1. Pink Sheet

Adverse Event Assessment In India Gets Harvard-Built Tool; Will Increased Trial Activity Follow?

 
• By Anju Ghangurde

Against backdrop of subdued trial activity in the country and concerns about injury compensation, Indian Society for Clinical Research and Harvard's MRCT Centre offer a portal to facilitate a more objective assessment of causality of serious adverse events.

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The Indian Society for Clinical Research (ISCR) has developed a causality assessment portal in collaboration with Harvard University's Multi-Regional Clinical Trials (MRCT) Center which it hopes will facilitate a more “reasoned” evaluation of the likelihood of a causal connection between an investigational medicine and an adverse event in trials.

An endorsement of the tool by the country's regulators (and there are some encouraging early signs) could, alongside other ongoing...

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