Article
introduction to dose escalation in early oncology trials and regulatory aspects
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Published: | February 26, 2021 |
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Outline
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Early studies in oncology are often designed to find the dose to be further evaluated in the clinical development program. Such trials are exploratory, and are mainly focused on safety aspects. Uncertainties at the planning stage are encountered with flexible designs and continuous evaluation of analyses during the conduct of the study. This is challenging for sponsors as well as regulators who have to find a balance between adaptability and prespecification. The talk will give a brief introduction to basic methods to guide dose escalation in light of the regulatory perspective.
The authors declare that they have no competing interests.
The authors declare that an ethics committee vote is not required.