Like tailor-made suits, study designs can vary from project to project. So, why use a one-size-fits-all approach to obtaining patient samples?
Over the past 15 years, use of biobanks, and the off-the-shelf biospecimens and data they provide, has grown. However, the challenges facing this legacy model are becoming ever-more apparent.
Biobanks’ approach to collecting, storing, and distributing samples have, for example, raised ethical questions and concerns for these institutions’ long-term sustainability. One particular deficit — the lack of direct contact with patients — severely constrains biobanks’ ability to fulfill the unique demands of many study designs.
Because they obtain samples indirectly, through transactions with third parties, biobanks’ resources offer only a limited glimpse into disease biology and a patient’s health. Attempts to follow a patient over time or collect additional samples, for example, are out of the question.
Fortunately, the pharmaceutical industry has another option: direct patient access. By sending staff into patients’ homes, this model provides a number of concrete benefits that strengthen research in a wide range of therapeutic areas.
A larger, more diverse pool of participants
Conventional sample collection places the travel burden squarely on the shoulders of participants, with problematic implications for research. For instance, patients often cite geographic distance as a reason they don’t participate in clinical trials.
A direct access model can reach patients regardless of location, first by connecting with them through virtual recruitment campaigns. Mobile sample collection then relieves patients’ travel burden and allows them to participate at their convenience. By eliminating logistical barriers, it becomes possible to reach patients who may, for example, live in rural areas or have limited access to transportation, meaning a potentially larger and more diverse pool of participants — and ultimately, more robust results.
The power of timing
While samples obtained from a biobank may well have been collected much earlier, under circumstances unrelated to your study, a direct-access approach makes prospective collection possible. As a result, you obtain biospecimens and data that fit the needs of your study, rather than having to adapt your study to meet the resources available. Options that are out of the question for the indirect model, such as collecting multiple samples simultaneously or timing collection to an event, become available.
The benefits are both immediate and long-term. Rather than sitting indefinitely in a freezer, biospecimens can ship the same day they are collected, and researchers have the option of returning to the same patients to, for instance, gather additional information or conduct a longitudinal study.
A new dimension to data
Through an IRB-approved, HIPAA-compliant process, the direct model offers a wealth of patient-oriented data that simply isn’t available through a biobank. Access to electronic medical record data, for instance, makes it possible to verify patient status. What’s more, patients themselves become a source of information, through patient reported outcomes (PROs) and data from surveys, questionnaires, wearable technology, and long-term follow-up.
Relationships that benefit research
Perhaps most importantly, a direct access approach means specimens are much more than anonymous vials or data fields. This model relies on relationships, both with individuals and advocacy organizations, which become the foundation for extensive communities united by a desire to advance research through participation.
Once recruited, patients are typically highly engaged and interact frequently with mobile staff. These interactions give our staff the opportunity to establish the trust necessary to collect the diverse sample types needed to obtain a panoramic view of disease, and to follow its course over time.
Treating sample collection as merely a transaction limits its utility for research. Because we interact directly with patients, Sanguine can tailor data and biospecimen collection to best fit the needs of a specific study. Meanwhile, by advancing vital studies, we seek to help researchers give back to the patients who participate.
 Coppola L, et al. Biobanking in health care: evolution and future directions. Journal of Translational Medicine. May 22, 2019, https://translational-medicine.biomedcentral.com/track/pdf/10.1186/s12967-019-1922-3.pdf
 Ashcroft JW, Macpherson CC. The complex ethical landscape of biobanking. The Lancet. June 01, 2019, https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(19)30081-7/fulltext
 Chalmers D, et al. Has the biobank bubble burst? Withstanding the challenges for sustainable biobanking in the digital era. BMC Medical Ethics. July 12, 2016, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4941036/
 Chaudhari N, et al. Recruitment and retention of the participants in clinical trials: Challenges and solutions. Perspectives in Clinical Research. May 6, 2020, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7342338/