Biospecimen Feasibility: Tips to Maximize Research

Welcome to Sanguine Connections, exploring the process, challenges, and nuances of biospecimen collection for translational studies, including the importance of ensuring biospecimen feasibility throughout the research.

 

 

Almost every significant breakthrough in medical science has leaned heavily on biological samples. These specimens—ranging from blood, tissue, and saliva, to cells and DNA—fuel studies across oncology, immunology, genetics, and drug development. Yet, beneath the surface of groundbreaking research lies an intricate challenge: securing the right specimens, in the right quantity, at the right time, which makes securing samples crucial.

Feasibility sits at the heart of every successful study, quietly determining whether ambitious research plans progress or fizzle out from a lack of samples. It requires thoughtful planning, trusted partnerships, and a strategic mindset from the earliest phases of any research project, emphasizing the need for assessments.

Let’s break down the key factors that make or break feasibility, and spotlight the practical steps researchers can take to give their projects the best possible odds of success.

Why Feasibility Demands Attention

Many don’t realize the sheer complexity involved in specimen collection and procurement until they run into delays. Why is feasibility such a linchpin? Consider these underappreciated elements:

• Defining exact donor characteristics – A project looking for blood from adults with lupus who have been untreated for at least a year and have no comorbidities already narrows the field from millions to just a handful of eligible candidates, highlighting the impact on biospecimen feasibility.
• Logistical and time constraints – Some specimens must arrive fresh, within hours, or be shipped cryogenically. Project timelines can derail if geography or infrastructure are overlooked, which can critically affect biospecimen feasibility.
• Budgeting and cost limitations – Rare biospecimens or complex collection protocols often escalate costs and time, requiring a clear assessment of feasibility early on to ensure biospecimen feasibility is maintained.

Stalling at any of these pinch points can mean missed deadlines, budget overruns, or, worst of all, abandoned research. A proactive, feasibility-first approach can spare researchers much frustration.

Key Variables in Securing Specimens

Effective feasibility measures start with understanding the variables that drive supply-and-demand in this space. Here’s a closer look:

1. Rarity of the Target Condition

Perhaps the most visible hurdle is the prevalence of the condition under study. The rarer the diagnosis, the harder it becomes to source high-quality, well-characterized samples, complicating sample acquisition. Here is a breakdown of just a few of the over 125 conditions Sanguine covers with our robust Donor Network:

Condition	Prevalence in U.S. Adults	Sample Accessibility
Arthritis	~25%	High
Scleroderma	0.025%	Very Low
Cystic Fibrosis	0.04%	Low
Myasthenia Gravis (MG)	~0.02%	Very Low; Subtyping needed

Even within a single diagnosis like MG, clinically relevant subtypes (such as AChR vs MuSK antibody positive) add another layer of complexity. A good biospecimen procurement partner does more than match diagnoses—they seek and build connections within relevant medical and patient communities, engaging advocacy groups and leveraging direct-to-donor networks to locate elusive donors, thus enhancing biospecimen feasibility. For example this study came to fruition in part due to a partnership with Fabry Support & Information Group for the much needed biospecimens.

2. Complexity of Inclusion and Exclusion Criteria

Every criterion applied to a potential pool of donors whittles down the eligible group, impacting sample acquisition. Age, disease stage, medication history, genetic variants—all can make a study population vanishingly small.

Modern tools, especially comprehensive electronic health records (EHR), allow for rapid screening and identification of potential donors. Large, well-maintained databases are especially valuable when the project asks for multiple, overlapping I/E criteria. Consultation with teams experienced in this sort of focus—leading EHR analyses, deploying targeted questionnaires, and running pre-feasibility checks—can be the difference between feasible and impossible study designs in terms of sample acquisition.

Get a snapshot of just some of the donor we have with our Donor Snapshots for Atopic Dermatitis and Systemic Lupus Erythematosus (SLE).

3. Geographic Diversity

Ideally, specimens would come from a wide cross-section of the population, improving the study’s robustness and generalizability. However, broader reach usually means higher logistical challenges, especially when it comes to specimen collection logistics, which affects sample acquisition.

Important nuances to consider:

• Broad reach: Offers greater demographic and clinical diversity; best for studies seeking to generalize results, enhancing biospecimen feasibility.
• Local concentration: Useful for time-sensitive specimens, special handling needs, or when processing must occur rapidly, which can sometimes limit biospecimen feasibility.

Each collection model requires trade-offs between sample freshness, representativeness, and cost, all of which can impact biospecimen feasibility.

4. Scale and Community Relationships

The size of the existing donor community can’t be overstated as a predictor of feasibility. Groups active in direct-to-donor engagement, with access to tens of thousands of willing participants and relationships with advocacy networks, are better positioned to respond rapidly to new requests—even in hard-to-reach patient populations, significantly affecting sample acquisition.

Strategies to Maximize Feasibility

Experienced research organizations and procurement specialists use several proven tactics to tilt the odds in favor of sample acquisition. Here’s a list of some widely adopted best practices:

• Early, realistic feasibility assessments – Involving procurement teams at the study design stage pays dividends. Objective feedback on target populations, I/E criteria, and collection challenges enables more workable study protocols that enhance biospecimen feasibility.
• Harnessing technology for donor identification – AI-powered EHR review and large-scale data mining allow rapid screening for eligible donors, mapping the actual size of target groups before recruitment begins, thus supporting biospecimen feasibility initiatives.
• Community engagement and advocacy partnerships – Building long-term relationships with donor communities and support organizations increases trust and response rates, especially with rare diseases, thereby improving biospecimen feasibility.
• Multiple recall capability – Securing donors for longitudinal or repeated sampling makes it possible to track biomarkers or disease progression—turning feasibility from a single event into a process that emphasizes biospecimen feasibility.
• Transparent communication and progress tracking – Maintaining open lines with both donors and researchers, plus clear milestones to track delivery rather than just intent, helps everyone stay on course for achieving biospecimen feasibility.

Selecting the right procurement partner determines more than just how quickly samples arrive—it can shape the trajectory of a whole research initiative. Before signing on, it’s smart to press for details and metrics regarding their approach to sample acquisition.

Assess partners on these critical dimensions:

• Track record and delivery rates – Ask for historic delivery data. How consistently have they met project goals for rare disease specimens or studies with complex criteria? The best organizations can offer specific statistics by indication, providing insight into their efficacy in ensuring biospecimen feasibility.
• Depth and accessibility of donor communities – Do they maintain a sizable, active pool of pre-screened donors? What’s their reach across geographies, disease types, and demographics, in relation to biospecimen feasibility?
• Breadth of services – From consenting, biospecimen collection, and sample processing, to shipment logistics—can your partner handle every stage without delay or confusion, ensuring biospecimen feasibility?
• Ethical and regulatory compliance – Look for clear, documented processes for informed consent, IRB approvals, and data privacy, which are crucial for operations.
• Flexibility for unique requests – How equipped are they to manage projects that require recall, special timing, or immediate processing needs? This flexibility is essential for biospecimen feasibility.

Evaluation Criterion	Key Questions to Ask Partner
Delivery rate (“to plan”)	What percentage of projects succeed, by indication, particularly in terms of biospecimen feasibility?
Donor network depth	How many active, pre-screened donors are available to support biospecimen feasibility?
Rare/complex criteria	Examples of similar projects completed successfully, especially relevant to biospecimen feasibility?
Collection model flexibility	Can they run both decentralized and local collection to enhance biospecimen feasibility?
Community engagement	How do they recruit and retain rare-diagnosis donors, impacting biospecimen feasibility?

Collaborating with partners transparent about their success rates and limitations helps set realistic expectations and reduces downstream surprises related to biospecimen feasibility.

Pitfalls to Avoid

Even the sharpest researchers can run into feasibility snags by underestimating the demands of biospecimen procurement, including the complexities of biospecimen collection. Common missteps include:

• Overly strict I/E criteria with limited population size
• Insufficient consideration for logistical realities (e.g., rural donors, time-sensitive samples)
• Ignoring the value of direct, ongoing communication with the procurement partner
• Delayed feasibility assessment, only after protocol approval

It pays to validate assumptions about donor availability and project practicality early and often for effective biospecimen feasibility.

Even the sharpest researchers can run into feasibility snags by underestimating the demands of sample procurement, including the complexities of specimen collection. Common missteps include:

One recent shift in specimen collection has been the rise of direct-to-donor models. Unlike traditional models, which rely heavily on clinical site recruitment, these new approaches maintain active, ongoing relationships with large communities of patient and healthy volunteers willing to participate in research, enhancing sample acquisition.

Benefits include:

• Higher responsiveness: Researchers can access more diverse and robust groups of donors on short notice, greatly aiding biospecimen feasibility.
• Greater retention for recall protocols: Direct connections foster trust, making it easier to recontact participants for follow-up or longitudinal studies, thus supporting biospecimen feasibility.
• Broader reach into rare disease communities: By partnering directly with advocacy groups and individuals, recruitment possibilities multiply, sidestepping the bottlenecks of single-center trials, which can significantly improve biospecimen feasibility.

Success in medical research is as dependent on reliable sample procurement as it is on innovative science. A thoughtful, methodical approach to feasibility—grounded in technical know-how, thorough planning, and strategic partnerships—acts as the quiet engine that keeps research moving forward, underscoring the importance of sample acquisition.

Success in medical research is as dependent on reliable biospecimen procurement as it is on innovative science. A thoughtful, methodical approach to feasibility—grounded in technical know-how, thorough planning, and strategic partnerships—acts as the quiet engine that keeps research moving forward, underscoring the importance of biospecimen feasibility.

Assess your project’s needs with honesty and gather information early. Insist on clarity, accountability, and transparent progress metrics from any procurement partner. Above all, embrace models that value flexibility, proactive communication, and deep engagement with donor communities to maximize biospecimen feasibility.

Brilliant research concepts deserve biospecimen strategies that rise to meet their ambitions.

 Contact us to learn more about the delivered to plan rate for conditions of interest, specifically focusing on biospecimen feasibility.

 

Learn more about the Sanguine Difference in biospecimen feasibility strategies.