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David Dubins created a free Excel spreadsheet called FARTSSIE (Free Analysis Research Tool for Sample Size Iterative Estimation) to help with clinical trial sample size calculations. FARTSSIE uses equations from statistical literature to calculate sample sizes for various clinical trial designs, including superiority, equivalence, non-inferiority, and bioequivalence trials. Dubins also created a cheat sheet summarizing bioequivalence guidance from regulatory agencies to help with designing bioequivalence studies. He provides the tools and references for free download and welcomes feedback to improve the tools.

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347 views2 pages

Stat Calcu

David Dubins created a free Excel spreadsheet called FARTSSIE (Free Analysis Research Tool for Sample Size Iterative Estimation) to help with clinical trial sample size calculations. FARTSSIE uses equations from statistical literature to calculate sample sizes for various clinical trial designs, including superiority, equivalence, non-inferiority, and bioequivalence trials. Dubins also created a cheat sheet summarizing bioequivalence guidance from regulatory agencies to help with designing bioequivalence studies. He provides the tools and references for free download and welcomes feedback to improve the tools.

Uploaded by

api-3698598
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOC, PDF, TXT or read online on Scribd
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David Dubins, B.A.Sc., Ph.D.

[email protected]

My Tiny Contribution to Clinical Research: FARTSSIE.

Hi, I work in clinical research, specifically in clinical trial design and analysis. I love working things 
out on my own, it's often the best way to understand a phenomena. Sample size calculation is one 
of those finicky niche areas that require precise calculations using expensive statistical package. I 
thought I would develop a free tool to estimate sample sizes, largely based on equations from the 
following reference:

Julious, SA. "Tutorial in Biostatistics ­ Sample sizes for clinical trials with Normal data." Statist. Med
2004; 23:1921–1986.

I've created an Excel spreadsheet that utilizes the equations in a Microsoft Excel workbook, which 
arrives at the same sample sizes as software packages such as SAS, NQuery, and PASS. The 
Excel workbook is called "Free Analysis Research Tool for Sample Size Iterative Estimation".

To download my spreadsheet, click here:

Download FARTSSIE.zip

FEATURES:

• FARTSSIE calculates sample sizes for the following clinical trial designs:
o Superiority Trials: Parallel and 2­way Crossover 
o Clinical Equivalence Trials: Parallel and 2­way Crossover 
o Non­Inferiority Trials: Parallel and 2­way Crossover 
o Bioequivalence Trials: Crossover, Replicate, and Parallel 
o Trials to a Given Precision: Parallel and Crossover 
o Difference Between Proportions (for smaller trials, up to 170 subjects) 
o Variance Correction (baseline correction, post­dose measures correction, or 
both)
• A "boss button" on most trial designs which will work backwards from the sample siz
your boss (or client) wants.
• No annoying advertisements, registration options, or guarantees. 
Bioequivalence Guidance Cheat Sheet

I have also created a "Cheat Sheet" for bioequivalence guidences. This spreadsheet contains 
general recommendations for conducting bioequivalence studies for submission to the FDA, 
Canada, and Europe. I have included the actual text from the guidance documents rather than 
paraphrasing (unless square brackets are indicated) and the references to the guidances used are 
provided on the bottom of the sheet. 

I make no promises about keeping this spreadsheet updated, so please do not use it in place of 
consulting the actual guidances referenced. I developed this spreadsheet because I have a horrible
memory for policies.

Download Bioequivalence Summary Chart in Excel

Feedback
I hope you find this tool useful. Did you manage to install it correctly? Did it work? Is there somethin
you like or dislike about it? Do you have a suggestion that could make it better? Your feedback is 
appreciated. 

   Email Me

Last Updated: 4­Jan­08

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