David Dubins, Ph.D., B.A.Sc. Associate Professor, Teaching Stream Leslie Dan Faculty of Pharmacy 144 College Street Toronto, Ontario M5S 3M2 Lab Website: http://individual.utoronto.ca/ddubins/pharmlab d.dubins@utoronto.ca

My Tiny Contribution to Clinical Research: FARTSSIE. Hi, I used to 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 packages. 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 uses the equations in a Microsoft Excel workbook. The Excel workbook is called "Free Analysis Research Tool for Sample Size Iterative Estimation". Had I known this spreadsheet would travel, I would have given it a less "cheeky" name. To download the latest version of FARTSSIE, click the following link: Download the latest version of FARTSSIE. I now use this spreadsheet in my bioequivalence electives at the Leslie Dan Faculty of Pharmacy, University of Toronto. Visit Dr. Russel Lenth's Website, the person who made this software possible. A much better, more powerful, and open source sample size program is PowerTOST, avalilable here: PowerTOST FEATURES: Version 2.9: Release Date 27-Jan-23 Two worksheets were added to estimate the combined dropout rates and buffer the sample size accordingly: "Dropouts - 2 rates", and "Dropouts - 3 rates" Version 2.8: Release Date 15-Mar-22 TotalCV calculation added to Parallel BE sheet. Prompt for CV updated to Total CV. Fixed Error 13 bug on ISV calculator for OSX Version 2.7: Release Date 10-Mar-21 Corrected PowerTOST suggested code, with thanks to Helmut Schütz. Moved FARTSSIE to github. Version 2.6: Release Date 01-Feb-21 Fixed variable definitions for Mac, and added graphs for Parallel Bioequivalence worksheet. Version 2.5: Release Date 13-Oct-20 Removed all Reference Scaling - Redirect this method to PowerTOST Version 2.4: Release Date 14-Mar-19 Corrected rendering of d on superiority and non-inferiority trials Version 2.3: Release Date 1-Feb-17 Added Lehr's Formula to Superiority, Parallel worksheet Version 2.2: Release Date 1-Feb-17 Added ±d values to graphs, adjusted BE limits for replicate designs Version 2.1: Release Date 16-Jan-17 Added distribution graphs to most spreadsheets Version 2.0: Release Date 11-Jan-17 TPD HIghly Variable Drug BE limit calculation added Version 1.9: Version 1.8: Fixed precision of ISV and ratio for BE sheets Updated to .xlsm format Version 1.7: Version 1.6: Alternate approaches for expansion of BE limits also included: Version 1.5: "Calculate Power" button added to Bioequivalence worksheets Version 1.4: Now compatible with Excel 2007 No extra library to install Opt-out warning at 1001 subjects Bioequivalence warning if expected ratio isn't within BE limits FARTSSIE calculates sample sizes for the following clinical trial designs: Superiority Trials: Parallel and 2-way Crossover Clinical Equivalence Trials: Parallel and 2-way Crossover Non-Inferiority Trials: Parallel and 2-way Crossover Bioequivalence Trials: Crossover, Replicate, and Parallel Trials to a Given Precision: Parallel and Crossover Difference Between Proportions (for smaller trials, up to 170 subjects) Variance Correction (baseline correction, post-dose measures correction, or both) A "boss button" on most trial designs which will work backwards from the sample size your boss (or client) wants. How terrible is that?! No annoying advertisements, registration options, or guarantees.  Feedback I hope you find this tool useful. Did it work? Is there something you liked or disliked about it? Do you have a suggestion that could make it better? Your feedback is appreciated.    Email Me Last Updated: 13-Oct-20