Lilly To Begin Posting All Phase II-IV Trials To ClinicalTrials.gov
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
You may also be interested in...
ClinicalTrials.gov Postings Should Include Studies For All Diseases – PhRMA
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.
LillyTrials.Com Database Will Disclose Study Results For Marketed Products
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.
NDAs Should Include More Cross-Study Analysis, FDA Says In Draft Guidance
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