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Fit-for-Purpose Biospecimen Solutions: Scalable Considerations to Avoid Clinical Research Pitfalls

Clinical research would not be possible without the participation of patients who donate biological specimens (biospecimens) that help to confirm specific biological changes (i.e., biomarkers) that result from a clinical investigation. Guidelines for the collection of human biospecimens, originally developed by a committee appointed by the National Institute of Health (NIH), outline procedures and best practices for how biospecimens should be handled and stored to ensure proper stewardship.

When the proper specimen tracking systems are in place, such as warnings and transfer notifications, clinical trial sponsors ensure a greater oversight on the status and viability of biospecimens that become essential for the overall understanding and impact of their treatments. Although technology has improved the traceability and management of biological specimens, these systems still require management, especially during unexpected operational disruption or complex developments due to study design amendments or logistical situations such as global expansion.

In this article, we will review fit-for-purpose oversight and tracking solutions and key challenges any sponsor will most likely encounter and provide suggestions to address and mitigate risk regardless of company size.

Fit-For-Purpose Biospecimen Oversight Process Recommendations for All-Sized Companies

Regardless of the biomarkers selected for clinical research – the characteristics that are objectively measured and evaluated as an indicator of normal biological processes, or pharmacologic responses to a therapeutic intervention – there are key steps that must be established to take full advantage of the samples and data collected throughout the trial to ensure viable treatments and selections.

Regardless of company size, here are our suggestions:

Four Key Challenges and Suggestions for Biospecimen Tracking and Analysis That You’ll Likely Encounter

1. Handling Program Expansion

We’ve observed that program expansion (i.e., multiple studies) and global investigational presence exponentially complicates the oversight and sample management process. However, the greater the selectivity of the assay – a process of analyzing a substance to determine its composition and quality – and inherent simplicity of the biomarker procedures used, the more there will be adaptability to other sites and new laboratory facilities. Biomarker assays should also involve minimally invasive techniques, be simple to perform, and provide rapid and consistent results at a low cost.

Biomarker assessments of specific biomarkers can be driven based on literature and previous data of product programs. However, broader development of biomarkers may be necessary due to the limited clinical data or surrogate markers for a particular disorder.

2. Managing Protocol Amendments

Frequent amendments to clinical trials are common and they can have a domino effect on other assessments in the trial, such as managing biospecimen collection and tracking. Because advanced therapy trials can lead to additional specimens collected, here are a few best practices to help manage the changes:

Early collaboration between sponsors and central lab partners is increasingly important especially in advanced therapy studies. Central labs need to support study complexity and globalization demands of advanced therapy trials by providing solutions that adapt to study needs as they arise. As we all know that issues can arise throughout any point of the sample management lifecycle, the key is having the ability to act quickly and proactively to ensure swift resolution with minimal impact to the trial.

3. Managing and Monitoring Shelf Life

Managing shelf life is also a challenge, so establishing a good identification process for all samples is essential to managing sample shelf-life, baseline and post assessments, study number, and other key medidata that helps with selection of processing or destruction. As clinical programs begin to evolve, storage and management of specimens becomes more complicated, requiring medidata tracking, and sample reconsideration of initially selected biomarkers as more clinical data becomes available. 

4. Working with Scalable Financial Resources

Managing financial contracts can become increasing difficult as projects change and expand. Knowing the costs per sample can help improve your budget especially if samples can be systemically removed (if not viable), group shipped, and maximally grouped for analyses. Although management and tracking of biomarker samples can be aligned with established clinical and analytical reporting systems, continual oversight activities can be put in place to ensure only the viable and appropriate samples are analyzed.   


Ultimately, planning to use biomarkers in clinical research requires careful consideration of basic sample processing, sample management, storage, viability, storage, and analysis. However, initial plans should also include programs for growth and expansion. Sample analyses should be assessed early to ensure any expansion can be accommodated and managed cost effectively. Regardless of company size and program size, there are opportunities available and successful approaches to ensure successful clinical trial data management through a thoughtful biospecimen process.

If you would like to discuss this further, please be in contact.