RFA-CA-23-021
Is more than one application per institution permitted?
No. Only one application per institution is permitted.
On the application face page, should SDMC applicants answer yes to human subjects involved?
Yes. The SDMC will be involved study design and may have access to personally identifiable information of study participants.
Will the two Vanguard MCD arms involve testing for at least one overlapping type of cancer, and should we anticipate processes for the relevant comparisons across tests?
No. MCD tests may, but are not required to, assess overlapping cancer types. The MCD assays have not yet been finalized for the study. The CSRN will not be designing studies to compare assay performances during this funding cycle. The Vanguard Study is intended to be a feasibility study for a future, large, randomized control trial.
Can prior studies that are not cancer studies be listed in the application to demonstrate past experience?
Yes.
Should SDMC applicants include novel statistical methodologies in their proposal?
The review criteria acknowledge that clinical trial applications may include study design methods and interventions that are not innovative by themselves as long as these methods address important questions or unmet needs. This Network will conduct clinical trials and other types of research studies to address the clinical utility, effectiveness, implementation, and other questions related to established and emerging screening methods, technologies, and strategies. Applicants may choose to highlight their experiences with novel approaches and statistical methodologies.
Additional review criteria specific to this FOA under “innovation” does include the following reviewer considerations:
- Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?
- Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?
- Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are applicants required to purchase a new instance of Medidata Rave for the CSRN if they own an existing instance?
Yes.
What Medidata Rave related costs should be included in the budget?
NCI will cover the license, hosting, and maintenance for Medidata Rave and Targeted Source Data Verification (TSDV) under separate contract. Applicants will be responsible for the initial URL set-up and routine professional services support. In addition, applicants will be required to cover training costs as needed.
Last updated: 02/14/2023