Demonstration Project Participants at the July 28–29, 2003 Design Team meeting were asked to suggest a possible model for an NBN demonstration project. During the meeting, it became apparent that there were many possible approaches for initiating a demonstration project. The model described below provides a preliminary framework based on the discussion at that meeting. It is anticipated that this framework will require further refinement. The ultimate implementation of the National Biospecimen Network (NBN) is understood to be a complex undertaking. It therefore will be important to evaluate the feasibility of integrating multiple aspects of a national network by beginning with a demonstration project. The NBN Design Team recommended establishing a 3-year demonstration project, supported by a combination of public and private funds, with several important characteristics outlined in Table 8-1. The demonstration project should be able to perform the basic functions of the NBN, address specific challenges discussed in this Blueprint report, and meet performance characteristics to evaluate success. In addition, the demonstration project should be capable of quickly expanding to operate on a national scale. In considering the demonstration plan, the Design Team recognized the intrinsic value of incorporating the potential of existing biospecimen resource components as a backbone for the new system. As a starting point, the Design Team considered strengths in existing NCI resources in tissue collection and bioinformatics, and expertise in patient privacy issues. In addition, the expertise of private sector entities in establishing business operations and systems to collect, process, and distribute biospecimens to the research community is also highly valued. The Design Team considered and recommended a business model for the demonstration project that included the use of contracting mechanisms to build on these existing resources. One of the major challenges in managing the demonstration project will be integrating and coordinating the diverse activities of the six proposed Business Units. Therefore, it will be critical to identify a leader for the demonstration project to coordinate these activities. The NBN demonstration project leader would be responsible for insuring that milestones are met consistently, and anticipating next steps. This individual could draw upon the resources of a biomedical incubator such as the Foundation for the NIH (FNIH) and might ultimately serve as the Chief Executive Officer of the NBN if the demonstration project were successful. The NBN demonstration project should begin to disseminate biospecimens and associated data to researchers after one year of operation, and should aim to distribute 15,000–30,000 biospecimens annually after 3 years. The Design Team estimated that a demonstration project could cost approximately $15-20 million to develop and operate in the demonstration phase, and suggested that the NBN identify creative partnering opportunities with the public and private sectors to provide financial and organizational support for the initiative. Table 8-1. Characteristics of NBN Demonstration Project   DEMONSTRATION > > > > IMPLEMENTATION Module Basic NBN Functions Specific challenges Performance Characteristics Governance and Business Models Identify Board of Governors Establish Operations Center, hire key executive staff Establish oversight level QA, bioinformatics and communications functions Coordinate establishment of all functional business units Develop detailed business models, examining role of reimbursements and other fees Define milestones/performance characteristics for a formal evaluation of the NBN demonstration project by function and stage of development Evaluate cost recovery efforts Evaluate contributions to publications, scientific discoveries, patents, and technology development Management of Ethical and Legal Issues Establish bioethics and legal board Establish baseline consent procedures Revise/expand/optimize consent procedures as needed based on experience and any new regulations Assess compliance with Federal, state, and local regulations Assess compliance with Federal, state, and local regulations Biospecimen and Data Collection and Distribution Develop and implement Standard Operating Procedures (SOP) for collecting and annotating biospecimens Define common data elements for biospecimen annotation Develop criteria for distributing specimens to researchers that would eventually be adopted by the Biospecimen Utilization Committee Insure that SOP development is integrated with Bioinformatics and Quality Assurance efforts. Investigate approaches (i.e. follow-up questionnaires and/or linking to tumor registries) to collect longitudinal data with biospecimens Create incentives to encourage data submission from users Perform genomic characterization on a subset of biospecimens and provide this information to the research community Assess longitudinal data collection (i.e. success rate of patient followup) Document number of specimens collected and distributed Evaluate the availability and utility of genomic and proteomic data Test scalability of biospecimen collection system Bioinformatics and Data Management Work with Biospecimen and Data Acquisition Business Unit to develop common data elements and informatics applications Define minimal data set, associated data model, dictionary and baseline reports; deliver first functioning demonstration system Integrate work with Quality Assurance efforts Integrate best functions of existing systems Expand data model in context of advanced analysis needs Assess compliance with industry standards Evaluate facilitation of all business unit operations (internal) Assess facilitation of researcher access to clinical and specimen related info (external) Review effectiveness of analytical tools to further the research goals of users Communications Work with Specimen and Data Acquisition Business Unit to develop informed consent documents. Develop an NBN communications strategy that addresses marketing, public relations and outreach issues Sponsor focused investigations of ethical and legal issues to develop innovative approaches for obtaining consent and protecting patient privacy within the NBN Develop incentives to increase and retain participation Recruit more researchers, tissue donors, and (possibly) funders Assess patient recruitment for specimen donation Document number of researchers applying to use specimens through the Biospecimen Utilization Committee In order to streamline the development and integration of disparate aspects of the NBN, the Design Team recommended focusing the demonstration project on approximately five tumor types. The Design Team suggested that the tumor types for the demonstration project should be selected by weighing multiple characteristics including: incidence, mortality, tissue availability and quantity, as well as the availability of diseased and normal (or normal adjacent) tissues. In addition, tumors included in the demonstration project should require specimen acquisition sites to overcome diverse technical procurement challenges, including the impact of technical advances (such as needle biopsies and neoadjuvant therapy) upon tissue availability. After completing the demonstration project focused on five tumor types that meet all of these criteria, NBN specimen acquisition sites could readily expand to collect a broader range of tumors. In addition to addressing challenges involved in biospecimen collection, the demonstration project must develop approaches to encourage use of the resource by basic and clinical researchers. The NBN demonstration project should initiate concerted communication efforts to identify scientists with ongoing scientific research projects that would benefit from analyses of biospecimens from the NBN. These researchers could provide timely feedback that could be included as part of a formal evaluation of the demonstration project, and which would provide an early indication of the promise for implementing the NBN on a national level.

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