Garbage In, Garbage Out: A New Look at Biospecimen Quality

Theral Timpson


If you had told me a year ago that there are no regulated standards as to the quality of the biospecimen samples that are used to conduct biomedical research, I wouldn’t have believed it. Yet that’s been the case.

This was brought to our attention by the indomitable Carolyn Compton, a former pathologist and now the Chief Medical Officer for the National Biomarker Development Alliance (NBDA). Carolyn served at the National Cancer Institute with the express purpose of bringing more awareness to the issue of sample quality. It was there that she came to connect the dots between poor sample collection, handling, and storage and the upward trend of non-reproducible research. Bad sampling is leading to bad science.

We were so struck by her hypothesis that we asked Carolyn to help us put together an entire series on the topic with links to each show posted below.

Jim Vaught started us off with an overview of the topic, giving a stunning example of how bad sampling is not just affecting research, but medicine as well. We then delved into just what can go wrong with sample collection and handling with Scott Jewell of the Van Andel Institute.

Diane Farhi is the Chief Medical Officer at Quintiles, the world’s largest CRO. Diane and her team have to deal with problems in collecting samples for clinical trials on a global scale. Next, we explored the new Biospecimen Science, a new sub-discipline which has emerged to offer training and basic education on the topic--albeit not near where it should be according to David Rimm of Yale. We talked with the director of the biorepository that handles samples for 4 NIH Institutes, Andy Brooks. He says that there are so many variables that are beyond our control that perhaps the best thing would be a score to test the quality of the sample in storage.

Carolyn returned to the program with some good news. Through NBDA she had been able to assemble much of the sampling community, including the head and former head of the College of American Pathologists (CAP), and they agreed on an initial framework for sampling standards. It was an historic event.

The Open Secret about the HER2 Assay with Jim Vaught

Biosampling Basics: Scott Jewel, Van Andel Institute

The Daunting Task of Managing Biospecimens at the World's Largest CRO: Diane Farhi, Quintiles

The Sad State of Biospecimen Science with David Rimm, Yale

"It's Pretty Bad": Andy Brooks on Sample Quality

Historic Consensus Reached on Biospecimen Standards: Carolyn Compton, NBDA

Note:  Thanks to Quintiles and Fluidigm for sponsoring this series.