Stata and FDA regulatory compliance

Attention: On 18 March 2020, the U.S. Food and Drug Administration issued a guidance for industry conducting clinical trials during the coronavirus (COVID-19) pandemic. See www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-guidance-conducting-clinical-trials and the corresponding document.

The U.S. Food and Drug Administration (FDA) accepts new drug applications and medical device trials performed using Stata. Although the FDA does not require use of any specific software for statistical analyses, they emphasize in their Statistical Software Clarifying Statement that:

"The computer software used for data management and statistical analysis should be reliable, and documentation of appropriate software testing procedures should be available.”

Stata satisfies these requirements and is one of the most respected and validated statistical tools for analyzing clinical data from pre-clinical through phase IV trials. At each step of analysis, you can rely on Stata’s extensive suite of statistics, data management, and graphics tools to provide accurate and reproducible results. We take reproducibility seriously. Stata is the only statistical package with integrated versioning. If you wrote a script to perform an analysis in 1985, that same script will still run and still produce the same results today. The same is true for any dataset you create.

When you submit an application using data and results from clinical trials, the FDA requires you to verify the validity of your data and analyses. See FDA guidelines relating to statistical software. Stata offers features that will help you comply with these guidelines:

• An intuitive and easy-to-use Installation Qualification tool that produces a report suitable for submission to regulatory agencies, such as the FDA, verifying that Stata has been installed properly.
• An extensive set of manuals detailing the syntax, use, formulas, references, and examples for all of the commands in Stata.
• An extensive software certification suite testing the computational validity of Stata's commands and Stata's ability to maintain integrity.
  
  Stata has millions of lines of certification code verifying the estimation and numerical results, output, command syntax, and stability of results across different platforms. Certification is run on all supported platforms (Windows, Mac, Linux, etc.) every time a new release of Stata (or any subsequent free update) is sent to users. Any discrepancies between previously-established results, output, behavior, or performance are automatically flagged and reviewed by statisticians and software engineers before the updated software is made available to users. See Certification results.
  
  In addition, Stata's accuracy is verified by running the National Institute of Standards (NIST) StRD numerical accuracy tests and the George Marsaglia Diehard random-number generator tests.
• Stata is the only statistical package with integrated versioning. If you wrote a script to perform analysis in 1985, that same script will still run and still produce the same results today. Any dataset you created in 1985, you can read today. And the same will be true in 2050. Stata will be able to run in the future anything you do today.
• All free updates to Stata can be easily obtained by users or administrators securely over the Internet. All changes are documented in Stata's help system. Users can type help whatsnew or select Help > What's New? from the menu to see, listed by date, all changes that have been made to Stata and included in the currently installed update (as well as previous updates).
• Stata has an excellent worldwide reputation for accuracy and quick resolution of all questions. Our world-class technical support staff consists of PhD- and master's-level statisticians and expert Stata programmers.
• Seamless verification that data have not changed using the datasignature suite of commands.

Also see Why Stata for more reasons to use Stata for your regulatory submissions.

FDA guidelines relating to statistical software

When you submit an application using data and results from clinical trials, the FDA requires you to verify the validity of your data and analyses. Also required is adherence to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals in Human Use (ICH) guidelines. We list some of the guidelines relating to statistical software below.

• 21 CFR Part 11—Electronic Records; Electronic Signatures
• Guidance for Industry: Part 11, Electronic Records; Electronic Signatures—Scope and Application
• ICH E6—Good Clinical Practice: Integrated Addendum to ICH E6(R1)
• Computerized systems used in clinical investigations
• General principles of software validation
• Statistical principles for clinical trials
• Simulation and computational studies results
• Guidance for the use of Bayesian statistics in medical device clinical trials
• For other guidelines

This list is not exhaustive. You may not find the exact guidelines you need for your clinical trial. Regardless of your clinical trial requirements, Stata has features that will help you comply with them.