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FARTSSIE is a free sample size calculator for various types of clinical trials (superiority, non-inferiority, equivalence, bioequivalence, etc.).

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INSTALL

FARTSSIE is a standalone Excel macro-enabled file (.xlsm). Installing is not required. Macros need to be enabled for the spreadsheet to function.

If you are downloading FARTSSIE on a Windows 11 operating system, you will need to do the following:

  1. Right-click on the downloaded file
  2. Select "Properties"
  3. In the "Security" section, click "Unblock", then click "Apply".
  4. When you open the file in Excel, click "Enable Content".

Hidden under the visual basic code of FARTSSIE is the version history:

VERSION HISTORY
---------------
Version 3.0: Corrected routine to calculate total CV from published CI for Bioequivalence, Parallel (PowerTOST method).
Version 2.9: Two worksheets were added to estimate the combined dropout rates and buffer the sample size accordingly: "Dropouts - 2 rates", and "Dropouts - 3 rates". Added "RefScaledBE" Worksheet - sample size table for HVDs and NTIDs.
Version 2.8: FARTSSIE moves to Github! TotalCV calculation added to Parallel BE sheet. Prompt for CV on Parallel BE updated to Total CV.
There were a few "quiet" updates for version 2.8 that didn't warrant a version number increase. For instance I think 
Version 2.7: PowerTOST suggested example code corrected.
I finally found and corrected the Error 13 bug on some Mac platforms.
Version 2.6: Added graphs to Parallel BE worksheet, and Mac had some macro issues with Double variable type (changed to Variant).
Version 2.5: Removed Reference-Scaled BE Limits (skewed results at higher CVs, improper method implemented). Added links to PowerTOST.
Version 2.4: Fixed the way that d was depicted on superiority and non-inferiority trials.
Version 2.3: Added Lehr's Formula to parallel superiority
Version 2.2: Added d to the first two graphs, fixed 30% threshold BE limits for HVD (limits would go within 80-125 below 30% ISV)
Version 2.1: Added snazzy distribution graphs
Version 2.0: Added TPD HVD limits, Policy on Bioequivalence Standards for HVD Products 18-Apr-16:
Version 1.9: FDA sigmaw0 changed to 0.294, EMEA widened CI limits constrained to 69.84-143.19%
Version 1.8: Fixed precision of ISV and ratio for BE sheets, updated to .xlsm format
Version 1.7: Added Reference-Scaled BE Limits to Replicate Spreadsheet for FDA
Version 1.6: Added Scaled BE Limits spreadsheet based on FDA recommendations
Version 1.5:
- added power calculator button
Version 1.4: Now compatible with Office 2007. Dr. Russel Lenth generously provided the library subroutines to calculate
- non-central distributions (NCt)
- Warning added on bioequivalence spreadsheets for ratio outside BE limits
- Limit warning at 1000 subjects to prevent needless waiting

I have also added a few random tools I have developed over the years that have been sitting on my hard drive (again, offered as a "free" second opinion). These programs are unvalidated, only lightly tested, and come with no guarantees of cross-platform compatibility or accuracy. Some of them are being used as proof-of-concept programs in the bioequivalence courses I teach at the Leslie Dan Faculty of Pharmacy.

For instance, the bootstrapping programs I posted do not run a single ANOVA. Think "high-school" level standard error. However, they do give surprisingly good agreement with calculated power, and bootstrapping is a stochastic method after all.

“You know," said Arthur, "it's at times like this, when I'm trapped in a Vogon airlock with a man from Betelgeuse, and about to die of asphyxiation in deep space that I really wish I'd listened to what my mother told me when I was young." "Why, what did she tell you?" "I don't know, I didn't listen.” ― Douglas Adams, The Hitchhiker's Guide to the Galaxy (also applicable to my relationship with statistics)

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FARTSSIE is a free sample size calculator for various types of clinical trials (superiority, non-inferiority, equivalence, bioequivalence, etc.).

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