Designing and managing a flexible and dynamic biorepository system: a 15-year perspective from the CPCRA, ESPRIT, and INSIGHT clinical trial networks

Hullsiek, Katherine Ha; George, Michellea; Brown, Shawn Kb

doi: 10.1097/COH.0b013e32833f2058
Biomarkers of outcomes of disease, treatment and complications: Edited by H. Clifford Lane and Jens D. Lundgren

Purpose of review: We provide a long-term perspective of our experience with designing and managing a successful biorepository system. We include a brief history, a description of our current process, and lessons learned.

Recent findings: Biologic specimens, collected and stored as part of HIV-related research for years, are now being used for biomarker analyses that have important implications for both AIDS and non-AIDS events. If appropriately collected, documented, and stored, biospecimens are a valuable resource that can help answer current and future scientific questions. International networks must be able to monitor and adhere to country-specific specimen use regulations. Specimens for human DNA research need increased levels of privacy protection. Issues to consider when designing a biorepository system include expertise, communication, data management, technology, standardized methods and procedures, shipping, and specimen use policies.

Summary: As biorepositories are an integral part of research their design should not be an afterthought. Good designs consider all stages of research, and the most critical components are expertise and planning. Successful biorepository systems must have a balance of flexibility and standardization. The need for adaptable data management systems, whether commercial products or systems developed specifically for the network, should not be underestimated. Investment in appropriate technology, including a barcoding system with high-quality labels and printers, will pay off in the long term. To meet the needs of emerging technologies, it is becoming increasingly important to document the conditions at the time of specimen collection and processing. Regular communication between all components of the biorepository system is critical.

aDivision of Biostatistics, University of Minnesota, Minneapolis, Minnesota, USA

bAIDS Monitoring Laboratory, SAIC-Frederick, Inc., NCI-Frederick, Frederick, Maryland, USA

Correspondence to Katherine H. Hullsiek, PhD, Division of Biostatistics, 2221 University Ave. SE, Suite 200, Minneapolis, MN 55414, USA Tel: +1 612 626 0314; fax: +1 612 626 8892; e-mail:

© 2010 Lippincott Williams & Wilkins, Inc.