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Bridging Studies - What Questions Should be Asked in Phase I Clinical Research?

Inter-ethnic, head-to-head, pharmacovariance or bridging: although they may sound very different, essentially these types of study have the same objective - to provide integrated clinical data towards a new ethnic region regulatory dossier, thus allowing the extrapolation of foreign clinical data for regulatory submission - to bridge the gap between data obtained in distinct ethnic regions. Japan does not have access to some latter generation drugs, which offer marked therapeutic advantages, because the high development costs are generally not justified by the potential market size (1).

Consequently, patients rely on more dated treatments. The desire to extend the market value of a licensed drug to closed regions like Japan ensures that the industry is effectively reaching a previously untapped market at a reasonable cost. In order to redress this balance, Japan, the EU and the US independently proposed regulations to increase the acceptability of foreign data in support of market licences, back in the 1980s.

These independent regulations were brought together in the 1990s by the E5 Expert Working Group of the International Conference on Harmonisation (ICH). The purpose of ICH E5 (Guideline on Ethnic Factors) (2) is to expedite the global development and availability of new medicinal products without impacting established safeguards relating to quality, safety and efficacy between ethnic populations. Assuming that regulatory requirements for the new region are met, bridging data is required to investigate the possibility of ethnic difference between populations in distinct geographical regions. The need for bridging foreign data requires that the following is considered:


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By Dr Jцrg Tдubel, Managing Director of Richmond Pharmacology

Dr Jцrg Tдubel, MD MFPM, is the Managing Director of Richmond Pharmacology, a Phase I CRO conducting human clinical research for pharmaceutical companies. To date he has conducted more than 200 Phase I and early Phase IIa studies in patients and healthy volunteers, and has been co-investigator for at least 150. His experience ranges from simple bioequivalence to complex pharmacokinetic and pharmacodynamic studies, often administering compounds first in man, and his particular interest is gastroenterology and bridging studies. Dr Tдubel is a leading expert in running bridging studies and is regularly invited to write articles and present on the issues surrounding these complex studies.

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Dr Jцrg Tдubel
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