Tag: Clinical Trials

Risk-based monitoring: Defining thresholds for risk

Now that we have put together a data set containing the important metrics to monitor safety and site performance, we need to define the thresholds that constitute elevated risk. Unfortunately, there is no one-size-fits all solution to this problem. The study population (e.g., pediatric, elderly or at particular risk of safety

Risk-based monitoring: Let's start with the data

To begin our discussions on risk-based monitoring (RBM), we first need to start with the data. The data include various metrics to assess site performance, and may include several key measures of safety such as deaths and adverse events (to assess safety concerns or under-reporting). But where to start? These

It’s time to "crossover" to JMP Clinical 4.1

My colleagues are often surprised to hear I went through five majors in college to find my niche in statistics. I started as a physical therapy major, which quickly turned to nuclear medicine, communications, psychology, and finally late in my junior year I became enamored with the beauty of statistics

Detecting drug-induced liver injury with JMP Clinical 4.1

In my previous post, I highlighted several of the new features in our latest JMP Clinical release for clinical findings analysis (with a little help from Dr. Seuss). I didn’t use one of my favorite quotes from Oh the Places You’ll Go; so just to get it out of my

Oh, the places you’ll go with findings data in JMP Clinical

A recent post by Richard Zink highlighted the Shift plots process in JMP Clinical software. Shift plots (and shift tables, a recent enhancement to JMP Clinical 4.1) are a key analysis for data from SDTM findings domains (e.g., laboratory, vital signs, etc.), according the FDA ICH E3 guidance. JMP Clinical

Understanding shift plots in JMP Clinical

JMP Clinical has several features to summarize records from SDTM Findings domains, data that result from “planned evaluations to address specific tests or questions.” In other words, this includes any data from the myriad of tests or procedures that are performed as part of the doctor’s examination: laboratory tests, ECG

JMP attends the PSI Conference in Edinburgh

I had the pleasure of interviewing Richard Zink, Principal Research Statistician Developer in the JMP Life Sciences division, prior to his visit to the UK to speak at the PSI (Statisticians in the Pharmaceutical Industry) Conference in Glasgow on 14 May. His PSI talk is titled "Assessing the Similarity of

Analyzing adverse events using Bayesian hierarchical models

You may be asking yourself… “Two Bayesian posts in a row? What is going on?” Though my statistical training focused on Frequentist methodologies, I am a big believer in using whatever tools help me gain insight into the statistical problem I happen to be focusing on at the moment. Frequentist