Clinical testing
Suggestions for Drug Approvals
14/09/10 14:41 Filed in: GenomeWeb Daily Scan
Blogger Derek Lowe in the Pipeline ackowledged that a regulatory system for approving new drugs is certainly necessary, but wondered whether instead of a system that makes binary decisions, an adaptive system would be better that makes faster decisions based on the data, that are then modified accordingly when additional findings come out. S. Pelech cautions that it is possible that drugs used for treatment of chronic conditions might have much wider dispersion before it is realized that they can have very serious longer-term side-effects in a significant portion of users. He also emphasizes the need for clinical testing of drug combinations, which may become more difficult as the number of possibilities escalates with the appearance of promising new drugs and the number of available patients for a specific trial declines with the identification of more biomarkers to stratify them. Read More...