Expert Insight: Prism on JMP® Clinical

Our team includes experienced statisticians, programmers and trainers from a range of backgrounds. One large but highly specialised area is clinical trials, and we are proud to be a certified JMP Clinical Trials Partner. This is only possible due to our exceptional consultants in this field, including Kate Tomlinson, Rob Davis and Katrina Gore. They’ve supported various clients who use JMP Clinical, a data analysis software package specifically designed for those working in this area – so we asked them for their thoughts on it!

The Prism team on... what JMP Clinical offers:

The software provides a suite of tools geared towards Centralised Statistical Monitoring (CSM), Risk-Based Monitoring (RBM), fraud detection, data monitoring and more.

It also provides automated patient profiles and narratives for Adverse Events (AEs).

The Prism team on... who should be using the software:

Anyone involved in clinical trials! Data managers, CSM and RBM teams, statisticians, medical writers and many others. It’s designed with the FDA’s requirements in mind, so is ideal for producing clinical submissions to regulatory agencies.

The Prism team on... which tools within JMP Clinical they find most useful:

On a recent RBM / fraud detection project, we routinely used the Multivariate Inliers/Outliers, Digit Preference and Duplicate Records tools, amongst others. The Multivariate Inliers/Outliers test helps to identify patients who are radically different from the rest of the population – or are suspiciously average! Digit Preference identifies inconsistencies in a site’s recorded results, detecting different levels of precision, mis-calibrated equipment or even the fact that results have been estimated rather than measured. Duplicate Records highlights cases where a patient’s records have been duplicated across visits or across patients. The clustering tools can be used to identify duplicate patients, who have enrolled at more than one site.

The analysis of every study produces findings of interest which would be difficult to detect either by eye or through the routine procedures involved in running and analysing a clinical trial. It is an essential tool for monitoring and improving the data quality of a clinical trial.

As well as the reports and analyses developed specifically for JMP Clinical, you also have access to JMP’s standard toolkit of visualisation and analysis tools – this makes it easy to drill down and explore the data in more detail when required.

The Prism team on... how they have helped new or existing JMP Clinical users:

We’ve performed analyses and reported back to the study teams, effectively providing an outsourced analysis service. However, we’re always very keen to provide enablement to the users within an organisation, reducing or removing their dependence on external groups. To do this, we work with the users as they analyse their own data, mentoring them on which tools to use and how to interpret the output. We've worked extensively with Roche in this type of support role; you can read more about this successful partnership here.

We also offer training courses to get people up and running with the software, as it can initially seem a daunting prospect to familiarise yourself with the many tools available!

We can also provide scripting support, to customise the software’s standard output to an organisation’s exact requirements – as well as automating routine workflows, to dramatically reduce the time required for each analysis. We can also perform – or advise on – data mapping to get a client’s data into the required CDISC format.