Adverse Event Assessment In India Gets Harvard-Built Tool; Will Increased Trial Activity Follow?
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 new chief of the Indian Society for Clinical Research, Sanish Davis, tells Scrip how the Indian trials segment coped amid pandemic upheaval, emphasizing the need for stakeholder “sensitization and socialization” of the concepts of virtual/hybrid trials as part of efforts to mainstream these. The executive also shared his views on India’s trial waiver clause.
India’s draft new drugs and clinical trials rules come with a prickly "no claims" clause pertaining to payment of “interim compensation” by sponsors in specific circumstances, based on an initial causality assessment by ethics committees (ECs). The new rules, at least in their current form, also give ECs near "quasi- regulatory powers" say some experts.
The debate on the need to reform Indian clinical trial regulations reached a crescendo of sorts at a conference hosted by the Drug Information Association in Mumbai.