There is a well-recognized need for standardized biospecimen guidelines—from sample collection and processing to storage and use in research. The NCI has been working to develop such guidelines through its Best Practices for Biospecimen Resources, Biospecimen Research Network, and caHUB (the Cancer Human Biobank) initiatives.
“We view our role as serving academics, industry, and government. If everyone in R&D is able to move forward more quickly, then patients will benefit,” said Helen Moore, Ph.D., biospecimen research network program manager, office of the director, NCI. A lack of standardized, high-quality biospecimens has been widely recognized as one of the most significant roadblocks to the progress of cancer research.
NCI published its first Best Practices in 2007 to provide guidance for Biobanking, including standardized procedures for collection, processing, storage, and distribution. These guidelines were expanded this year and now include a management and operations section with an expanded informed consent and custodianship section. It is open for public comment on the Federal Register. Dr. Moore said the guidelines will keep changing because the science will continue to change.
“We did a survey of investigators before deciding to build caHUB, and the results were remarkable—the issue of accuracy of research data was resounding. Investigators were clear they really weren’t sure if their results were solid due to variation in specimens.”
The Biospecimen Research Network is funding a study that is evaluating how pre-analytical variables affect the molecular integrity of specimens. There are currently seven investigator-driven studies and one larger study with several investigators. Areas of interest include blood processing, mass spectrometry, as well as protein and gene expression in fixed and frozen tissues.
caHUB will ultimately serve as a centralized, nonprofit public resource for human biospecimens and associated high-quality data acquired via an ethical framework, as well as a source of high-quality Biobanking services. NCI has issued several RFPs—the most recent for collection of cancer tissues, as well as one for informatics and a comprehensive biospecimen resource, which will be awarded to one or more existing facilities. According to Dr. Moore, the initial part of this project is being paid for via stimulus funding. “This is not an area that has been funded in the past, but now there is a lot of job creation by putting these opportunities out to the world.”