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The 2025 New England Rare Disease Statistics (NERDS) workshop, held on October 9-10 in Boston, brought together leading biostatisticians, data scientists, clinical researchers, and regulatory professionals from academia and industry. This workshop served as an important forum for exchanging innovative ideas aimed at addressing the unique statistical and regulatory challenges inherent to rare disease drug research and development. At PROMETRIKA, we continue to advance collective expertise and strengthen our contributions to successful clinical development.
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The objective of phase 1 dose-finding studies is to determine the maximum tolerated dose (MTD), defined as the highest dose at which a pre-specified proportion of subjects experience a dose limiting toxicity (DLT). Ideally, the trial design would not only be easy to implement but also efficient and ethical. In recent years, several statistical models for adaptive trial designs have emerged.
THOUGHT LEADERSHIP
