Lilly To Begin Posting All Phase II-IV Trials To ClinicalTrials.gov
This article was originally published in The Pink Sheet Daily
The company is moving beyond the FDAMA requirements that only studies for serious or life-threatening diseases be included on the government-run database. Lilly will begin posting all new trials effective July 1; information for ongoing studies will be posted by Sept. 13.
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PhRMA revises earlier policy, which advised companies to post trials only for “serious and life-threatening” conditions, as mandated by FDAMA. Policy change comes as international trade associations adopt universal principles on clinical trial disclosure.
Website will be expanded in the fourth quarter to include results of Lilly-sponsored clinical trials for marketed products, including Phase III data from failed studies of secondary indications.
FDA is clarifying that it expects sponsors to provide analysis of efficacy data rather than simply a summary of clinical data as part of the integrated summary of effectiveness in new drug applications