Precision Medicine’s Next Hurdle: Quality Management of Human Samples

February 15, 2018 Cornelia Truemner

As precision medicine continues to become more prominent, the use of human biological samples, such as urine, blood, tissue, cells, DNA, RNA and protein, is increasing in clinical development (see images below).  In fact, over 60 percent of all PAREXEL’s clinical data for biomarker-based, targeted treatments/precision medicines come from biological samples.  This trend will continue as R&D spend in personalized treatments is expected to double in the next five years, and in the same period, the number of research samples collected and stored will increase by 20 percent to over 2 billion samples[1].

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The rise in importance and number of samples raises questions and challenges for those managing these samples.  First, samples need to be handled correctly.  Mishandling can lead to testing not being possible, or worse, trial results being compromised[2].  Consider the complex ecosystem of laboratories, depositories and internal research and development facilities these samples go through in their lifespan, and proper handling becomes even more difficult.

It’s not only the physical considerations of sample management mentioned above that are important.  It’s imperative to know what the samples can and can’t be used for, based on agreements made with the patient, which are documented in the Informed Consent Form (ICF).  The ICF clearly states what specific research the patient’s sample can be used for, if and how long it will be stored after the study and if it’s to be used for a purpose other than the current research.

In addition, knowing where the samples are, their status against the study and ensuring the link between the physical sample and its resulting data are maintained, are also important.  Finally, as regulations and guidelines continue to change, being able to provide full information about the lifecycle of all samples is critical to maintain compliance, as well as sample integrity and security.

With all the complexities that come along with the increasing use and management of human samples, those leading clinical development, regulatory, translational and biomarker research need a clear understanding and road map to help them navigate these challenges.

This is essential at every phase of a sample’s life – from informed consent and collection at site, through in-study laboratory analysis and storage until destruction.  Sponsors must be able to ensure seamless and protocol-compliant collection of informed consent forms and samples, as well as streamlined sample logistics and associated data flows to meet regulations and enable reduced cycle times.

Having processes and technologies in place can also help enable real-time monitoring of sample collection at site, serving as the ultimate source for sample quality.  Providing this near real-time sample inventory transparency will allow companies to comply with constantly changing and/or recent regulations, such as ICH E18 Genomic Sampling Methodologies for Future Use, the EMA Guideline on good pharmacogenomic practice, FDA Common rule and ISO Biobanking Guideline.

Today, we are at an exciting and pivotal point in drug development.  The growth of precision, personalized and genomic medicines shows great promise, however having the right capabilities to manage the increase in human samples is critical.  In our second installment, you can learn more about each phase a human biological sample goes through in its lifespan, and how you can ensure it's handled properly for maintaining its compliance and integrity.

 

[1] Visiongain Biobanking Market Forecast 2016-2026

[2] “Precision Medical Treatments Have A Quality Control Problem.” All Things Considered, NPR, 29 Dec. 2017

 
Dr. Rico Berger
Senior Director, Worldwide Laboratory Logistics Services
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