While the bulk of biospecimen-driven research takes place after the blood, tissue, or DNA samples have been collected, one of the most pressing challenges facing the biomedical research industry may be procuring human biospecimens in the first place. For clinical trials in particular, that often rely on consented patients to donate specimens for research, there can be crippling delays in finding and consenting the right patients and procuring the right specimens. Often after several months, sponsors realize they have invested resources in a trial that has not procured a single viable volunteer or specimen.
But collecting enough biospecimens is critical to the success of biomarker research and personalized medicine, which is why some industry observers are still shocked that more resources are not being dedicated to this purpose. For now, Oncology Nurse Advisor (ONA) explained that in addition to patient care duties, nurses are playing an increasingly central role in human biospecimen procurement in the absence of formal infrastructure . But this is likely not a sustainable solution and formal infrastructure is needed to streamline the biospecimen procurement process.
Speaking to ONA, Sharon Kaufman, M.S., research protocol specialist at the Mayo Clinic Cancer Center, explained that nurses have largely taken on stewardship of biospecimen procurement in clinical care settings. As such, they must balance their clinical duties to patients with the needs of research projects, which requires many to become familiar with the common biomarkers involved in the diagnosis and treatment of conditions endemic to their patient populations.
"Now, [nurses] need to be experts in collecting and processing blood and tissue; dissecting clinical trial protocols to determine the details of collecting and processing; helping guide patients through their treatment options, clinical trial options; and then monitoring vital signs and administering chemotherapy," Kaufman told the source.
This places a large strain on nursing staff members. Not only must they perform above and beyond in their clinical duties to avoid financial reductions due to performance shortfalls, but also dozens of research projects could be resting on their abilities to identify eligible patients.
Picking, packing and shipping
The actual procurement of biospecimens is not the only task being allotted to nurses on top of their regular clinical and professional duties. Kaufman told ONA that these workers are also often in charge of picking the samples from circulation, packing them according to specific regulations, and sending them off to the right place.
"The challenge is doing it all within the protocol-specified time frames, which are all different," Kaufman said. "It is more and more common that these details are so specific that they cannot be written into the protocol."
For more reliable biospecimen procurement, and to allow nurses to continue conducting their primary patient care and professional duties, a more centralized system of sample ordering, identification, and delivery could increase quality of the process for researchers while reducing strain on nurses.