The key challenges
Logistical
The clinical trial included 14 sites in the US and Germany, and required an accurate and reliable method to screen LDL-C values. Woodley Trial Solutions has extensive experience in supplying equipment to both lab-based and point-of-care testing (POCT) for clinical trials in over 150 countries worldwide. The team handled all the logistics for the trial, and supplied a custom device – developed in partnership with the manufacturer exclusively for this trial – to rapidly evaluate LDL-C values. Staff on every trial site received hands-on, certified training to ensure they felt comfortable with how to use the device, and benefitted from ongoing technical support, enabling all doctors and nurses to quickly troubleshoot any issues and focus on their patients.
Technical
All patients were screened during their first visit to determine baseline LDL-C levels, which were then used to decide whether lipid apheresis was required in subsequent visits. Results were needed quickly for the safety of the patient, and to ensure lipid apheresis was only administered in patients needing the expensive procedure. Therefore, POCT was chosen over processing in central labs to speed up time-to-results and remove inconsistencies between each trial site.
A bespoke device was modified from an existing lipid panel that showed other parameters, including total cholesterol, high-density lipoprotein cholesterol and triglycerides. As only LDL-C values were of interest to the medical team, the software was edited to omit the superfluous information. The results of each blood test were displayed as six-digit codes to ensure that neither the patient nor medical personnel knew the actual values. They were then sent to a third party for decryption, which determined whether there was an increase of 10 per cent or more from baseline observations, allowing rapid reporting of a simple ‘yes’ or ‘no’ answer determine whether lipid apheresis should be administered.
Summary
Woodley Trial Solutions streamlined the clinical trial process to evaluate the effect of alirocumab on LDL-C levels in patients with HeFH, helping to determine whether this new treatment could reduce the frequency of lipid apheresis in these patients. Using POCT for screening and ongoing monitoring provided rapid, accurate and consistent results, with encryption further improving the robustness of the trial. The deployment of innovative POCT technologies like this requires not only technical knowledge and supply chain efficiencies, but also vast regulatory know-how to be able to implement these time-saving solutions to trial sites across the world.
