Sanguine Connections: Shared Benefits of Our Direct-to-Donor Model

May 10, 2024

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

Shared Benefits of Our Direct-to-Donor Model

In this edition, we explore the benefits of the direct-to-donor model for acquiring samples both from the perspective of the researcher and the donor and how they intertwine.

What is the direct-to-donor model?

Sanguine was founded in 2010 with the mission of bridging the gap between researchers and the biospecimens they need through a donor community. One of the founders, Brian Neman, was inspired by a high school friend who was diagnosed with multiple sclerosis (MS) at the young age of 12. In high school she was a strong patient advocate from donating her own blood for research to starting a patient advocacy group called Youth Against MS. This group grew to 5,000 members across the US and demonstrated to Neman “the power of engagement and advocacy for the purposes of advancing research.” Neman along with co-founder Gerald Lee set out to lower the barrier for people to participate in research for conditions that ail them by donating much needed biospecimens, and thus created the direct-to-donor model. Neman describes how “if we decrease the burden, we will have a community of people wanting to participate, and we make it easy for them to do just that from obtaining their electronic health records to coming to their home for sample collection.” Ultimately, connecting the researchers with donor biospecimens is a necessary piece to accelerating discovery.

Benefits to the donor

For donors, this model allows them to actively participate in research aimed to find a treatment or cure for conditions they or loved ones suffer. Further, as many of our biospecimen collections are minimally invasive, collections with the exception of apheresis, take place in the donor’s home. One donor who at the time had signed up for her fifth study, described how “I actually have them [Sanguine] do all the work for me so I signed up once and they contact me every single time.” As a lupus advocate with a chronic illness, the donor was eager to get involved in research opportunities and appreciated that for the ones she qualified, Sanguine “walked me through it, they got my medical records, they even sent a phlebotomist to my house so it makes it easy for me.”

More than the biospecimen for researchers

The direct-to-donor model may have even more benefits for the researcher as the connection with the donor provides so much more than just the sample in a tube.

* Assurance of quality – Understanding exactly where the biospecimen came from, how it was acquired, and appropriately consented are essential for maintaining high ethical and quality standards. Thus donor recruitment, informed consent, and collection all being provided by a single trusted partner provides peace of mind.

* Data beyond the sample – A direct connection with the donor means the researcher can get more data about the donor. A researcher should expect donor demographics and confirmed diagnosed conditions, but also can have so much more information including donor-reported outcomes, electronic health records (EHR), and customized surveys. Additionally, the direct connection with a donor network allows one to perform longitudinal studies, as well as, recallability of donors.

Read how a robust and engaged donor network participated in a longitudinal study over several years aimed to monitor biomarkers in people infected with hepatitis B

* Commitment to success – Translational studies are complex, time consuming, and costly. Depending upon the rarity of disease, inclusion and exclusion (I/E) criteria, and other constraints, donor recruitment can be a barrier. A direct-to-donor connection means your procurement partner will have the level of knowledge and experience to determine feasibility and carry out recruitment for sample collection that allows you to plan appropriately. Looking at the prior success rate for a prospective partner gives you greater confidence in the likely success of your project. In other words, how often has a provider been able to deliver all planned collections adhering to the established criteria? For a reference, at Sanguine our delivered to plan rate is 93% – that includes all translational studies initiated including rare diseases and very complex I/E criteria.

A direct connection between your partner for biospecimen procurement and the donor can provide a wealth of information, speed, and peace of mind regarding the collection. A layer of transparency is removed that should allow real-time communication about your project, resulting in accelerating your discovery.