Stat Calcu
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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
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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