Request for Information (RFI): Optimization of Information Technology for Biobanks Collecting Specimens from Clinical Trials Sponsored by the National Cancer Institute (NCI)

Notice Number: NOT-CA-12-008

Release Date: February 6, 2012
Responses: Responses will be accepted through March 30, 2012.

National Cancer Institute (NCI)

The purpose of this Request for Information (RFI) is to gain feedback, comments, and novel ideas from interested members of the informatics/information technology community as well as from persons representing other relevant segments of scientific communities and the American public on the optimal directions and efficient implementation of informatics systems for the biospecimen resources supporting the NCI-sponsored clinical trials.

This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health (NIH), and/or the National Cancer Institute (NCI). The NCI does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information.

The Cooperative Group Banks (CGBs) represent collectively the biospecimen resource of the NCI’s Clinical Trials Cooperative Group Program. The purpose of the CGB network is to support biospecimen-based integral and correlative research on biomarkers in the context of NCI-sponsored cancer clinical trials. The CGBs create and maintain a readily accessible resource of quality, highly annotated human biospecimens from patients enrolled in NCI Cooperative Group Clinical Trials. Access to this resource is available through a fair and open procedure to qualified investigators in the cancer research community.  CGBs collect, store, and distribute specimens from patients treated in NCI-funded Phase III and large randomized, controlled Phase II clinical trials.  These collections are unique because the acquired biospecimens are well-annotated and associated with their corresponding trial-based clinical, treatment, and outcome data.  The goal of the CGB resource is to provide biospecimens for research involving assessments of clinically relevant biomarkers (e.g., development/validation of prognostic and predictive markers, molecular signatures), identification of therapeutic targets, and other novel translational research studies. Ultimately, it is desired that correlative analyses between clinical trial and biomarker data and biospecimen-based experimental data sets will lead to advances in biomarker-driven therapeutic strategies for cancer patients.  Clinical trial protocols under which the biospecimens have been collected can be accessed at: http://www.cancer.gov/clinicaltrials.

The CGB network is currently composed of multiple, geographically distinct biorepositories of well-annotated specimens. Each Cooperative Group Biorepository listed below may have several banks that specialize in collections of certain types of biospecimen. Each CGB is an integral component of one of the current nine NCI-sponsored U.S. Clinical Trials Cooperative Groups, which are as follows:

• American College of Surgeons Oncology Group (ACOSOG) Biorepository;
• Cancer and Leukemia Group B (CALGB) Biorepository;
• Children's Oncology Group (COG) Biorepository;
• Eastern Cooperative Oncology Group (ECOG) Biorepository;
• Gynecologic Oncology Group (GOG) Biorepository;
• North Central Cancer Treatment Group (NCCTG) Biorepository;
• National Surgical Adjuvant Breast and Bowel Project (NSABP) Biorepository;
• Radiation Therapy Oncology Group (RTOG) Biorepository; and
• Southwest Oncology Group (SWOG) Biorepository.

Currently, each of the existing NCI Cooperative Groups maintains their own informatics/information system for the management of biospecimens with customized workflows and vocabularies. Many Groups are associated with multiple banks and frequently, each of these banks operates its own biospecimen management system. Some Cooperative Groups provide coordination between individual banks and a central data operations center through a biospecimen tracking application. The connectivity between individual banks (which house biospecimen-specific data) and central data operations (which store clinical and trial information) is highly variable and generally limited.

The NCI is in the process of reorganizing the network of Cooperative Groups and NCI-sponsored clinical trials as NCI National Clinical Trials Network (NCTN)" (http://deainfo.nci.nih.gov/concepts/NCTN.pdf). In this context, plans are made to optimize informatics system for the reorganized NCTN, including informatics for biospecimen resources. At present, the NCI Cooperative Groups are in the process of adopting a common Clinical Data Management System (CDMS).

A future Funding Opportunity is being designed to support the informatics/information technology structure for the interoperability amongst the Cancer Cooperative Group Biobanks and supporting NCI components such as statistical centers. The general goals of the Group Banking Committee (Informatics Subcommittee) are to identify the optimal approaches for disparate data source integration and harmonization, establishing a standard controlled vocabulary, designing and developing a common data exchange protocol, and establishing a flexible and scalable architecture utilizing open standards.

This RFI is expected to aid NCI program staff members in the development of the planned funding opportunity. However, no applications for funding are being solicited at this time.

In order to better understand and anticipate the probable needs of the CGBs and optimal directions for their informatics structures and solutions, the NCI and Group Banking Committee Informatics Subcommittee seek input from interested members of the informatics/information technology community as well as other persons representing relevant scientific communities, including commercial and academic experts in the fields of informatics, information technology, biospecimen data integration and management, and related areas. Respondents are encouraged to provide, as concisely as possible, their input on any one or more of the following items (one page maximum per item, single-spaced):

Respondents are asked to briefly address the following aspects:

• Potential merits of adopting a single, hosted software system to accomplish the goals of the CGBs versus the benefits of establishing a Service Oriented Architecture (SOA) to accomplish the same objectives -- if possible, please discuss the technical, operational, and financial benefits and risks to both approaches;
• Any work initiatives of similar goals and scope (i.e., focused on the integration of disparate data sources and harmonization solutions) known to or performed by the respondent, the rationale for choosing specific technical approaches, and the high level development and implementation plan;
• Technologies, platforms, or paradigms that could be particularly useful for open standard data integration and harmonization in the context of this RFI;
• Project dependencies and responsibilities for CGBs to consider for successful design, development, and implementation;
• Potential roadblocks that could prevent the success of such an initiative (include those types of roadblocks that are practically known to exist as well as those that may be theoretically anticipated);
• Optimal method(s) by which the effort/cost of such a project could be reasonably estimated;
• Identify likely IT system integration issues that would optimize the efficiency of exchange of scientific, regulatory, and administrative data (e.g., Clinical Data Management System)

and

• Any other matter deemed relevant to the goals of this RFI.

Note: Do not include any proprietary or confidential information.

If you are willing to do so, please indicate your primary affiliation/role from the categories listed below:

• Academia (basic or clinical research);
• Small Business;
• Pharmaceutical/Biotechnology Industry;
• Federal Government;
• State Government;
• Healthcare Professional organization;
• Integrative Medicine Professional organization;
• Patient Advocacy Group;
• Country; and
• Other (briefly define).

Responses will be accepted through March 30, 2012. Please mark responses with this RFI identifier NOT-CA-12-008. Responses in electronic formats are preferred and can be e-mailed to lubenskyi@mail.nih.gov.

All individual responses will remain confidential. Any identifiers (e.g., names, institutions, e-mail addresses, etc.) will be removed when responses are compiled. Only the processed, anonymized results will be shared internally with NIH staff members and members of scientific working groups convened by the NCI, as appropriate.

Respondents will receive an automated e-mail confirmation acknowledging receipt of their response but will not receive any individualized feedback.

Inquiries regarding this RFI should be directed to:

Irina A. Lubensky, MD
Chief, Resources Development Branch
Cancer Diagnosis Program
Division of Cancer Treatment and Diagnosis NCI, NIH
EPN, Room 6032
6130 Executive Blvd
Rockville, MD 20892-7420
301-496-7147 Phone
301-402-7819 Fax