Impact of the Ich Guideline on Ethnic Differences
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IMPACT OF THE ICH GUIDELINE ON ETHNIC DIFFERENCES HELENEDUMITRIU, PHD Bayer AG, Wuppertal, Germany
This paper discusses the recent Step 2 document of the International Conference on Harmonization on ethnic factors in the acceptability of foreign clinical data and its possible impact on industry. Key Words: Ethnic differences; Foreign clinical data; Bridging studies
HISTORY HISTORICALLY, ETHNIC MINORITIES, but also women, the elderly, and the poor, have been underrepresented in clinical trials (1). Hence, there is a fear that insufficient data exist to accurately assess the safety and efficacy of new medicinal products in minorities or ethnic groups other than those originally studied. The present draft consensus guideline of March 6, 1997 on “Ethnic Factors in the Acceptability of Foreign Clinical Data” of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has reached Step 2, which means it has been transmitted to the three regions: European Union (EU), Japan, and the United States for consultation. Thorough discussions had taken place before that-it is based on draft 17 of March 1997, showing the complexity of the task.
PURPOSE What is the purpose of the guideline and why might it be said to deal as much with
Presented at the DIA 9th Annual Euromeeting, May 26-28, 1997, Dtisseldod, Germany. Reprint address: Dr.Helene Dumitriu, PbD, Bayer AG, Aprather Weg, D-42096 Wuppertal, Germany.
differences in medical culture as with ethnic differences? The guideline states that: “The purpose of this guidance is to facilitate the registration of medicines among ICH regions* by providing a framework for evaluating the impact of ethnic factors* upon a drug’s effect, ie, its effcacy and safety at a particular dosage* and dose regimen.* It provides guidance with respect to regulatory and development strategies that will permit adequate evaluation of the influence of ethnic factors while minimizing duplication of clinical studies and supplying medicines expeditiously to patients for their benefit. For the purpose of this document, ethnic factors are defined as those factors relating to the genetic and physiologic (intrinsic*)and the cultural and environmental (extrinsic*) characteristicsof a population . . . ” (The asterisk refers in the original to definitions in the glossary.)
In fact, the new guideline describes regulatory strategies that facilitate acceptance of foreign clinical data in other regions; the use of bridging studies, if necessary, to allow extrapolation of data; and developmental strategies with regard to ethnic factor influences on safety, efficacy, dosage, and dose regime. Ethnic differences have now been formally divided into extrinsic factors and intrinsic influences. Actually the guideline should be called just “Acceptability of foreign clinical data,”
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