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The implications for europe of revised FDA guidelines for clinical trials with anti-infective agents

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Abstract

This article summarizes the current collaborative effort between the US Food und Drug Administration and the Infectious Diseases Society of America for the purpose of generating new General and Disease/Organism Specific Guidelines for the evaluation of anti-infective agents. Examples of proposed changes from draft documents are presented. The final documents may assist European colleagues in their efforts to establish a standardized new drug registration process by 1992. An area of mutual interest is the acceptability of safety and efficacy data from international clinical trials. In the interest of human and financial economies, both US and European Guidelines need to clarify the conditions, or criteria, for the conduct of valid ‘off-shore’ clinical trials.

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Authors and Affiliations

  1. Providence Medical Center and Oregon Health Sciences University, 4805 NE Glisan St., 97213, Portland, Oregon, USA

    D. N. Gilbert

  2. Veterans Administration Medical Center and State University of New York at Buffalo, Buffalo, New York, USA

    T. R. Beam

  3. Ohio State University, Columbus, Ohio, USA

    C. M. Kunin

Authors
  1. D. N. Gilbert
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  2. T. R. Beam
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  3. C. M. Kunin
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Gilbert, D.N., Beam, T.R. & Kunin, C.M. The implications for europe of revised FDA guidelines for clinical trials with anti-infective agents. Eur. J. Clin. Microbiol. Infect. Dis. 9, 552–558 (1990). https://doi.org/10.1007/BF01964302

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  • DOI: https://doi.org/10.1007/BF01964302

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