Sanguine Connections: Navigating the Complex World of Biospecimen Feasibility

May 29, 2024

Welcome to Sanguine Connections exploring the process, challenges, and nuances of biospecimen procurement for translational studies.

Navigating the Complex World of Biospecimen Feasibility

In this edition, we explore how a robust understanding of feasibility is essential to avoid stopping your research in its tracks.

What makes finding biospecimens complicated?

Biospecimens are critical to scientific and medical research. They serve as the foundation for many discoveries in genetics, disease mechanisms, and therapeutic developments. However, obtaining these valuable samples is fraught with challenges – everything from ensuring samples are ethically sourced, the logistical challenges of collection itself, and of course finding the biospecimens that fit the criteria for the study. In this blog, we focus on the third challenge – determining feasibility for finding the right biospecimens for your research.

There are several considerations in identifying the complexity of the needed biospecimens for a study.

1. Rarity of Condition

Not surprising, the prevalence of diagnosis directly correlates with ease of identifying donors. For example, in the United states, almost 25% of adults have been diagnosed with arthritis compared to 0.025% diagnosed with scleroderma. Finding donors diagnosed with scleroderma is feasible, but to ensure success, partnering with a biospecimen procurement company with an in-depth understanding of specific communities is essential. Your partner needs to be able to determine the feasibility of finding donors who meet the needs of the study. For example, myasthenia gravis (MG) is a rare disease and within the disease there are two types – AChR and MuSK which have different courses of action for treatment. Sanguine was able to provide serum from donors with a diagnosed subtype of MG along with healthy controls for a biomarker study by leveraging our extensive donor community. The project was further expanded to multiple recalls to monitor biomarkers over time.

Much of the understanding of feasibility at Sanguine comes from a direct-to-donor model as there is often already a community of donors with the condition of interest in our community of over 70,000. Further, there may be relationships with specific patient advocacy groups.

Learn more about the direct-to-donor model in this blog.

2. Inclusion and exclusion (I/E) criteria

Regardless of the rarity of the condition, the I/E criteria can narrow the target population significantly. For example, criteria can include specific age range, disease stage, genetic markers, or inclusion or exclusion of previous treatments. A study can have a complex combination to meet multiple criteria simultaneously thus further reducing the eligible pool of donors. Extensive knowledge of the medical history of a donor community can help determine the feasibility of specific I/E criteria. Electronic health records (EHR) provide a wealth of information that is easily searchable to quickly identify appropriate donors for a study. Brian Vong, who leads donor recruitment at Sanguine explains, “Complex study designs or research in rare patient populations can introduce risk that objectives may not be achievable, or that the required sample is not feasible. Through our extensive experience conducting EHR analysis and questionnaires with our donor community, we have developed an efficient approach to assessing the feasibility of study designs analyzing the percentage of patients that fits the study inclusion and exclusion criteria of a study.”

Learn more about EHR in this blog.

3. Geographic distribution

A larger geographical distribution of donors has several advantages for more robust studies. First, although there are studies that require a discrete population, often one seeks broad representation to ensure the findings can be generalized to a larger population. Thus, having a biospecimens collection concentrated in a specific metropolitan area may only provide a piece of the puzzle of understanding a specific condition.Building upon that, diverse biospecimens can help understand differences within a population based on geographic collection. Lastly, in the case of rare diseases and complex I/E criteria, having a broader region of collection can increase success in finding donors. There is, however, a balance with diverse geography and speed. Depending upon the downstream studies, there are times when samples need to be processed within hours of collections and thus a concentrated donor collection is necessary.

How do you evaluate if your biospecimen procurement company will deliver what you need?

As we have delved into some of the challenges in finding the right biospecimens for your research, the question becomes what is your level of confidence in the likelihood of success in your chosen biospecimen partner? At Sanguine we discuss our success as the rate of delivered to plan. This is calculated by taking all of the translational projects we initiated from 2021 to 2023 and calculating the percent of biospecimens that were delivered compared to the plan. This includes rare diseases and complex I/E criteria. The answer is 93%. We can get more granular too, such as we delivered over 97% lupus SLE projects, 96% rheumatoid arthritis, and 100% cystic fibrosis projects to plan. This confidence in fulfilling your project requirements is essential in keeping your research progress on track.