Tag: Clinical Trials

The 2013 JMP Life Sciences European Roadshow

This May, JMP Life Sciences is going on the road in Europe to demo some of the new features that will be available in the upcoming releases of JMP Clinical 4.1 and JMP Genomics 6.1. The Roadshow is an excellent opportunity to hear about new functionality, ask questions or perhaps sneak

Truly efficient clinical reviews – an example

JMP Clinical 4.1 contains example data to help illustrate its new review functionality. This additional data is referred to as Nicardipine Early Snapshot, and includes Nicardipine data only through 01 Aug 1989. There are numerous changes to this data set: 11 subjects have yet to enroll in the trial, the

Truly efficient clinical reviews – it’s all about the keys

In last week’s post, we discussed some of the upcoming features of JMP Clinical 4.1 that identify new and modified records when clinical trial data is updated. These tools can greatly accelerate clinical reviews, allowing the clinician, statistician or data manager to focus exclusively on unreviewed records. Here we discuss

Truly efficient data reviews for clinical trials

Over the next few posts, I discuss the data review process for clinical trials and highlight some new features for JMP Clinical 4.1 that streamline this monumental endeavor. Ideally, the data from a clinical trial should be examined by as many eyes as possible – including data and protocol managers,

Identifying multivariate inliers and outliers

We’re nearing the end of this series of posts on fraud detection in clinical trials and some upcoming features of JMP Clinical 4.1 that help identify unusual observations. We’ve described how visit dates and measurements taken in the clinic can signify problems at the clinical site, and discussed how trial

Clinical trial visit dates can signal something is amiss

Sometimes we’re so wrapped up in the day-to-day activities of conducting a clinical trial that we forget to perform some of the more obvious data checks. Data cleaning activities that seem unlikely to bear fruit because “I can’t believe they would do this” or “no way they could mess this up”

Locating potentially fraudulent data in SDTM Findings domains

We continue our discussion of unusual and potentially fraudulent data from clinical trials, and today we focus on data that occur in CDISC Findings domains. From the SDTM Implementation Guide, Findings domains represent data from planned evaluations that address specific tests or questions. For example, these domains contain data from

Identifying re-enrolled subjects in clinical trials

Over the next several blog posts, I will discuss various analyses that can be used to identify unusual and potentially fraudulent data from clinical trials. See Buyse at al. for a good summary of clinical trial fraud, including suggestions for statistical methods to help identify unusual data. JMP Clinical 4.1