JOFOC Attachment-FFRDC Justification_06282024.pdf

CCCT Strategic Planning – FFRDC Justification, 06/28/2024

NCI Coordinating Center for Clinical Trials (CCCT) – Clinical Trials and Strategic and Analytic Support

Federally Funded Research and Development Center (FFRDC) Justification – Use of Institute of Defense Analysis/Science and Technology Policy Institute National Science Foundation FFRDC

The National Cancer Institute (NCI) Coordinating Center for Clinical Trials (CCCT) has a need for a contractor to support NCI with specialized research, strategic support, and technical analysis for CCCT’s clinical trials activities with the goal of enabling NCI and CCCT leadership to strategically plan, formulate, and implement policies, programs, and procedures to strengthen the NCI clinical trials enterprise.

This broad-based, strategically driven effort involves critical stakeholders in NCI’s clinical trials enterprise and requires integration, collaboration, and strategic coordination across various programs including but are not limited to the National Clinical Trials Network (NCTN), Early Therapeutics Clinical Trials Network (ETCTN), NCI Community Oncology Research Program (NCORP) trials, trials taking place through NCI's Center for Cancer Research (CCR), and trials taking place with NCI support (either in NCI-designated cancer centers or through NCI-funded grants). CCCT plays a key role in the coordination and collaboration among NCI’s various divisions, offices, and centers to support clinical trials and translational research activities across the Institute. Because CCCT’s work complements and bolsters cross-institute clinical trial activities, CCCT works closely with the Office of the Director, the Division of Cancer Treatment and Diagnosis, the Cancer Therapy Evaluation Program, and the Division of Cancer Prevention, among many other offices and divisions. CCCT also convenes extramural advisors to provide advice and insight on NCI’s clinical trials and translational research enterprise.

To accomplish the tasks outlined in the Statement of Work, the contractor must be independent and free of conflicts of interest, have technical and analytic expertise, and have an in-depth understanding of NCI’s complex clinical trials infrastructure and enterprise. The contractor will need to provide overall strategic planning clinical trials support, perform technical and analytic support, and engage internal and external experts to achieve consensus and to facilitate dialogue.

It is necessary that NCI contract with IDA/STPI to conduct this proposed effort for the following reasons:

(1) IDA/STPI’s Impartiality: IDA/STPI has a track record of impartiality in the realm of clinical trials and translational research that allows them to work in the public interest and operate as a strategic partner with NCI in an objective manner. In contrast, private sector firms, such as contract research organizations and other academic institutions, may be tempted to slant presentation of proposed approaches and interpretation of gathered data related to clinical trials research activities to enhance their ability to win future contracts and/or grants.

Additionally, external experts, who likely have affiliations with NCI grantee institutions or principal investigators, may potentially have biases and conflicts of interest that would taint their ability to present independent and objective recommendations to NCI. Because of IDA/STPI’s previous experience as an FFRDC in the arena of oncology clinical trials research, they have demonstrated that they do not directly stand to gain from recommended solutions and approaches to NCI’s clinical trials research enterprise. They remain a truly objective third-party. Additionally, when data need to be gathered, IDA/STPI is capable of

CCCT Strategic Planning – FFRDC Justification, 06/28/2024 not only collecting the needed data but also performing data analysis in a manner free from bias to allow for unprejudiced, impartial, and objective conclusions. As such, there is no conflict of interest in IDA/STPI supporting this task order. This factor will serve as a benefit to the government.

(2) IDA/STPI’s Confidentiality Capability: Confidentiality to protect sensitive information is another important feature of this FFRDC. In order to conduct specific studies and to gather data, IDA/STPI will require access to sensitive information in NCI databases, such as NCI’s Clinical Trials Reporting Program (CTRP) and NCI grants databases which contain data that are not publicly available. This access has been previously granted to IDA/STPI, who are knowledgeable about the content and structure of data in these databases. IDA/STPI has an excellent record of ensuring the confidentiality of sensitive government information not just with NCI but also more broadly with NIH and other government agencies.

(3) IDA/STPI’s Past Performance: One of the objectives in this proposed task order is to provide overall strategic planning clinical trials support which entails the identification of optimal approaches to implement high priority initiatives. NCI leadership then determines which initiatives should convene expert groups, subcommittees, and working groups. IDA/STPI is the only contractor with detailed and historical knowledge of the broad portfolio of NCI’s clinical trials enterprise and NCI’s extramural and intramural research infrastructure.

IDA/STPI is also familiar in the operations of NCI FACA advisory board committees. IDA/STPI staff have previously demonstrated capability in developing high-priority clinical trials initiatives for implementation in consultation with NCI and external stakeholders via concerted consensus-building. IDA/STPI’s knowledge and experience makes them uniquely positioned and prepared to provide technical and analytic support for the implementation of strategic planning initiatives and to further identify related research activities that align with NCI priorities with minimal disruption to the existing clinical trials process. A new contractor who does not possess the detailed and fundamental familiarity of the operations of NCI’s clinical trials systems which includes a diverse array of stakeholders would be unable to provide the required detailed and quality support for this project in a timely and efficient manner without substantial and significant onboarding by CCCT. Use of another contractor would cause unacceptable delays and strain on government resources at a time when NCI leadership has identified the need for strategic planning for clinical trials support.