Day 1 Highlights - March 13, 2008
Anna Barker opened with remarks outlining the need to improve the methods in which biospecimens are collected, handled, and processed, noting that of the 350 million biospecimens in the U.S., only 30 percent of them are of high enough quality for research purposes. The quality needs to be raised across biospecimens in order for personalized medicine to be realized.
Carolyn Compton provided further context by noting key steps for improving quality including 1) Publishing NCI "State of the Science" best practices, 2) Harmonizing practices across the NCI and the greater NIH enterprise, 3) Partnering with accrediting and licensing bodies, and 4) Facilitating the creation of scientific, evidence-based practices for procurement, processing, stabilization, etc. NCI encourages cost recovery for handling of biospecimens and OBBR will be trying to provide guidance to the community to help them identify how much it costs them to collect, process, and store biospecimens.
Pat Brown from Stanford had a provocative view on needing to understand healthy tissues, not just those with disease. He called for large scale autopsies (approximately 10,000) of "normal" people and a mechanism for donating organs for tissue research, not just transplants.
Helen Moore from the BRN shared their efforts for knowledge-sharing for the field. The mission of the BRN is threefold: 1) Provide a forum for sharing research results on how biospecimen variables affect molecular analysis, 2) Generate new research data, and 3) Collaborate with other programs to accomplish 1 and 2. They operate the Biospecimen Research Database that collects and organizes literature about biospecimen research. They are also testing variation of protocols for collection, handling, storage, processing, etc and determining the implications on the samples. They are accessible at http://biospecimens.cancer.gov/.
Day 2 Highlights - March 14, 2008
Paula Kim from Translating Research Across Communities shared a compelling patient perspective and underscored the need for patients to understand how their tissues will be used. She explained it is difficult for patients to make decisions and sign consents if they are not informed. The results of poor quality biospecimens degrades public confidence, wastes patients' time and money, and could provide false positive or negative results. She emphasized the need for an infrastructure, resources, and best practices to support high quality biospecimen efforts. Patients believe their samples are being used in a "bigger, better" way and they are putting their trust in medical and research professionals. She drove home that this "needs to be right!"
There were several presentations that outlined the incredible variances that exist between institutions (including SPORES) handling the same samples as well as the same institution handling similar, but different samples. The results were almost alarming, but raised the awareness and importance for continuing research in this area and sharing best practices. Standard operating procedures were presented as an antidote for such variance. Gerry Thomas, from the Imperial College of London and also involved with the Wales Cancer Bank and the Chernobyl Tissue Bank, made a compelling argument for such procedures.
Elizabeth Hammond from the University of Utah presented a compelling call to action message. Her talk underscored the need for job aides, including videos, posters, kits, and downloadable forms, related to biobanking. She argued for standard training and sharing of research principles that we already know and everyone should adhere to (again, OBBR or BBC could play such a role). There was also discussion of involving CAP to incorporate good training practices based on these principles and requiring as part of the certification process. She also suggested financial incentives for making individuals adhere to the practices, for example by providing a CMS code to charge for the proper obtainment of a specimen. She also presented the idea for biorepositories to be assessed and high-quality banks be given a "Goodhousekeeping Seal of Approval."
Helen Moore closed the day with the following OBBR action items:
- Post presentations and poster files to OBBR Web site
- Establish a venue for publishing information about research on biospecimens, such as an online journal
- Develop a list of good principles presented at the meeting and post to the Web
- Define value for the patient
- Develop working groups for moving forward
