Nova Biomedical and C-TRIC
ANALYTICAL AND CLINICAL EVALUATION OF POCT GLUCOSE METERS:
C-TRIC has now worked with a range of global leaders in the clinical evaluation of many medical technologies including medical and diagnostic testing devices. One such leader is the United States diagnostic company, Nova Biomedical, which also has multiple manufacturing facilities across Europe. Nova Biomedical UK approached C-TRIC to request an analytical and clinical evaluation of a number of glucose monitors, in order to test their precision on the intended user population (patients with diabetes). Research involving human participants can only proceed with statutory Research Ethics Committee (REC) approval, and as this study involved patients from the Western Health and Social Care Trust (WHSCT), appropriate Research Governance approval was also sought. The applications for ethical review were prepared by C-TRIC, with input from a Clinical Consultant. In addition, all supplementary documentation required for the ethical application submission was prepared by C-TRIC, and approvals from both Ethics and Governance committees were granted within 12 weeks. The analytical precision testing commenced immediately, adhering strictly to the approved protocol. This involved collection and pooling of blood samples in C-TRIC, from healthy volunteers. Blood samples were then spiked with various known concentrations of glucose which were subsequently tested using the study glucose meters. As a reference method, Gold Standard HbA1c levels were provided by the Altnagelvin Hospital’s diagnostic biochemistry laboratory, which is conveniently located opposite C-TRIC. After the analytical phase of the study was completed, patient recruitment started for the clinical evaluation of a number of POCT glucose meters. This part of the research involved 125 patients with diabetes from the Diabetes Clinics at Western Trust. Patients who agreed to participate in the study attended appointments at C-TRIC, and the phlebotomist collected capillary blood samples. The blood samples were then taken to C-TRIC laboratories to determine glucose levels using both the hand held glucose meters and the gold standard YSI capillary blood glucose analyser. Both research studies were completed in 20 weeks. The results of these studies were presented by C-TRIC, on behalf of Nova Biomedical UK at the 24th International Symposium held in Prague, Czech Republic October 2012. C-TRIC has an excellent track record of patient recruitment and retention in clinical trials, boasting turnaround times that are surely a record within the UK’s highly regulated clinical study system. This has been possible due to the assembly of a strong team of professionals at C-TRIC that complement its unique infrastructure, as well as clinicians’ willingness to facilitate research by authorising access to patients from specific diseased populations.
LAY USABILITY STUDIES FOR MEDICAL DEVICES
All medical devices used by patients themselves must be assessed to ascertain if they are easy to use and that their instructions are easy to follow. C-TRIC has excellent facilities for focus groups and lay usability studies. The research team are highly organised and ensure that these events are run seamlessly. Convenient, free parking allows patients to arrive at C-TRIC stress free and it also helps sessions start on-time. Such studies involving patients must be reviewed by a statutory research ethics committee (REC), and approval must be granted before proceeding. C-TRIC is very experienced in this process and has been able to get approval within two weeks of starting the IRAS application, through proportionate review. Studies of this type can be completed within 7-12 weeks. Patients who have participated in focus group studies in the past have all expressed an interest to return and have remarked how much they enjoyed the whole experience.