Adaptive Dose-Response Analysis
Adaptive dose-response analysis combines pre-specified dose-response modeling with planned interim looks that allow modifications — such as dropping ineffective doses or reallocating sample size — while maintaining statistical integrity. The most widely cited framework is MCP-Mod (Multiple Comparisons and Modeling), endorsed by the EMA and FDA as a fit-for-purpose methodology for dose-finding studies in drug development.
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- Bretz, F., Pinheiro, J. C., & Branson, M. (2005). Combining multiple comparisons and modeling techniques in dose-response studies. Biometrics, 61(3), 738-748. · DOI 10.1111/j.1541-0420.2005.00344.x
- Bornkamp, B., Bretz, F., Dmitrienko, A., Enas, G., Gaydos, B., Hsu, C. H., König, F., Mohberg, M., Pinheiro, J., Roessner, L., & Smith, M. (2007). Innovative approaches for designing and analyzing adaptive dose-ranging studies. Journal of Biopharmaceutical Statistics, 17(6), 965-995. · DOI 10.1080/10543400701643848
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