Bridging Data between Two Ethnic Populations. A New Application of Matched Case-Control Methodology
Utilizing foreign clinical data from a large-scale trial to draw conclusions about the safety and efficacy of a drug in a new region will eliminate the need to repeat a large-scale clinical trial in the new region. This approach is not only cost-effective; it expedites the approval of valuable new drugs, so subjects in the new region can benefit sooner from new therapies that are currently helping millions of people worldwide. The International Conference on Harmonization (ICH) E-5 guideline (ICH Harmonized Tripartite Guideline E-5: Ethnic factors in the acceptability of foreign clinical data,) indicates that a bridging study can be performed in a new region to provide efficacy, safety, and dosage information and allow subsequent extrapolation of foreign clinical data to the population in that new region. However, this definition does not identify appropriate statistical methods for “bridging” the two populations. The statistical method proposed in this article selects subjects from the global population who have characteristics similar to those of subjects in the new region. These methods have been used in other applications, but not to bridge data. The paper describes a new application of this methodology and evaluates other methodologies proposed for bridging. An example of how the proposed methodology can be used to bridge global clinical trial data to a new population is also provided.
Key WordsBaseline demographics Bridging study Clinical trial Propensity score Statistical methodology
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- 1.International Conference on Harmonization Expert Working Group. ICH Harmonized Tripartite Guideline: Ethnic Factors in the Acceptability of Foreign Clinical Data. International Conference on Harmonization; 1998.Google Scholar
- 2.Marcus R, Holloway L, Wells B, Greendale G, James MK, Wasilauskas C, et al. The relationship of biochemical markers of bone turnover to bone density changes in postmenopausal women: results from the Postmenopausal Estrogen/Progestin Interventions (PEPI) trial. J Bone Miner Res. 1999;14:1583–1595.CrossRefGoogle Scholar
- 4.Johnston CC Jr, Bjarnason NH, Cohen FJ, Shah AS, Lindsay R, Mitlak BH, et al. Long-term effects of raloxifene on bone mineral density, bone turnover, and serum lipids in early postmenopausal women. 3-year data from two double-blind, randomized, placebo-controlled trials. Arch Int Med. 2000;160(22): 3444–3450.CrossRefGoogle Scholar
- 5.Rosenbaum PR, Rubin DB. Constructing a control group using multivariate matched sampling methods that incorporate the propensity score. Am Statistician. 1985;39:33–38.Google Scholar