Summary
This report is intended for those engaged in pharmaceutical clinical trials from all different areas of the industry who are interested in starting or expanding their clinical trials activity in emerging markets. The introduction begins with a definition of which countries and regions will be addressed and discusses the general reasons why companies are conducting trials in these countries Those familiar with some or all of the regions will immediately recognise that some countries included in this report are not 'emerging'. However, a significant number of people would regard any one of the countries in this report as emerging and therefore they have been included As there is a potentially very large body of information about emerging markets, the introduction also covers which types of information are included and which have had to be left out. Finally, there is an explanation of the standard country tables that are repeated throughout the report Emerging countries tend to be highly similar in regard to patient recruitment drivers, investigator site staff training and partner selection.
This is even more the case at the regional level for some areas. Therefore, even those only interested in a single country are recommended to read the report introduction and regional chapter opening. These give general information concerning all countries and a discussion on the information content to each country The countries are then discussed by regional chapter. Each country has a section describing the healthcare system and a section concerning the specifics of conducting clinical trials, followed by a section on current clinical trial activity. The amount of information on each country depends on the relative importance of the country to the sector and the amount of information that is available. For some regions where there is a high degree of homogeneity, more information is given at the regional level at the start of the chapter. For most countries, there is a divide between the official regulatory information and practical aspects of conducting clinical trials Most emphasis has been placed on the key countries of China and India plus, to a lesser extent, Russia The discussion and summary is handled under the categories of patients and healthcare, investigator staff, regulations, clinical research associates (CRAs) and the business environment and costs. The summary emphasises how similar the emerging countries are, albeit at different stages of emergence. Again, therefore, it is advised that this section be read, even by those only interested in one country. Some conclusions are then drawn as to the relative strengths of countries and their potential Lastly, this is a very broad topic. For some countries, there is only limited information available in English. For most, the regulations are constantly changing. The author would welcome feedback on the text.
About the author Peter Motteram originally trained in biochemistry at the Universities of Birmingham and London, and has worked in the pharmaceutical and contract research industries for 20 years. After working in a London teaching hospital, he started his pharmaceutical work at Sterling Research Group as a GCP quality assurance auditor. He subsequently held senior positions with Quintiles in quality assurance and business development, and in ClinTrials Research and as general manager for non-Americas. Since 1997 he has worked as a consultant, including advising companies on their growth and outsourcing strategies for extending geographic clinical trials capability. Peter has particular expertise in India and Central and Eastern and a network of opinion leader and expert contacts around the globe
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