In Multinational Trials, U.S. Often Lags In Efficacy, FDA Analysis Finds
Executive Summary
As drug developers continue to move clinical trials overseas, FDA is keeping a close eye on the differential results that sometimes arise between U.S. and foreign subject populations, potentially affecting the usability of hard-won data for drug applications.
You may also be interested in...
Clinical Data Quality As Good in Developing World As in Developed World – Study
Concerns that sites located in the developing world may not produce reliable data do not appear to be justified, judging by the rate of queries from sponsors to such sites.
Vivitrol's Opioid Abuse Claim Will Likely Need Monitoring and Support Services
FDA's Psychopharmacologic Drugs Advisory Committee voted in favor of expanding the indication for Alkermes' alcoholism treatment by lopsided margins, with the caveat that monitoring and support must be provided to patients.