Risk-based monitoring (RBM) is a hot topic in the clinical trials arena. It’s a new way of designing and operating clinical trials. Now, rather than visiting each clinical trial site and reviewing all patient records, you identify just those who present the higher risk of poor data quality, fraud and
If you work or have worked within the pharmaceutical industry, then you are likely familiar with MedDRA, the Medical Dictionary for Regulatory Activities. This dictionary makes it possible for drug and device companies to perform analyses of adverse events or medical history. First, MedDRA provides a way to consistently map
New versions of JMP Clinical and Genomics are available starting today, so I wanted to take the opportunity to give a brief overview of some of the new features you’ll come to enjoy with the new release of JMP Clinical 5.0. Below are seven things to love! 1. Risk-Based Monitoring
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
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
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
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