Updated on 13 August 2013
FDA’s new norms are seen as an attempt mute widespread industry criticism of the regulator over its stringent on-site data monitoring norms that escalate the cost of trials besides adding to more development time cycles.
Singapore: In a move that will reduce time and cost of bringing new drugs to market, America's drug regulator, Food and Drugs Agency (FDA) has introduced new clinical trial guidelines that encourages and approves more centralized, risk-based monitoring of data instead of costly and time-consuming on-site data verification.
The new guidance norms, an updated versions of FDA's 2011 clinical trials guidelines, were unveiled on August 7,2013. It is called, " Oversight of clinical investigation-a risk-based approach to monitoring." Earlier, FDA had preferred 100 per cent on-site verification clinical trials data by companies that do this work for pharma firms. The new guidance applies for all trials of drugs, biologicals and medical devices.
FDA's new norms are seen as an attempt mute widespread industry criticism of the regulator over its stringent on-site data monitoring norms that escalate the cost of trials besides adding to more development time cycles. Industry insider estimate that about 10 per cent of the costs of a new drug development is attributed to on-site verification costs. Modern drug trials take place across many continents and multiple far-flung locations.
Now FDA is okay with drug sponsors taking up on-site verification of clinical trial data generated only at sites considered to be risk-prone to manipulation. For all other cases, centralized monitoring of data using various technology tools are preferred.
FDA says incorporation of centralized monitoring practices, where appropriate, should improve a sponsor's ability to ensure the quality of clinical trial data. " Several (research) publications suggest that certain data anomalies such as fraud, including fabrication of trial data, and other non-random data distributions may be more readily detected by centralized monitoring techniques than by on-site monitoring."