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How many (pre-clinical) efficacy and safety data needs to be presented under Heading 1.6?

Answer: 

Section 1.6 of the template ‘Essential information to be provided for proposals including clinical trials...’ requests concise information on safety and tolerability of study interventions: e.g. pre-clinical data from in vitro or in vivo studies; data from previous clinical studies; data from (pharmaco)vigilance systems or other sources. Furthermore provide concise information on efficacy of study interventions based on (pre-)clinical data.