Understanding the hurdles of biomarker integration and optimization
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 clear study concept, with the planned biomarkers defined
- An awareness of NGS and IHC testing standards per country and study site
- A plan to integrate study data effectively to best support decision-making
- An action plan for addressing the logistical aspects of sample management
I. Clear Study Concept and Defined Biomarkers
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.
II. Awareness of Testing Standards and Capabilities
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.
- Understanding NGS standards is key to a rapid study start-up.
Account for more screening failures than for a non-biomarker trial.
- NGS testing is an expensive part of screening, and the cost of screening failures must be factored into the budget.
Select laboratory partners who meet your study’s needs.
- Vet laboratories for the required NGS testing experience and the necessary capabilities to manage sample collection, shipment, analysis, etc. Learn more about Precision’s laboratory services.
Ensure the capabilities of your CRO match requirements.
- Often, biomarker studies require assay or companion diagnostic development. Verify that your selected partner has the capability to support its development, along with your study’s supplemental and downstream needs.
III. Study Data Integration and Application
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.
IV. Logistics of Managing Samples
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.
Key Considerations for Biomarker-Driven Clinical Trials
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.
