Considerations for Feasibility for Translational Research
For many researchers, considering the feasibility of a translational study with Sanguine Biosciences is a crucial yet challenging step. The proposed study they submit might not be possible based on real-world evidence or Sanguine’s service offerings, requiring them to modify their criteria. “What they submit as a request and what we land on and finalize can look completely different,” says Amanda Effres, Head of Feasibility and Study Design at Sanguine.
This disparity often stems from researchers relying on a traditional model that involves using physicians to recruit patients, as well as acquiring patient samples in hospitals. The services Sanguine provides, however, disrupt this model in order to streamline the clinical trial process, Effres explains. To ensure Sanguine can feasibly help them conduct their translational study, she recommends researchers consider their criteria for subjects, specimens, visits, processing, and patient accessibility, especially if the request requires a patient advocacy group.
The most important consideration is whether the subject criteria requested realistically reflects the patients available. Many researchers have a rigid patient profile that excludes first-line therapies and standard-of-care treatments. For instance, they may want to obtain samples only from patients experiencing autoimmune flareups who aren’t taking steroids. This typically isn’t feasible, though, since patients with autoimmune conditions often rely on steroids to treat the symptoms of their flareup.
Instead of excluding a whole class of medications, perhaps specify a few that are particularly important to exclude, or exclude a maximum dose. Likewise, consider the feasibility of excluding comorbidities. Although you may want to exclude autoimmune comorbidities, for example, this may not be possible, since such comorbidities are relatively common. Rather than excluding all comorbidities in a given therapeutic area, identify which ones are most important to exclude. “It’s about getting a bigger picture of the condition instead of honing in on [the researchers’] criteria and the stringent profile they’re looking for,” Effres says.
It’s also critical to define who qualifies as a healthy patient. Do you want to exclude all prescribed treatments, medical diagnoses, and current or previous use of tobacco products or recreational drugs? Do you want to limit the subject criteria to certain BMI ranges?
Next, consider the specimen requirements. Can the samples requested be safely collected in the home or other non-clinical private setting? Keep in mind that Sanguine can only obtain samples collected through minimally invasive methods, such as saliva, urine, buccal swabs, and whole blood via venipuncture or fingerstick. Also consider when you need to receive the samples. In some cases, Sanguine can deliver samples directly to researchers within four hours of collection.
Visit requirements are another key consideration to make in determining feasibility. Sanguine has found success going directly to patients and collecting samples from the comfort of their homes, “but it limits the requests we can fulfill,” Effres says. A procedure that requires an elaborate laboratory setup, for instance, or a phlebotomist to remain in a patient’s home for several hours, might be unrealistic. Remember that Sanguine can complete other visit activities beyond sampling, including vitals measurements and sample processing, although this is limited to centrifugation and aliquoting. Sanguine can also conduct questionnaires, depending on the questionnaire requirements and expertise needed to administer it.
Consider the study’s processing requirements, as well, and establish expectations for the timeframe between collection of the samples and processing with Sanguine’s capabilities in mind. Certain types of processing, such as serum or plasma isolation, can be performed in-home by a phlebotomist. Again, more complex processing that requires a lab facility may not be feasible for the home visits Sanguine conducts. That said, if you need same-day processing that requires a lab facility, Sanguine may be able to restrict recruitment to the areas around its existing labs to process and store samples within 12 hours of collection.
Last but not least, considering patient accessibility is crucial. The audience reach for the disease of interest needs to be large enough for Sanguine to effectively recruit patients through social media and search engine platforms. If there is no audience reach on these platforms, the study wouldn’t be feasible unless Sanguine has a partnership with a patient advocacy group (PAG) dedicated to the specific disease who could help with recruitment.
If your request requires a PAG, it’s important that Sanguine have permission to share specific details with the group and participants about the research purpose and intended use of the samples. Ideally, they would be allowed to know the name of the research company receiving the samples, as well. “More often than not, the likelihood of solidifying a partnership with a PAG is much higher if we’re able to share details about research groups,” Effres says.
Making these considerations for feasibility and being flexible with your criteria early on in the study design process can save time in the long run and contribute to smooth, efficient collaboration with Sanguine. “We really want to ensure that [researchers’] needs can be adapted to Sanguine’s service offerings and how we operate,” Effres says.
Sanguine has a robust community of more than 30,000 patients across several diseases, offers home visits nationwide, has completed more than 500 research studies, and provided samples and data for more than 100 peer-reviewed papers. This proven expertise in patient engagement and data collection, combined with a careful consideration of your study criteria, can significantly accelerate research for your condition of interest.
ABOUT THE AUTHOR:
Brian Neman serves as the Co-Founder and CEO of Sanguine Biosciences. Brian focuses on all items relating to commercialization and relationships with researchers; he is an adjunct professor of Digital Health at USC, and co-founded Sanguine in 2010 out of his graduate program in healthcare administration at USC. He is also on the boards and committees of various organizations including HD Care, BIOCOM Big Data Committee, and more.