Tuesday, May 13, 2014

Show me the (“Fit-for-purpose”) Biospecimen Evidence Based Practices (BEBP’s) Data

By Lisa B Miranda

The term Biospecimen Evidence Based Practices or BEBP’s appears to have been recently coined by colleagues from the United States National Institutes of Health National Cancer Institute Biorepositories and Biospecimen Research Branch.  Last month, Engel et al published an article in Biopreservation and Biobanking titled National Cancer Institute Evidence Based Practices: A Novel Approach to Pre-Analytical Variability Standardization”. As many in the biobanking field are aware variance in sample management practices can affect biospecimen integrity and often alters quality.   Biobanks typically aim to address this issue via adherence to standard operating procedures and protocols, documentation of any inter-specimen variability for reference during analysis downstream, as well as implementation of automated sample processing technologies, which some believe may reduce technical inconsistencies often found in manual practice.  In Kelly et al’s article the cogent point is made that while internal standardization of biobanking sample management practices aides in optimizing pre-analytical variability of specimens at one’s own site, this does not address the equally important issue of managing variability across biobank sites.   Optimizing and understanding pre-analytical variability across sites is a common issue for an abounding number of biospecimen research collaborations (i.e. multi-center clinical trials) and network based biobanking activities (i.e. aggregation of and analysis samples across sites), etc.  

Looking back in retrospect from last year’s conference while looking prospectively to the 2014 conference, it is clear that quality-driven-collaboration is an ongoing theme echoed again this year by the theme of optimizing quality control and sample integrity.  In my opinion the one thing that ties these two themes together and addresses the issue of cross-site inter-variability is “fit for purpose” evidence based biobanking.   This approach advocates prospective development of BEBP’s, which regardless of site of origin should provide reproducible validated results.  Navigating “fit for purpose” evidence based protocol requirements requires a certain level of precision. Planning of which should be driven by the specimen, molecule and analyte of interest otherwise referred to as an SMA-approach. To increase the likelihood that a biospecimen collection is managed in a fit-for-purpose fashion, it is essential that biobanks and biospecimen resources prospectively define their procedures using an evidence based focus.  What isn’t so apparent is how to get there so that this idea can become a common reality. 

In 2012 I developed a fit-for-purpose evidence based protocol framework which was distributed in its early stages at when IIR’s conference was its 5th year.  In September I’ll be giving a talk with a colleague at IIR’s 7th Biorepositories and Sample Management Conference.  The talk will offer insight from a recent collaboration amongst pharmaceutical, academic and biotech colleagues with whom the fit- for- purpose evidence based protocol development framework has been vetted.  In this talk we plan to present a brief overview along with relevant lessons learned, feedback and take homes from presentation and peer based discussion amongst the broader biobanking community.  The technical and scientific framework is meant to function as a quality control instrument, consists of nine sections and is designed to offer utility in a two ways.  Firstly, it can be used as a guidance document (checklist and worksheet) and fit-for-purpose (FFP) planning exercise (to assist biobanks in understanding evidence based biobanking requirements) so that BEBP’s can be established in real time. Secondly, it can be utilized retrospectively as an internal audit tool (to ensure your biobank protocols, operations and equipment can support FFP sample management.)  The comprehensive document factors in best practices as well as relevant reporting guidelines (e.g. BRISQ).  With the advent of biospecimen science leading the way for evidence based biobanking practices, Biobankers have an amazing opportunity to impact both the biomedical research and clinical realms in a significant capacity.  This instrument if implemented across biobank sites could accelerate real time practice of evidence based biobanking and remedy the issue Engel et al raise regarding variability between multiple sites.  If all sites in an organization or collaboration incorporate this framework, they’d be more apt to increase proficiency of biospecimen collection quality and be more adept at ruling out variability between collections across sites.  If this topic and information interests you, we hope to see you at the conference September 8-10, 2014 in Boston.  Check out what we’ve got lined up.

Save your seat now and you could SAVE 15%. Use discount code XP1998BLOG. Register here.

About the Author:  Lisa Miranda is President and Chief Executive Officer of Biobusiness Consulting Incorporated, a biobanking and biotechnology commercialization advisory based in the Greater Boston Area.  She is known worldwide as a biobanking and clinical research subject matter expert.  Much of her work focuses on biobank strategic planning and/or development of biospecimen research applications and biotechnology commercialization.  She may be reached at: lisabmiranda@biobusinessconsulting.com

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