As you read this post over your afternoon coffee, scientists all over the world are hard at work trying to prevent the spread of deadly viruses, and cure and treat debilitating illnesses like cancer, HIV and Alzheimer’s. When a breakthrough happens and one of those scientists puts her finger on
Tag: Risk-Based Monitoring
Our own Richard Zink has written extensively about the risk-based monitoring (RBM) capabilities in JMP Clinical, both on this blog and, of course, in his book. As a complement to the wealth of hands-on information that Richard has created, which primarily covers the mechanics of RBM with JMP software, we
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
Richard Zink blogged about “7 things to love about JMP Clinical 5.0” the day that JMP Clinical 5.0 and JMP Genomics 7.0 were released. In his post, he highlighted seven important new or improved functions in JMP Clinical 5.0, including RBM (risk-based monitoring), fraud detection, SMQs (Standardised MedDRA Queries), predictive
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
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