In lxt3/fdatemplate: Distributes an rmarkdown Word template for FDA DBS review memos

# load packages
library(MASS)
require(knitr, quietly = TRUE)

# set global options for R chunks
opts_chunk$set(warning=FALSE, message=FALSE, echo=FALSE, cache=TRUE, cache.extra=list(R.version))

Background

This describes the background of the device, including regulatory history and device description.

Study Design

The study was a randomized, controlled, two-arm trial. Here are some other details about the study.

Primary Endpoints

The primary effectiveness endpoint was the subject's score on the Happiness Index.

Secondary Endpoints

The secondary endpoints were

• Endpoint 1
• Endpoint 2
• Endpoint 3

Study Results

Results showed that the device was not effective.

Statistical Issues

This section describes my issues with the sponsor's analyses..

Issue 1

Here is the first issue with the sponsor's analyses.

# Here is my analysis of the primary endpoint
# R code goes here.  The output will show up in the word document. 

Issue 2

Here is the second issue.

Deficiencies

1. Def 1
2. Def 2

Conclusions

In this paragraph, I describe my conclusions.

If you have questions about this review, please contact me.

Laura Thompson

lxt3/fdatemplate documentation built on May 7, 2019, 11:13 a.m.