Overview
Accrual of representative patient populations to cancer clinical trials is an ongoing challenge, given the fact that many studies are only conducted at specialized research centers and the data collection burden is significant for sites. Alignment of study design with routine clinical care, implementation of technology to support patient identification, and application of centralized data curation can enable clinical studies to be conducted in routine care settings. This community-based study established a biobank with clinical annotation of patients with metastatic lung cancer to enable exploration of circulating tumor DNA as a potential biomarker and aimed to understand the feasibility of representative patient accrual in the community setting.
This researchers demonstrated the feasibility of conducting a pragmatically-designed, low intervention study in the community setting with ctDNA obtained at pre-specified time points. Overall 944 patients with advanced lung cancer enrolled across 23 US sites over 12 months, representing 24% of eligible patients. Flatiron Health Research Network sites utilized an EHR-integrated software platform to assist in patient identification and to curate high-quality information routinely collected during clinical care in a central study database, eliminating manual entry by sites in an electronic data capture system. The data and biospecimens obtained in this study have been subsequently used to explore the value of ctDNA in monitoring the progress of patients with advanced lung cancer.
Why this matters
As accrual goals in oncology trials remain an ongoing challenge, the pragmatic design and centralized operation of this study could be applied for more efficient, lower-burden, and lower-cost clinical trial recruitment in a variety of clinical trial contexts. By demonstrating that a pragmatic, technology-driven approach can successfully build a high-quality clinico-genomic database, this research paves the way for more efficient and scalable real-world data collection for clinical trials.