The Single Controlled Trial: Industry Survey Indicates That Implementation is Still a Work in Progress

Abstract

The Food and Drug Administration Modernization Act of 1997 amended the standard of approval for effectiveness by providing that under certain circumstances, one adequate and well-controlled clinical investigation and confirmatory evidence would be sufficient. The standard of effectiveness has been a point of contention throughout the modern history of drug development and remains so today. With the imminent need to consider the reauthorization of the Prescription Drug User Fee Act, the implementation of the Food and Drug Administration Modernization Act of 1997 will also be open to discussion. In anticipation of the upcoming Congressional and public debate surrounding these laws, the Tufts Center for the Study of Drug Development conducted a survey of nearly 50 of the leading pharmaceutical and biotechnology firms in order to assess the level and manner of utilization of the single controlled trial at the outset of the Food and Drug Administration Modernization Act of 1997 to serve as a frame of reference for these discussions.

Keywords

Single controlled trial Effectiveness Food and Drug Administration Modernization Act of 1997

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