Biomarker-driven strategies are known to increase the likelihood of drug approvals but optimizing their integration into clinical research poses several challenges
This article outlines strategies and considerations used by Precision for Medicine staff to develop and execute biomarker-driven clinical trials. These approaches were created by our field operation professionals who support complex oncology biomarker-driven trials as well as our teams supporting other indications with cell and gene therapy studies.
Bridging the gap from pre-clinical to clinical isn’t always straightforward. To optimize success in biomarker studies, researchers should be prepared with the following:
A common obstacle sponsors face is the continued tweaking of planned biomarkers during early phase research. Refining biomarker selection is indeed a process, but it is critical to lockdown biomarkers at study start. When sponsors begin patient recruitment before biomarker identification and finalization, patient totals increase, scope expands, and budgets creep. However, those overages can be avoided by having a clear strategy and a solid protocol in place. The extra few weeks or months in the upfront can save sponsors from significant spend on the back end.
Our experience shows that trial operations, from patient identification to site selection and study timelines, are improved by setting up a pre-screening trial. This extra step can help funnel the right patients into suitable studies within their biomarker or immunotherapy pipelines. These can be established for Sponsors with sufficient pipelines focused on biomarker research in oncology indications, as an example.
Harmonized NGS testing standards do not yet exist. The testing done at an academic institution, for example, will differ dramatically from that done by a community-based hospital system where it may not be routine. The same apples for testing performed in large hospitals in the city versus a rural suburb.
To combat these issues, we look for ways to standardize the testing at each study site:
Ask about testing capabilities and approach when evaluating site feasibility.
Account for more screening failures than for a non-biomarker trial.
Select laboratory partners who meet your study’s needs.
Ensure the capabilities of your CRO match requirements.
Biomarker-driven trials are data-heavy. They involve more external data sources than non-biomarker trails and might rely on additional technologies to support data mapping and integration.
Scaling effectively requires a robust data management solution. Precision’s multiomic QuartzBio® data platform, for example, synthesizes diverse biological data to reveal hidden insights—within and across studies.
A well-designed logistics plan is integral to protecting the integrity of each precious sample. Assigning a dedicated logistics coordinator to serve as the single point of contact for CRAs, labs, and manufacturing vendors helps to mitigate the additional demands of biomarker research.
Logistic coordinators can also work alongside a virtual sample inventory management (vSIM) solution, to gain more centralized visibility into sample collection, processing, and storage status across siloed source systems.
Individualized treatment using biomarkers is a cornerstone of precision medicine. By partnering with an experienced biomarker CRO, you more confidently navigate the challenges associated with selecting and integrating biomarkers. We are ready to help you execute your next biomarker-driven clinical trial.
Tiziana Magnani is a Senior Project Manager at Precision in Milan, Italy. She has dedicated more than 20 years to project management and clinical research in different settings and brings more than 15 years of experience in the academic world and in the management of large multi-professional teams to Precision.
Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
