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
reproducible results. We take reproducibility seriously. Stata is the only statistical package with
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
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:
Also see Why Stata for more reasons to use Stata for your regulatory submissions.
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.
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.