Biobanks More Than Just Specimen Storage, Sites and Sponsors Say
Despite impediments brought on by the pandemic, sites and sponsors are increasingly turning to biobanks for more than just storage of trial specimens, using them to manage and analyze data, inform trial design and open new avenues of drug development research.
Reliance on biobanks is growing, especially in early-stage trials. “I would say that 90 percent of therapeutic trials are collecting samples for immediate analysis, and that percentage reaches 100 percent in the case of phase 1 trials,” Zuanel Diaz, director of the Protocol Support Laboratory and Biospecimen Repository Facility at the Miami Cancer Institute, told CenterWatch Weekly.
“This is a phenomenon we were not seeing 10 years ago. We see more pharmaceutical companies relying on biobanks to manage their samples. The companies derive benefits from the biospecimen expertise, which translates in quality of the samples and reliability on the analytical procedures. The biobank increases their samples’ utility rate, their operations’ sustainability and its staff increase their knowledge of cutting-edge technologies and advancements in correlative science.”
Sonia Abrol, vice president for software development and operations at WCG Velos, said that since the pandemic started, an increasing number of sites are inquiring about biobanking functionality. “The industry is still going for it,” she said. “They’re evaluating how they can utilize biobanks.”
Diaz said that with the advancement of molecular profiling technologies, storing samples obtained during patient treatment with experimental therapies provides an opportunity to analyze the samples after the trial is closed and results are published, and after the patient’s response and/or reaction to the treatment is known. That analysis “can lead to correlations and discoveries that were not thought of during the clinical trial design,” she said. “They contribute to the knowledge generated and, sometimes, to the design of the next phase in the drug development process.”
Biobanks also provide more secure specimen management, Diaz said. “If you rely on a biobank to manage the clinical trials samples, there is a higher certitude that those samples will be well-preserved, well-processed and with preanalytical variables documented, because the biobank functions with standard procedures, with chain of custody mechanisms and with technical personnel that have a sample-driven mindset.”
Sites also stand to benefit from streamlined procedures and time savings, says Dina Avery, assistant professor in the School of Health Professions at the University of Alabama at Birmingham. “I know from personal experience that clinical research coordinators appreciate biobanking coordinators because it saves them from collecting, processing and storing the consented participant’s specimen(s). Trained biobanking coordinators are also essential in abstracting data related to the specimen that will be entered into data-sharing [systems].”
Despite their growing relationship with biobanks, sites still need to make careful preparation. Avery said both the biobank and the site “must have smooth processes in place for collecting the biospecimens for research purposes. These two entities must clearly outline and agree on all processes prior to the start of the clinical trial. If not, this can cause a problematic situation that could have been prevented.”
And sites share the responsibility of minimizing vulnerabilities to data and sample loss with biobanks. Abrol recommended implementing an appropriately sized access protocol where researchers can assign samples to a study and track the transfer of sample custody. Another tool, a virtual repository, can map the processing, freezer storage and access rights associated with samples while mimicking a real freezer. Trials can also use technology to document the location and transfer of any samples to prevent sample loss and to also protect a sample’s lineage. “Sites have control over who they share with, but the appropriate technical infrastructure makes it easier,” she said.
Sek Won Kong, assistant professor of pediatrics at Harvard Medical School, said sites are using biobanks retrospectively and prospectively, and one major area of research for their use is in oncology. He said commercial biobanks have been successful and sites on the whole have benefited from being able to utilize samples held at biobanks. But the consent process continues to be problematic, he said, making it “difficult to tell” if sites in general had positive experiences working with biobanks, saying such a determination had to be made on a case-by-case basis.
“That’s the big area of the debate,” Kong said, adding that while the consent process has become broader over the past five years, especially at academic institutions, it remains an issue in some quarters — particularly among minority communities and patients with rare diseases. “They may have made a sample donation of a specific phenotype with altruistic goals in mind, but sometimes the consent doesn’t explain they have legal rights to some of the discovery. It’s a complex issue.”
Diaz concurs. “The use of the samples collected for the duration of the clinical trial and whether a portion of them will be banked for future research studies should be communicated to the patient, and consent of use should be obtained. Often this is the major limitation in the expansion of use of the samples.”
She added that processing protocols can create other limitations down the road. “Sometimes specific buffers interfere with downstream profiling platforms, [or] the temperature used to store the samples was not the optimal one. Sometimes a particular analysis can only be done in serum, for example, so if serum was not prepared from the blood at the time of collection, that particular analysis cannot be done. Sometimes a functional analysis in peripheral blood cells will provide further insight, but the cells needed to be stored in freezing conditions that preserved the cells’ viability. If this was not the case, the biobanked samples have limitations of use for functional analysis.”
Still, there’s no shortage of optimism about the use of biobanks in trials. “We are living in a new era, in regard to precision medicine,” Avery said. “Clinical trials involving precision medicine are very important because it is truly revolutionizing how physicians make key decisions related to the treatment and diagnosis of patients.” She said biobanks can provide data related specifically to a participant’s specimen, thereby creating genetic discoveries that can be used in clinical practice. “Biobanks and researchers are forming more collaborative networks because of the valuable data-driven biomarker discoveries.”