February 19, 2021
National Cancer Institute (NCI)
The National Cancer Institute (NCI) is seeking information on opportunities to leverage populations participating in NCI’s National Clinical Trial Network (NCTN) and Community Oncology Research Program (NCORP) for observational cohort studies to fill evidence gaps in cancer survivorship knowledge.
Key Terms for this RFI
Cancer survivorship research: research with the goal to improve the health and well-being of cancer survivors and caregivers providing care to survivors. See the NCI’s Office of Cancer Survivorship webpage for an expanded definition.
Observational cohort study: a longitudinal study that follows a group of people, such as cancer survivors and/or their caregivers, over time to collect data. Collection of follow-up data could be active (e.g. clinic visits, administration of surveys) or passive (e.g. linkage to existing datasets).
Observational cohort studies of cancer survivors have contributed substantially to our knowledge about the short- and long-term health outcomes of cancer and its treatment, allowing for the identification of key factors that may inform interventions and clinical guidelines to mitigate adverse health outcomes. Cancer survivors recruited into observational cohort studies are often identified through cancer registries, clinical settings, or advocacy/community groups and thus are more likely to be representative of the general cancer survivor population than those enrolled in clinical trials, who tend to be healthier, younger, and less diverse. However, in observational cohort studies, it can be time-consuming and costly to collect clinical information, including data related to treatments received, which is necessary to answer certain research questions. This type of information is usually readily available in clinical trials.
Thus, ancillary studies using established patient populations currently or previously enrolled on NCTN or NCORP clinical trials - or studies utilizing other designs - have the potential to contribute to cancer survivorship knowledge, which is complementary to that being obtained in traditional observational cohort studies. These populations are typically well-characterized for cancer diagnosis, medical history, cancer treatments received, and treatment-related outcomes. Further, compared to traditional observational cohort studies, NCTN or NCORP studies are more likely to include rare cancer populations and focus on newer cancer therapies, including immunotherapies, thereby providing opportunities for collecting cancer survivorship information pertaining to these and other knowledge gap areas. In a 2019 report on Cancer Epidemiology Cohort Studies by the NCI National Cancer Advisory Board’s Ad Hoc Working Group on Strategic Approaches and Opportunities in Population Science, Epidemiology, and Disparities, it was recommended that “When considering the establishment of new survivor cohorts, opportunities to leverage the patient populations available through the NCI-supported cooperative clinical trials groups and the NCI Community Oncology Research Program (NCORP) should be given strong consideration.” This recommendation is aligned with NCI’s considerable investment in these research infrastructures and the unrealized potential of their study participants to contribute to knowledge about cancer survivorship.
A number of methodologies could be utilized to leverage NCTN or NCORP patient populations for observational cohort studies to fill evidence gaps in cancer survivorship knowledge. These methodologies include, but are not limited to, the collection of additional data as part of the longer-term follow-up of NCTN or NCORP study populations or the linkage of existing NCTN or NCORP study data to “big data” sources (e.g. Centers for Medicare and Medicaid Services data) to examine longer-term survivorship outcomes.
Through this RFI, the NCI seeks information on:
Specific research questions or evidence gaps in cancer survivorship knowledge that can be addressed using existing NCTN and NCORP study populations.
In addition to the specific research question(s), please include information on:
How to submit a response
Responses will be accepted through 05/03/2021. Please limit your response to two pages or less. Responses in electronic format are preferred and can be e-mailed to NCI_CancerSurvRFI@mail.nih.gov. Please include the Notice number (NOT-CA-21-036) in the subject line. The submitted information will be reviewed by NIH staff. Every respondent will receive an automated e-mail confirmation acknowledging receipt of a successfully submitted response but will not receive any individualized feedback.
Responses are entirely voluntary and can be anonymous. If willing, you may indicate the environment to which your perspective pertains (e.g., academia, clinical research, clinical practice). No proprietary, classified, confidential, or sensitive information should be included in your response. 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 any member of scientific working groups convened by the NCI, as appropriate.
This request 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 NIH 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 NIH will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. However, responses to the RFI may be reflected in future funding opportunity announcements. The information provided will be analyzed and may be aggregated in presentations and reports. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).