We’ve talked about the data. We’ve defined our thresholds for risk. Now it’s time to talk about how you can visualize the safety and quality signals from your ongoing clinical trials. If you want to minimize the impact of quality issues to the data or quickly address any safety concerns
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
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
There is a lot of interest in risk-based monitoring (RBM) of clinical trials, and it’s easy to understand why. Monitoring activities can account for 25-30% of the cost of a clinical trial, so any efficiencies to be gained can come at substantial savings for the trial sponsor. ICH Guideline E6
In a recent blog post, I listed all of the updates to the Help system for JMP Clinical 4.1 and JMP Genomics 6.1. The Documentation team has worked hard to put all of the information you need to do your analyses right at your fingertips. Just click on the Process
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
As a former student and high school teacher and a parent of school age children, I always appreciated the “lazy days” of summer. They are a welcome break from homework, getting up early, studying for tests, traveling to away games, helping with homework and all of the other “normal” things
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
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
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