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Although modern clinical trials are traditionally conducted in Western countries, currently there is a shift to involve developing countries, particularly China and India. For these trials, the large population size of India and China means that substantial numbers of individuals affected by rare diseases may be found, increasing the likelihood of successfully completing enrollment in a clinical trial. Furthermore, the increasing involvement of Asian countries in global clinical trials is likely to lead to greater appreciation of the value of evidence-based treatment decisions in the region. These sites are more cost-effective, although this advantage is being eroded over time. Asian participants in clinical trials are also typically more likely to complete study follow-up and procedures, and to adhere to their randomized treatment allocation than individuals from Western countries. Challenges include relevance of the proposed trial to the region, capacity limitations because of undeveloped training, and ensuring research implementation quality and different intellectual property practices. There are specific challenges to conducting clinical trials in India, such as the status of ethics committees, health insurance and coverage for participants, and variability in languages and record-keeping. Challenges in both countries are substantial but are able to be managed with appropriate planning. [ABSTRACT FROM AUTHOR]

Fluoride content in black tea in various commodities, packages, and preparation processess was assayed and its safety evaluated. A fluoride ion selective electrode method was used to determine the fluoride content in 20 tea samples, in various black tea commodities, namely stick-shaped, granular, and canned or bottled tea beverage, originally produced in India, Sri Lanka, China, Japan and UK, and milk–tea after addition of milk and sugar. The fluoride content of 5 stick-shaped black teas was 96.9–148 mg/kg, that of 8 granular black tea was 139–223 mg/kg, and that of 3 canned or bottled beverage black tea beverages was 0.70–0.96 mg/l, respectively. Neither the bagged black tea paper nor the addition of milk and sugar affected the ionic fluoride level within the tea. These results suggest that, for heavy black tea drinkers, the fluoride intake in areas with drinking water fluoridation, and also other probable sources of fluoride, may approach or reach the level of risk from chronic fluoride intoxication. [Copyright &y& Elsevier]