Description
Health care providers, who make decisions about patient care based on data from large-scale international clinical trials which utilise results from local laboratories, may not appreciate the lack of commutability of patient results between different trial sites, particularly in the case of less common or orphan assays. In this Scientific and Regulatory Affairs Committee symposium, the Bile Acid and Comparison and Harmonization (BACH) study protocol and project is updated and preliminary findings from the Australian arm are presented. The BACH project has the aim of reducing between-laboratory heterogeneity in total bile acid measurements as a sub-study within the international randomised controlled Trial of two treatments, URsodeoxycholic acid and RIFampicin, for women with severe early onset Intrahepatic Cholestasis of pregnancy, the TURRIFIC study.Methodological variations in measurements of total bile acids exist, reflected both in the performance of external quality assurance programs and subsequently in patient results. As a first step, the BACH project simulated the feasibility of mathematical recalibration using performance data from external quality assurance programs. From these simulations, mathematical recalibration has been shown to reduce between-laboratory variability in results. Additionally, power calculations for the necessary sample size to achieve harmonisation demonstrate operationally manageable numbers. Sixty comparison samples have therefore been manufactured, using pooled remainder samples from bile acid measurements, and laboratories have been recruited into the study from pathology networks providing clinical services to TURRIFIC trial sites. To date, samples have been distributed to, and analysis commenced at, nine participating laboratories for the Australian arm of the project. In respect of the European arm, delays due to the pandemic have meant that samples are expected to be dispatched in September with a view to analysis commencing in October.
| Period | 4 Sept 2021 |
|---|---|
| Event title | AACB 58th Annual Scientific Conference |
| Event type | Conference |
| Location | Virtual (rescheduled from Brisbane), AustraliaShow on map |