<p><div><div><div><div data-show-faces="false" data-height="21" data-width="100" data-layout="button_count" data-send="true" data-href="https://www.r-bloggers.com/how-r-is-used-by-the-fda-for-regulatory-compliance/"></div></div><div></div></div><div></div></div>
<div>
(This article was first published on <strong><a href="http://blog.revolutionanalytics.com/2017/06/r-fda.html"> Revolutions</a></strong>, and kindly contributed to <a rel="nofollow" href="https://www.r-bloggers.com/">R-bloggers)</a> </div>
<div>
<p>I was recently alerted (thanks <a rel="nofollow" href="https://twitter.com/ma_salmon" target="_blank">Maëlle</a> and <a rel="nofollow" href="https://twitter.com/bearloga" target="_blank">Mikhail</a>!) to an enlightening presentation from last years' useR! conference. (<a rel="nofollow" href="https://user2017.brussels/" target="_blank">This year's useR! conference</a> takes place next week in Belgium.) Paul H Schuette, Scientific Computing Coordinator at the FDA Center for Drug Evaluation and Research (CDER), talked about how <a rel="nofollow" href="https://channel9.msdn.com/Events/useR-international-R-User-conference/useR2016/Using-R-in-a-regulatory-environment-FDA-experiences" target="_blank">R is used in the process of regulating and approving drugs at the FDA</a>. </p>
<p>In what has become a <a rel="nofollow" href="http://blog.revolutionanalytics.com/2012/06/fda-r-ok.html" target="_blank">common theme of FDA presentations at R conferences</a>, Schuette refutes the fallacy that SAS is the only software that can be used for FDA submissions, by sponsors such as pharmaceutical companies. On the contrary, he says &quot;sponsors may propose to use R, and R has been used by some sponsors for certain types of analyses and simulations (post-market).&quot;</p>
<p>The myth persists despite the <a rel="nofollow" href="https://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm445917.htm" target="_blank">FDA's Statistical Software Clarifying Statement</a> declaring that any suitable software can be used. This is probably because some data-exchange regulations do require the use of the &quot;XPT&quot; (also known as SAS XPORT) file format, but that data format is an <a rel="nofollow" href="http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM199759.pdf" target="_blank">open standard</a> and not restricted to SAS. XPT files can be read into R with the built-in <a rel="nofollow" href="https://www.rdocumentation.org/packages/foreign/versions/0.8-69/topics/read.xport?tap_a=5644-dce66f&tap_s=10907-287229" target="_blank">read.xport</a> function, and exported from R with the <a rel="nofollow" href="https://www.rdocumentation.org/packages/SASxport/versions/1.5.3/topics/write.xport?tap_a=5644-dce66f&tap_s=10907-287229" target="_blank">write.xport</a> function in the <a rel="nofollow" href="https://mran.microsoft.com/package/SASxport/" target="_blank">SASxport</a> package. (If you have legacy data in other SAS formats, here's a handy <a rel="nofollow" href="http://biostat.mc.vanderbilt.edu/twiki/pub/Main/Hmisc/exportlib.sas" target="_blank">SAS macro to export XPT files</a>.) The R Foundation also provides guidance on how R complies with other FDA regulations in the document <em><a rel="nofollow" href="http://www.r-project.org/doc/R-FDA.pdf" target="_blank">R: Regulatory Compliance and Validation Issues A Guidance Document for the Use of R in Regulated Clinical Trial Environments</a></em><em>. </em></p>
<p>In addition to sponsors using R in submission, R is also used internally at the FDA. Statisticians there may use the statistical package of their choice, provided it's fit for the purpose. The software used includes SAS, R, Minitab and Stata. Schuette notes that R is used specifically for:</p>
<ul>
<li>Statistical review of data analysis in clinical trial submissions. The primary goal here is, &quot;Can we, on our own, replicate the conclusions of the sponsor?&quot;</li>
<li>Methodology development, innovation and evaluation.</li>
<li>Graphics (in some cases, the detailed information folded and included with prescription medications feature R graphics).</li>
<li>Simulations.</li>
<li>The <a rel="nofollow" href="https://open.fda.gov/" target="_blank">openFDA initiative</a>, including this <a rel="nofollow" href="https://openfda.shinyapps.io/LRTest/" target="_blank">LRT Signal Analysis for a Drug</a> Shiny application.</li>
</ul>
<p>Check out the entire presentation, embedded below.</p>
<p><iframe width="450" allowfullscreen="" src="https://channel9.msdn.com/Events/useR-international-R-User-conference/useR2016/Using-R-in-a-regulatory-environment-FDA-experiences/player" height="288"></iframe></p>
<p>Channel 9: <a rel="nofollow" href="https://channel9.msdn.com/Events/useR-international-R-User-conference/useR2016/Using-R-in-a-regulatory-environment-FDA-experiences" target="_blank">Using R in a regulatory environment: FDA experiences</a>.</p>
<p> </p>
</div>
	<p>
<div>
<div>To <strong>leave a comment</strong> for the author, please follow the link and comment on their blog: <strong><a href="http://blog.revolutionanalytics.com/2017/06/r-fda.html"> Revolutions</a></strong>.</div>
<hr>
<a rel="nofollow" href="https://www.r-bloggers.com/">R-bloggers.com</a> offers <strong><a rel="nofollow" href="https://feedburner.google.com/fb/a/mailverify?uri=RBloggers">daily e-mail updates</a></strong> about <a rel="nofollow" href="https://www.r-project.org/" title="The R Project for Statistical Computing">R</a> news and <a rel="nofollow" href="https://www.r-bloggers.com/search/tutorial" title="R tutorials">tutorials</a> on topics such as: <a rel="nofollow" href="https://www.r-bloggers.com/search/data%20science" title="Data science">Data science</a>, <a rel="nofollow" href="https://www.r-bloggers.com/search/Big%20Data" title="Big Data">Big Data, <a rel="nofollow" href="https://www.r-users.com/" title="R jobs">R jobs</a>, visualization (<a rel="nofollow" href="https://www.r-bloggers.com/search/ggplot2" title="ggplot and ggplot2 tutorials">ggplot2</a>, <a rel="nofollow" href="https://www.r-bloggers.com/search/boxplot" title="Boxplots using lattice and ggplot2 tutorials">Boxplots</a>, <a rel="nofollow" href="https://www.r-bloggers.com/search/map" title="Maps and gis">maps</a>, <a rel="nofollow" href="https://www.r-bloggers.com/search/animation" title="Animation in R">animation</a>), programming (<a rel="nofollow" href="https://www.r-bloggers.com/search/RStudio" title="RStudio IDE for R">RStudio</a>, <a rel="nofollow" href="https://www.r-bloggers.com/search/sweave" title="Sweave and literate programming">Sweave</a>, <a rel="nofollow" href="https://www.r-bloggers.com/search/LaTeX" title="LaTeX in R">LaTeX</a>, <a rel="nofollow" href="https://www.r-bloggers.com/search/SQL" title="SQL and databases">SQL</a>, <a rel="nofollow" href="https://www.r-bloggers.com/search/eclipse" title="Eclipse IDE for R">Eclipse</a>, <a rel="nofollow" href="https://www.r-bloggers.com/search/git" title="git and github, Version Control System">git</a>, <a rel="nofollow" href="https://www.r-bloggers.com/search/hadoop" title="Large data in R using Hadoop">hadoop</a>, <a rel="nofollow" href="https://www.r-bloggers.com/search/Web+Scraping" title="Web Scraping of google, facebook, yahoo, twitter and more using R">Web Scraping</a>) statistics (<a rel="nofollow" href="https://www.r-bloggers.com/search/regression" title="Regressions and ANOVA analysis tutorials">regression</a>, <a rel="nofollow" href="https://www.r-bloggers.com/search/PCA" title="principal component analysis tutorial">PCA</a>, <a rel="nofollow" href="https://www.r-bloggers.com/search/time+series" title="Time series">time series</a>, <a rel="nofollow" href="https://www.r-bloggers.com/search/trading" title="finance trading">trading</a>) and more...
<img width="1" alt="" src="http://feeds.feedburner.com/~r/RBloggers/~4/PhZkLKitU1o" height="1"></a></div>