Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Product Development Workshop Summary (2011) / Chapter Skim
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5 The Use of Biospecimens in Precompetitive Collaborations
5 The Use of Biospecimens in Precompetitive Collaborations
Pages 31-44
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From page 31... ...
Biospecimens stored by investigators in industry and academia and the data derived from those biospecimens represent a considerable resource of genetic and genomic information that can be used to develop individualized treatment regimens or even drug and diagnostic devices. Since the value in these samples lies in their inherent potential for use in discovery, biospecimens are prime candidates for collaboration and coordination.
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From page 32... ...
Most researchers also have few incentives to share their samples, further contributing to wide variation in the quality and accessibility of samples for research. In acquiring biospecimens for the Cancer Genome Atlas Project, which is seeking to identify genomic changes occurring in cancer and make those data publicly available, NCI identified a large number of problems with existing samples.
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From page 33... ...
. As an example, Compton cited a study of colon cancers showing that the time of intrasurgical ischemia while a tumor is anoxic dramatically affects gene expression in removed tissues (Spruessel et al., 2004)
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From page 34... ...
These best practices represent a set of unifying policies and procedures for biospecimen resources across the United States, although NCI does not have the authority to enforce these guidelines, which means that they must be adopted voluntarily. However, Compton did suggest that a new focus on the quality of samples will create incentives for scientists and publishers to question the quality of the samples on which research or a publication was based, and "this will change the culture." Also, the existence of a guidebook and an expanding science base on the factors that affect samples will lead researchers to want to do the right thing.
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From page 35... ...
The vision of the institute, according to Helphingstine, is to conduct a longitudinal study of Indiana's population in which biological specimens are linked with clinical outcomes data from the Indiana Network for Patient Care to create a novel and powerful research platform that will facilitate basic and translational research breakthroughs and lead to
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From page 36... ...
With the ability to query more than 8,000 clinical, laboratory, and outcome variables, "you can design studies that never were possible to think about before." As an example, Helphingstine mentioned a study enabled by the institute on coronary artery disease, which is examining 1,500 individuals -- 750 individuals with documented history of the disease and 750 in the control group, with the control population being annotated to ensure they are not on statins, do not have diabetes or hypertension, and so on. Clinical information on study participants can be retrospectively and prospectively updated from the electronic medical record at any time to gather additional phenotypic information on study participants and to select biospecimens for discovery and validation studies.
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From page 37... ...
SOURCE: Fairbanks Institute for Healthy Communities, 2010. ers." People in the study are told that their medical record data will be made available and they may be contacted for more samples or information in the future.
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From page 38... ...
Assurance from the International Standards Organization ensures consistency, imposes continuous quality improvement, and reduces problems associated with staff turnover and succession. In the UDBN's first phase, it established a biobank for advanced sample management by collating samples from disparate collections, standardizing them and their associated data, and making the samples available for further investigation.
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From page 39... ...
Fairness to the subject involves guaranteeing privacy and confidentiality, the ethical use of samples and data, consent management (including national and open methods to permit effective withdrawal of consent) , and public engagement with the work and its goals.
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From page 40... ...
Biobank Consortium is to develop a virtual biobank using an automated online sample request management system for use across multiple CTSA centers with samples maintained at their home institutions, said Lorraine Frazier, professor of nursing and assistant dean and department chair of Nursing Systems at the University of Texas Health Science Center in Houston. At the Houston site, the biobank began as a manual system with more than 48,000 patients and more than 188,000 samples.
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From page 41... ...
Individual sites also make sure that sample-related data, clinical data, and patient consent variables are migrated from paper to electronic format; that samples and data are consented for secondary use; and that the data are validated. The benefits of membership include improved synergy and interactions across the institutions through sample sharing, acceptance of a business plan and cost recovery model, use of the online sample request management system, and lower costs for entry and maintenance than for the closed data models inherent in commercial software solutions.
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From page 42... ...
A paper published in Nature Genetics used almost all of the academic samples that were available at the time to investigate a genetic variant involved in drug-induced liver injury due to flucloxacillin (Daly et al., 2009)
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From page 43... ...
However, the business value of the collaboration is considered low internally, partly because there is a view that large consortia never deliver anything. Additionally, external and internal stakeholders may need to okay or endorse a specific project, and academic partners sometimes expect that industry will foot the bill for the research.
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