The 2nd UMBC–Stanford Workshop
on Clinical Trials and Regulatory Science

Event Summary: A one-day workshop organized by the Center for Interdisciplinary Research and Consulting at the University of Maryland, Baltimore County (UMBC), and the Center for Innovative Study Design (CISD) at Stanford University in the field of Clinical Trials and Regulatory Science.

Registration is now closed

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Organizing Committee:

Faculty from UMBC and Stanford University and leaders from FDA and industry.

For more information: Please contact Dr. Yi Huang, Department of Mathematics and Statistics, University of Maryland Baltimore County (UMBC), 1000 Hilltop Circle, Baltimore, MD 21250.
E-Mail: yihuang@umbc.edu.

For any Technical difficulties Please contact Zana Coulibaly at czana1@umbc.edu.


Participant Information

Vlad Dragalin from Janssen.

Paper: Two-stage designs in dose-finding studies

Adaptive two-stage designs may increase efficiency in Phase 2 from several perspectives. Futility stopping may be used to combine the proof-of-concept and dose-response evaluation objectives of Phase 2 within one study. Instead of running separate proof of concept and dose-finding studies, the effect of the drug may be established and the dose response may be estimated within a single efficient study. The uncertainty on the dose-response, which might be present at the beginning of Phase 2 is well addressed with potential adaptation of subject allocation in the second stage. A simulation study will be presented showing that a single adaptation after the first stage may significantly enhance the identification of the interesting part of the dose response curve and improve accuracy of its estimation. Moreover, a futility rule at the end of the first stage reduces the resource allocation to ineffective drugs.


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