Clinical trials in "emerging markets": regulatory considerations and other factors.
Clinical studies are being placed in emerging markets as part of global drug development programs to access large pool of eligible patients and to benefit from a cost effective structure. However, over the last few years, the definition of "emerging markets" is being revisited, especially from a regulatory perspective. For purposes of this article, countries outside US, EU and the traditional "western countries" are discussed. Multiple factors are considered for placement of clinical studies such as adherence to Good Clinical Practice (GCP), medical infrastructure & standard of care, number of eligible patients, etc. This article also discusses other quantitative factors such as country's GDP, patent applications, healthcare expenditure, healthcare infrastructure, corruption, innovation, etc. These different factors and indexes are correlated to the number of clinical studies ongoing in the "emerging markets". R&D, healthcare expenditure, technology infrastructure, transparency, and level of innovation, show a significant correlation with the number of clinical trials being conducted in these countries. This is the first analysis of its kind to evaluate and correlate the various other factors to the number of clinical studies in a country.
Global Regulatory Affairs and Safety, Amgen, Inc., United States. Electronic address: romi.singh@amgen.com.
Romi
R
Singh
Ouhong
O
Wang
D002986:Clinical Trials as Topic / Q000191:economics / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data; D003906:Developing Countries / Q000706:statistics & numerical data; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence / Q000458:organization & administration; D033161:Government Regulation; D059066:Gross Domestic Product / Q000706:statistics & numerical data; D006801:Humans
Clinical trials; Emerging markets; Regulatory