Executive Summary
Biospecimen and Data Collection and Distribution
An overriding principle for the NBN must be that biospecimens for banking (collected for
storage in and distribution by the repository) are obtained only after all patient diagnostic needs
have been met, and subject to appropriate bioethical structures and procedures to ensure patient
protection. The NBN would be distinguished from existing resources for tumor tissue and other
specimens by highly standardized procedures for collection, processing, storage, annotation, and
distribution. The NBN would be developed to provide biospecimens and clinical information in
compliance with Federal, state, and local regulations.
The NBN should have a comprehensive representation of a broad diversity of disease and human
populations. Biospecimen donors should therefore reflect the broad range of ethnicities,
socioeconomic groups, and other demographic subgroups in the United States. The NBN should
pursue the selection of collection sites that will increase the genetic and geographic diversity of
its biospecimens.
In particular, the Design Team made the following key recommendations:
Recommendation 1. The NBN should be organized as (a) a decentralized network of
collection facilities with regional storage, possibly of nonprofit, tissue-repository
organizations located near academic medical centers and community-based hospitals that
serve large and diverse patient populations, and (b) as a virtual data repository networked
across the nation.
Incentives tailored to each kind of source should be developed to encourage many entities to
participate. For example, community hospitals, which could conceivably provide the largest
volume of specimens for the NBN, would need incentives and assistance to develop the
experience, infrastructure, and understanding of research necessary to establish viable collection
centers.
Recommendation 2. Specimens from all cancer types should be collected (with matched
normal specimens, whenever possible), but the NBN should be structured to provide the
quantity and diversity of biospecimens required to meet researcher needs.
The repository should consist of high-quality biospecimens appropriate for genomic and
proteomic studies, and the type of biospecimens stored in the repository should be determined by
an ongoing review of researcher needs.
Best practices should be incorporated and/or developed for every aspect of biospecimen and data
collection, processing, storage, and distribution in the operation of the tissue repository, and
should be consistently applied through the use of standard operating procedures that would be
monitored. Biospecimens and data should be collected from sources meeting NBN criteria, while
applying standardized clinical annotation. A minimal dataset would be established for each
specimen, with collection of additional longitudinal data for a high percentage of specimens, and
provision of genomic- and proteomic-based data. The annotation of clinical and pathological
data about the biospecimens would be quality controlled and standardized across collection sites.
It is recognized that the costs for these associated data are likely to be substantial, and success in
obtaining these data will require innovative solutions.
In the NBN, distribution of specimens would be guided by a Biospecimen Utilization Review
Committee using a peer review process that would evaluate researchers’ needs against competing
demands for specimens.
Recommendation 3. It should be expected that validated, investigator-derived data using
NBN resources be submitted to the NBN and linked back to original NBN tissue samples.
An expanded dataset, created by the return of this experimental data to the NBN, could be made
available to all investigators. It is recognized that this function will take substantial time and
effort to establish, and the NBN will have to create incentives to encourage researchers in the
public and private sectors to submit research data.
|
