Lots of people don’t understand what R2 is and why it’s needed. And unless you understand the fundamental reasons for its creation and adoption, it’s easy to dismiss it as ‘just more bureaucracy’. But it isn’t. It’s much more important than that, and here’s the reasons why.
The way clinical trials are conducted has changed dramatically over the last 20 years, resulting in ever more data being captured electronically.
But clinical systems and clinical trial monitoring practices have been mainly focused on checking quality at the point of data capture, and less focused on the study data set as a whole. That creates risks to both patient safety and data integrity.
Traditional trial management processes leave the overall trial ‘quality’ aspect to the end, and by then it’s often too late. This is evidenced from 45% of clinical trial submission failures being due to data quality and data integrity.
Quality needs to be built into the clinical process right from the start. In the traditional trial process however, only 2% of the data is ever changed as the result of the traditional SDV model.
The Regulatory authorities have seen this gap and have responded with new industry guidance – ICH E6 (R2) (commonly referred to as R2).
While the R2 guidance tells companies WHAT they need to do, it does not tell them HOW to do it. As a result, many companies find the process of adopting and operationalizing the new guidance a significant challenge.
That’s where TRI comes in. With our unique combination of tools (Risk Assessment, R2 Accelerator and Standard Operating Procedures (SOPs)), technology (OPRA – a Risk Based Monitoring platform that uses statistical modelling and data visualisation to identify risks early) and services (training, consultancy and support), we help companies identify and address quality issues from the start of a trial, become R2 compliant, and in the process, save money, improve data quality and improve patient safety. What’s not to love about that?
To find out more, please contact me today at Duncan.Hall@tritrials.com.