Research is vital to innovating in the field of health and care, and clinical trials are at its core. However, participants can be difficult to recruit and inaccuracies in the data could lead to incorrect conclusions being drawn.
In Ireland, the integration of the nationwide Maternal and Newborn Clinical Management System (MN-CMS), not only gave midwives and mothers accurate information in real time and practically any location, it also presented the opportunity to benefit maternity studies by making it more efficient for expectant mothers to join clinical trials.
In April 2017, Cork University Maternity Hospital (CUMH) and University Hospital Kerry (UHK) went live with PowerTrials®, our clinical trials management solution, as part of MN-CMS.
It was immediately used for the IMPROvED study, a large-scale European research project, which aims to develop a predictive blood test for pre-eclampsia. Previously, research investigators spent five hours 45 minutes a week attending antenatal booking clinics to identify suitable first-time expectant mothers in early pregnancy.
However, as PowerTrials is integrated into the Cerner Millennium® electronic health record (EHR) – the platform upon which MN-CMS is built – pre-screening rules based on the study’s inclusion/exclusion criteria could be applied to existing patient data to find appropriate trial candidates. This allowed the IMPROvED team to reduce their weekly activity to two hours 30 minutes – a 67 percent reduction.*
The solution allowed clinicians to see open trials and whether their patient was applicable, while also allowing researchers to be proactive with recruitment and identify applicable potential subjects based on trial inclusion criteria, rather than relying from referrals. Subject management was supported too – a flag was added to the EHRs of people taking part in trials so other care providers could be aware of their involvement to help them make safer decisions at the point of care.
Elizabeth Tully, the programme manager of Perinatal Ireland, remarked: “The PowerTrials tool provides oversight and improves the quality of clinical research in the perinatal space by streamlining study design and trial governance, and developing a robust quality system around patient screening and recruitment, which greatly assists clinicians in accessing and engaging with the national perinatal research landscape.”
Pre-eclampsia is a complex disorder that requires a personalised medicine approach. The main goal of IMPROvED was to develop a clinically robust predictive blood test for pre-eclampsia, using innovative technologies and utilising novel metabolite and protein biomarkers. The IMPROvED study has screened 5,000 European women across five countries.
* Calculated by comparing a week-long manual time study at a single clinic prior to go-live, with a week-long manual time study at the same clinic after go-live.