The Single Controlled Trial: Industry Survey Indicates that Implementation is Still a Work in Progress
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Drug Informarion Joumol. Vol. 36, pp. 29 1-302, 2002 Printed in the USA. All rights reserved.
THE SINGLE CONTROLLED TRIAL: INDUSTRY SURVEY INDICATES THAT IMPLEMENTATION IS STILL A WORK IN PROGRESS CHRISTOPHER-PAULMILNE,DVM,
MPH, JD
Assistant Director, Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts
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 suflcient. 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. Key Words: Single controlled trial; Effectiveness; Food and Drug Administration Modern-
ization Act of 1997 always necessary to claim effectiveness and that advances in the science and practice of THE AND Drug Administration drug development may permit an expanded Modernization Act Of 1997 (FDAMA) in- role for the so-called single controlled trial cluded a provision (section 115) stating that in contemporary clinical development. under certain circumstances, data from one The origin of the single controlled trial adequate and well-controlled clinical investiseems to have links back to both the Center gation and confirmatory evidence may be for Biologics Evaluation & Research (CBER) sufficient to establish effectiveness for FDA and the Center for Drug Evaluation & Reapproval of drug and biological products. In search (CDER) within FDA. This provision so doing, Congress and FDA have officially essentially codified an FDA policy that had recognized that multiple clinical trials are not existed for a number of years, but whose application had been limited to some biological products and a few pharmaceuticals for Reprint address: Christopher-Paul Milne, DVM, MPH, the treatment of cancer, lung disease, heart JD. Assistant Director, Tufts Center for the Study of disease, and especially AIDS (1). Drug Development, Tufts University, 192 South Street, During the imp1ementation Of the e x p Suite 550. Boston. MA 02111. E-mail: christooher. mihe@ tufrs.edu. dited approval program, FDA demonstrated
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its willingness to base approval of drugs for AIDS patients on a single pivotal study (2). In biologics regulation, the standard was safe, pure,
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