Notice Number: NOT-CA-14-026
Release Date: February 18, 2014
National Cancer Institute (NCI)
The purpose of this Notice is to inform the extramural research community of changes to the Program Announcement PAR-14-031, "Specialized Programs of Research Excellence (SPOREs) in Human Cancer for Year 2014 (P50).
This Notice announces additional information related to the following sections of the FOA.
PHS 398 Research Plan (Research Project)
Specific Aims: the following paragraphs must be inserted at the end of this section.
Only Phase I and early Phase II clinical trials (generally non-randomized, small accrual (<100), investigating the activity of a single agent in a particular disease) will be supported by the SPORE FOA. SPOREs are strongly encouraged to establish collaborative clinical trial activities across NCI-funded activities early in the development of projects that have clinical trials/studies as their goals.
For multicenter, randomized Phase II therapeutic trials (>100 patients), SPOREs wishing to collaborate as an inter-SPORE endeavor or with investigators funded by other grant mechanisms, should use the appropriate NCI Disease Specific Steering Committees and their Task Forces (http://restructuringtrials.cancer.gov/steering/overview) working together to develop clinical concepts from early SPORE trials that could move forward, beyond SPORE grant support, to the NCI Clinical Trials Network (NCTN; formerly known as Cooperative Groups). Collaborative trials using this opportunity may also include correlative studies. However, correlative studies associated with an NCTN trial may be supported within a SPORE project.
It should be noted that a clinical trial may not be the goal of many SPORE projects. Some projects will reach a human endpoint by using human specimens in the laboratory to expand upon observations made in the clinic, a process known as “reverse translation.” However, when biomarker studies are ready for clinical trials, SPOREs are encouraged to collaborate with trans-NCI clinical trial mechanisms to validate the biomarkers clinically.
Appendix: A copy of a draft or Institutional Review Board (IRB)-approved clinical trial protocol, along with informed consent forms and a specific data and safety monitoring (DSM) plan, are required and should be included in the Appendix if the trial is already underway or is anticipated to begin within the first 2 years of an award. If the trial will be performed during the latter part of the grant term, submission of these items to NCI program staff is required prior to the initiation of the trial.