Single-arm phase II trials can provide compelling results that facilitate the approval of a new therapy. Designing and interpreting single-arm studies based on four principles — instinct, comparative analysis, statistical soundness and like-for-like comparisons — can provide indications as to which drugs are most likely to provide improved therapeutic options for patients.
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R.H.G. is an employee of Credit Suisse Securities. The other authors declare no competing interests.
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Glassman, R.H., Kim, G. & Kahn, M.J. When are results of single-arm studies dramatic?. Nat Rev Clin Oncol 17, 651–652 (2020). https://doi.org/10.1038/s41571-020-00429-1
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DOI: https://doi.org/10.1038/s41571-020-00429-1
