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Applied Clinical Trials
There are scarce or illdefined national and international regulations on quality control and standardization of biorepositories.
Clinical research is dependent, in part, on the availability of and access to high-quality specimens stored at large-scale biorepositories. These biospecimens, useful for a wide range of research applications including genomics and proteomics provide a key to unlocking information that can lead to medical discoveries and—in compliance with appropriate regulatory controls where required, such as informed consent and IRB oversight—new drugs and diagnostics.
Yet, poorly implemented lab collection, processing, and storage can foster conditions that erode specimen quality—particularly for DNA and other molecules—and consequently affect the quality of research. In a worst case scenario, the most minute quality degradation could potentially lead to unreliable data and skew clinical research.
Surprisingly, given the vast body of research dependent on biorepository storage, there are scarce or ill-defined national or international regulations on quality control and standardization of biorepositories.
Alliances among owners of biorepository facilities and clinical trial and academic collaborators, and our industry's commitment to helping generate quality research, means we should take a leadership role in promoting industry-wide QA/QC standardization in biospecimen storage and research. To start, here are four simple and achievable steps:
Acknowledge the pressing need for uniformity and consistency. In 2011, the National Cancer Institute released its updated "NCI Best Practices," addressing biospecimen resources. The manual is exhaustive in its recommendations and guiding principles for biorepositories, but does not address specific laboratory practices or quality controls.
These guidelines are an important step, but, the concept of standardization for helping to ensure the quality of biospecimens stored in biorepositories requires more of a concerted effort. Best practices for maintaining integrity of specimens should be industry-wide, uniform in application, and global in scope.
Participate in specimen biorepository accreditation programs. Since 2011, the College of American Pathologists (CAP) has offered a first-of-its-kind, peer-reviewed biorepository accreditation program, developed to improve and standardize quality and consistency in collecting, processing, storing, distributing, and computerizing information for biospecimens while ensuring the quality of human specimens and genetic material. Participation is voluntary, but it is incumbent on our industry to enthusiastically commit to this type of accreditation.
Encourage sponsors/collaborators to work with accredited biorepository labs. While academic and clinical researchers have historically worked with specimens available through biobanks, increasingly, pharmaceutical companies are outsourcing central lab functions to a variety of labs that maintain specimen biorepositories and participate in clinical research.
Investment in front-end planning. All biorepositories should require extensive planning with collaborators before implementing specimen collection and storage on their behalf to account for all potential future applications. The scientific teams at quality biobanks have the expertise to provide guidance on optimal storage procedures, including temperature, to avoid degradation and preserve the integrity of specimens under a variety of potential usage applications.
The industry should take the lead in developing a planning protocol that takes into account the current and potential usage of the samples as well as the stability of the materials being stored.
Christopher C. Fikry, MD
Quest Diagnostics Clinical Trials
E-mail: [email protected]