Sample Banking for Future Clinical Research

Nov 11, 2013

You can find the full article version of this blog here.

Sample banking for future clinical research provides the pharmaceutical industry with new opportunities to obtain biological sample collections.  

However, several considerations, issues and challenges come into play.  

Regulatory Considerations

Country-related and global regulatory efforts are currently ongoing to harmonize the regulations governing sample banking for future clinical research.

ICH published guidance documents to harmonize standards between Europe, Japan and the USA.

Europe issued a proposal for new guidelines for data protection and privacy released in early 2012, which will take effect in 2016.

Japan issued a guidance outlining the general principles of pharmacogenomics in clinical trials and supporting the collection of future use samples. In 2008.

In the US, the FDA issued a draft guidance on January 2013. The “Modifications of the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the HITECH Act” became effective on March 26, 2013. On July 2011, HHS issued an Advanced Notice of Proposed Rulemaking relating to the Common Rule.

Operational Considerations

Operational considerations relate to accreditation and managing the process of sample procurement, storage, and de-identification.  

Case Studies

To make the most of sample banking, collaborations have formed.

Indiana University, Purdue University and the University Of Notre Dame CTSI have formed the Indiana Clinical and Translational Institute (CTSI). CTSI offers investigators a “one-stop” platform to request samples.  

RUCDR Infinite Biologics and BioStorage Technologies, Inc. have formed the Bioprocessing Solutions Alliance for the delivery of sample bioprocessing and biobanking solutions.

Ongoing Efforts

Several national and international groups have emerged to address issues of global sample collection for future clinical research.

Lina Genovesi, PhD, JD www.linagenovesi.com

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