FDA Guidance: Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations

The FDA finalized a guidance it originally released in 2012 that is aimed to help industry collect safety data in late-stage premarket and postapproval clinical investigations. The FDA says in the guidance that selective safety data collection may be possible for some late-stage premarket and postapproval clinical investigations because "certain aspects of a drug's safety profile will be sufficiently well-established and comprehensive data collection is not needed." Safety Databases Safety databases collect information to accurately assess and characterize the risks of a new drug. A sponsor collects safety-related data during the course of drug development and knowledge of a drug's safety profile can change as more information comes in through its lifecycle. However, FDA notes that encouraging selective safety data collection in late-stage premarket and postapproval clinical investigations is consistent with the agency's approach to safety assessment which is focused on information that is useful and adds to current knowledge. FDA outlines the growing interest in larger, simpler trials to obtain outcome data, data on long-term effects of drugs, and data on comparative effectiveness and safety. According to the agency, excessive safety data collection may discourage the conduct of these types of trials by increasing the resources needed to perform them and be a disincentive to investigator and patient participation in clinical trials. Therefore, FDA believes its guidance...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs