Dr Bertossi on the Role of Centralized Academic Reference Diagnostics and Biobanking in Clinical Trials

Consuelo Bertossi, MD, assistant doctor, Division of CLL, Department of Internal Medicine III, Universitätsklinikum Ulm, discusses the critical role of centralized academic reference diagnostics and biobanking in the context of prospective, multicenter clinical trials.

Bertossi notes that the integration of a single academic diagnostic facility in prospective, multicenter clinical trials ensures consistency, accuracy, and standardization of genetic analyses across different study sites, which is pivotal for obtaining reliable and reproducible results. In her presentation on TP53 mutations and their prognostic impact on chronic lymphocytic leukemia, which she gave at the 2024 EHA Congress, Bertossi highlighted that the success of the genetic analysis conducted in this study was largely due to its centralized approach.

By having all genetic analyses performed within a single academic institution, the research team maintained rigorous control over data quality and accuracy, Bertossi says. This centralized control allowed for the standardization of diagnostic assessments, which is crucial in multcenter trials where variability in data handling and analysis could otherwise compromise the integrity of the study’s findings.

Bertossi underscores that the use of a centralized academic diagnostic facility allows for high-quality data collection and enhances the credibility of the study outcomes. This is particularly important in trials involving complex genetic analyses, where the potential for error is high if conducted across multiple, non-standardized settings.

Moreover, Bertossi stresses the importance of biobanking in these settings. The ability to store and access biological samples in a standardized manner allows for retrospective analyses and the potential discovery of novel biomarkers, further contributing to the advancement of personalized medicine, according to Bertossi.

Bertossi concludes by advocating for the continued use of centralized academic diagnostics and biobanking in prospective clinical trials. She believes this approach is essential for ensuring the accuracy, reliability, and standardization of data, ultimately leading to more robust and meaningful clinical trial findings that can effectively inform patient care and therapeutic development.