美国以外。美国在药物开发的所有阶段都进行了更多的试验，但第三阶段的试验所占比例更大。全球临床试验参与者的重要性日益提高，这凸显了考虑可能影响试验结果的种族和国际因素的重要性。国际协调会议准则将可能影响药物开发的种族因素分为内在影响和外在影响。其中包括语言，文化因素，教育水平，总体健康水平和护理标准以及营养和饮食。种族对药代动力学的影响因某些代谢途径而闻名。 AD的生物学在世界人群之间也可能有所不同。载脂蛋白e4等位基因（AD的主要危险因素）的发生频率在国际上有所不同。遗传变异也可能影响AD的炎症，兴奋性毒性和氧化性成分。诊断标准和经验因国家而异。从业者的培训和经验水平，对AD的诊断方法以及对衰老和AD的态度可能有所不同。在国家内部和国家之间，临床试验行为的经验和技巧也各不相同。进行必要考试的经验以及仪器翻译的语言和文化有效性可能会影响审判结果。临床试验的运营和监管方面各不相同，并为无缝开展多区域临床试验提供了重要的障碍。在某些国际情况下，可能难以收集和测试生物样品，持续提供原料药以及保护供应管线的完整性。注意这些对临床试验的潜在影响将决定全球药物开发计划的成功以及全球试验在开发新的AD治疗药物中的效用。

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