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Indian court sets 3-parameter format for trial applicants

 
• By Anju Ghangurde

India's Supreme Court has ordered the specific inclusion of three parameters when seeking information from applicants for trials in India. They are the assessment of risk versus benefit to the patients, innovation vis-à-vis existing therapeutic option, and unmet medical need in the country.

India's Supreme Court has ordered the specific inclusion of three parameters when seeking information from applicants for trials in India. They are the assessment of risk versus benefit to the patients, innovation vis-à-vis existing therapeutic option, and unmet medical need in the country.

The order dated 21 April, but only just posted online by the Supreme Court, said that the specific inclusion in the format was meant to "obviate any controversy in future"...

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