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. 2024 Sep 16;58(6):1214–1232. doi: 10.1007/s43441-024-00693-8

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© The Author(s) 2024

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

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A framework for determining the likelihood of regulatory acceptance of a Single Arm Study. Footnote: Top of figure shows factors regulatory decisions believed to be less likely (on left) for regulatory acceptance of a single arm trial (SATs), with increasing likelihood for decisions moving to the right of graph. Bottom left part of figure reflects considerations that may increase the likelihood of regulatory acceptance of SATs, while the right side shows those that may decrease likelihood of SAT acceptance, depending on regulatory decision. The scope of this study is novel approvals, indicated on the far left end of the spectrum.