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Conducting Clinical Trials in Emerging Markets
Informa Healthcare, Jan 2007, Pages: 201
GCPjs report, Conducting Clinical Trials in Emerging Markets is the essential resource for strategists and global trial planners. It enables useful comparisons to be drawn on key performance indicators, such as population statistics, healthcare provision, clinical trial activity and FDA inspection findings.
It focuses on pharmaceutical clinical trials, and is laid out by region, and then by country, making it invaluable for anyone involved in global clinical research programmes.
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.
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