Clinical trials and their supporting biomarker plans and assays have become increasingly complex. In the field of genomics, ctDNA liquid biopsy assays are particularly valuable for predicting response. These liquid biopsy results play an important role in advancing early phase clinical trials by retaining subjects on study who show a molecular response prior to response via RECIST 1.1 assessment. Sample collection, shipping, and timely analysis on validated platforms are critical aspects of the process and present challenges like sample stability, transport logistics, and regional assay readiness for accelerated measurements. These challenges are even greater in global studies due to local regulations, customs, and specialty lab availability. A Functional Service Provider (FSP) model can strategically address these issues by supporting study setup, analytical validation, sample management, and specialty lab oversight. This approach helps mitigate potential study challenges and accelerates early phase trials.
Learning Objectives:
Define what ctDNA liquid biopsies are and the relevance of this testing to early phase clinical trials.
Explore the challenges in testing presented by sample stability, transport logistics, and regional assay readiness, and how they are compounded in global studies.
Understand how an FSP model addresses common challenges in global ctDNA liquid biopsy testing to enhance early phase clinical trials.
