Meta-analytic Phase I clinical trial
A meta-analytic Phase I clinical trial formally pools evidence from prior Phase I studies — using Bayesian or frequentist meta-analysis — to construct an informative prior (or summary estimate) for dose-toxicity relationships before or during a new first-in-human or early-phase study. The approach increases statistical efficiency, reduces the number of patients exposed to subtherapeutic or toxic doses, and accelerates dose selection by systematically leveraging all relevant historical dose-finding data.
Allikakirje
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- Neuenschwander, B., Capkun-Niggli, G., Branson, M., & Spiegelhalter, D. J. (2010). Summarizing historical information on controls in clinical trials. Clinical Trials, 7(1), 5–18. · DOI 10.1177/1740774509356002
- Jaki, T., Clive, S., & Weir, C. J. (2013). Principles of dose finding studies in cancer: a comparison of trial designs. Cancer Chemotherapy and Pharmacology, 71(5), 1107–1114. · DOI 10.1007/s00280-012-2059-8
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