PowerTOST & FDA [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2022-09-01 18:31 (93 d 19:22 ago) – Posting: # 23256
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Hi Willem,

❝ Could you elaborate on your note of the use of PowerTOST by FDA? It would provide me an additional argument for using PowerTOST for formal sample size estimation in our company.


Maybe this post helps.

About the validation of PowerTOST with examples:See this document1 about the acceptability of Base R. R is updated every couple of months with documented changes2 and maintaining a bug-tracking system.3 I recommend to use always the latest release.

The authors of PowerTOST tried to do their best to provide reliable and valid results. The package’s NEWS-file documents the development of the package, bug-fixes, and introduction of new methods. Issues are tracked at Git­Hub (as of today none is still open). So far the package had ≈93,000 downloads. Therefore, it is extremely unlikely that bugs were not detected given its large user base.

However, the ultimate responsibility of validating any software (yes, of SAS as well…) lies in the hands of the user.

  1. The R Foundation for Statistical Computing. A Guidance Document for the Use of R in Regulated Clinical Trial Environments. Vienna. October 18, 2021. Online.
  2. The R Foundation. R News. 2022-04-22. Online.
  3. Bugzilla. R bug tracking system. Online.
  4. WHO. Guidance for organizations performing in vivo bioequivalence studies. Geneva. May 2016. Technical Report Series No. 996, Annex 9. Section 4.4. Online.
  5. FDA, CDER/CBER. E9 Statistical Principles for Clinical Trials. Rockville. September 1998. Section V.H. Download.
  6. FDA. Statistical Software Clarifying Statement. May 6, 2015. Download.

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