Blinded Diagnostics is selected for numerous Clinical Trials alongside our CRO partners to improve Study outcomes for Sponsors. Here are a few examples of trials which highlight some of the benefits Blinded Diagnostics can bring to your Study:
Encrypted POCT for Endpoint Measurement in a Large Coagulation Study
An event-driven, Phase 3, multi-national, multi-center, randomized, double-blind, double-dummy, parallel-group study in subjects with documented Atrial Fibrillation (AF). There are approximately 1,400 sites and 20,500 subjects worldwide.
As this study is blinded and INR results are the integral test parameter, the Sponsor needed a solution to perform blinded INR tests. Two blinded INR measurement options were identified during the Sponsor’s due diligence one used 5 regional laboratories whilst the other option proposed by Blinded Diagnostics used a single Point Of Care Testing device at each site.
POCT Results (5-10 minutes) on Same Day of Patient Visit allowed investigators to make dose adjustments without delay and sped up study completion.
Increased Enrollment Efficiency With POCT
In this Phase III study, by using a novel two-test criterion as a pre-screen with POCT, a significant number of prospective subjects were ruled out of the higher-cost screening period during the first enrolment visit.
The novel use of POCT for pre-screening at investigator sites provides a practical step forward shortening enrolment time and reducing the cost of more expensive CL screening tests.
For more information see the published article in Applied Clinical Trials online.
Infection Disease Study with Same Day Test Result and Specimen Prep
This Clinical Trial was conducted in 65 medical centers in 8 countries utilizing a POCT PCR Test to confirm the infection prior to enrolment.
Blinded Diagnostics trained and supported each site on use of the test device as well as providing detailed specimen collection and preparation for follow up analysis during treatment.
Lipid Drug Study with Blinded (encrypted) POCT to measure LDL
This Phase II Clinical Trial was conducted in using an encrypted Point of Care device to measure the LDL enrolled patients.
An approved POCT Lipid testing device was encrypted to report coded LDL test results. This device used a small blood sample taken by fingerstick. The ease of use of the reporting system combined with the rapid decryption of the result leads to increased operator satisfaction which contributes to a successful completion of the Clinical Trial.
POC Solution for Methemoglobin Safety Monitoring
Subject safety management required methemoglobin testing at multiple time points in study (measurement of IP effects on RBC).
Methemeglobin is only stable for 3 days, wIth 13 Investigator sites in Russia, transit times could not guarantee that samples would be tested within 3 days of collection and using multiple labs proved problematic. Two device options were identified with the Study Sponsor selecting a non-invasive POC solution that also reduced the blood volumes required.
An additional benefit of utilizing a POC device was that the standardization of testing meant that the data could be compared globally.