By Jen-pei Liu, Shein-Chung Chow, Chin-Fu Hsiao
This booklet presents a complete and unified precis of the transforming into literature and examine actions on regulatory requisites, medical and sensible concerns, and statistical method referring to the layout and evaluate of bridging reviews, which offer pharmacodynamic or scientific info that permit extrapolation of the overseas medical information to a brand new zone. in addition to an intensive review of bridging experiences, the textual content addresses concerns coming up from bridging reviews, together with ethnic sensitivity, necessity of bridging experiences, varieties of bridging stories, and review of similarity b. Read more...
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Extra resources for Design and analysis of bridging studies
Let S be a consistency statement. P(S) is called the assurance probability (Uesaka, 2009). The total sample size is determined by the desirable power of the overall effect. Given this total sample size, the sample size distribution across the regions also impacts the assurance probability for consistency assessment. In addition, consistency assessment is meaningful only when the overall treatment effect is significant. Therefore, for trial design, we may also be interested in the relationship between sample size distribution across the regions and the conditional probability of showing treatment effect consistency given a significant overall treatment effect.
These trials also provide a way for local regulatory authorities to evaluate the medical product using a large body of data including the local countries’ own patients studied with the same standard and hence the possibility of making the drug available to their patients around the same times as other regions. Because of these advantages, participating in a global clinical trial is a recent trend for many nations as a popular alternative to conducting a bridging study. There are two main aims in a global clinical trial.
Bridging Diversity: Extrapolating Foreign Data to a New Region 15 References Caraco, Y. (2004). Genes and the response to drugs. New England Journal of Medicine, 351(27): 2867–2869. Chow, S. , and Shao, J. (2006). On non-inferiority margin and statistical tests in active control trials. Statistics in Medicine, 25: 1101–1113. Chow, S. , and Hu, O. Y. P. (2002). Assessing sensitivity and similarity in bridging studies. Journal of Biopharmaceutical Statistics, 12: 385-400. , Luis, A. , Espiritu, A.