NeuroNEXT Informational Webinar for Applicants

October 13, 2022 | 12:00 - 1:00 PM

Contact: Joan Ohayon, RN, MSN, CRNP, MSCN
Contact Email: joan.ohayon@nih.gov
Date/Time: October 13th, 2022 from 12-1pm EST
Registration: Register in advance for this webinar:

NeuroNext logo

This webinar will provide an introduction to three recently published funding opportunity announcements (FOA) for the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT). The webinar will provide information relevant to the application and offer a forum for potential applicants to ask questions. · The purpose of these funding opportunities is to invite applicants to serve as the clinical coordinating center (RFA-NS-22-029) and the data coordinating center (RFA-NS-22-030), as well as participate as clinical sites (RFA-NS-22-031). NeuroNEXT provides a robust, standardized, and accessible infrastructure, designed to facilitate the development and conduct of exploratory clinical trials in neurological disorders.

NeuroNEXT Network Renewal Frequently Asked Questions

Application and Review General Questions

What is the page limit for the research strategy?

The limit is 12 pages. There was a typo in the CCC FOA. The Notice of Correction has been published.

Could you please clarify the Transition Plan for the sites that are not awarded in 2023 or if not re-selected after this new cycle?

A transition plan should include how the site will manage the enrollment/follow-up of participants in a currently active NeuroNext trial should the current site not be continued as a NeuroNext site in the next Funding Cycle. The plan may also include contingencies for identififying a substitute PD/PID or coordinator to assure continuity in the event one or both of these personnel leave the institution.

What metrics of data performance should be included for current/active NeuroNEXT sites and how far back should they go?

Per RFA-NS-22-031, only the metrics below (with the following clarifications) must be included in a tabular format for each NeuroNext trial that the submitting NeuroNext site (and any performance site linked to the submitting site) was actively enrolling in during the past 5 year funding cycle. If the trials initiated prior to the last funding cycle, the appropriate metrics (i.e., start-up, etc.) should be included.

 

  • The start-up time from award to IRB approval
    • This references to the date the site was selected to be a performance site in the NeuroNext trial (hereby referenced as selected site) to the date IRB approval was achieved at the NeuroNext site.
  • The time from initiation of contract negotiation with lead site to contract executed
    • This references from the date the NeuroNext site received notification it was selected to be a site in the referenced trial to the date the contract was signed at the NeuroNext site (hereby referenced as site activitation).
  • The time from award to first patient screened
    • This is referenced from the date the NeuroNext site was selected to be a performance site in the trial (see first bullet above) to the date the first patient was screened at the selected NeuroNext site.
  • The time from award to first patient enrolled
    • This is referenced from the date the NeuroNext site was selected to be a performance site in the trial (see first bullet above) to the date the first patient was enrolled into the trial at the selected NeuroNext site.
  • The enrollment rate
    • This references the average monthly rate of enrollment at the NeuroNext site.
  • The total number of patients enrolled at the site
    • This metric should reference the number of total enrolled patients at each NeuroNext site for the duration of time the site was actively enrolling patients into the trial.
  • The accrual ethnic, racial and gender distribution
    • This metric should reference the percent of the enrolled population at the NeuroNext site that were non-white and were female.
  • The proportion of patients lost to follow-up
    • This metric should reference the percent of enrolled subjects at the NeuroNext site that were lost to follow-up as defined per the trial protocol.
  • The number of protocol violations at the site
    • This metric should reference the total number of protocol violations at the NeuroNext site as defined per the trial protocol.

What metrics of data performance should be included for new site applications and how far back should they report?

A new site application should include trials the submitting new site has participated in or initiated during the past 5 years. These should include any NeuroNEXT trial (if any) and additionally include other NIH or industry funded studies from the past 5 years that would reflect their capability of being a successful enrolling site in current NeuroNext trials (applicants are enrouraged to prioritize NIH trials and indicate which trials are NIH trials and which trials are non-NIH trials). New sites should describe their accomplishments in implementing each neurology clinical trial and must include their efficiency in starting these trials (e.g., time to site activation, time from activation to first patient enrolled, etc.), efficiency of enrollment (e.g., number of subjects enrolled, monthly enrollment rate), and subject retention rate in their studies.

Are multi-PI applications and/or multi-institutional applicants accepted?

Yes, multi-PI applications are allowed. Institutions proposing multiple PIs should demonstrate that the investigators have complementary and integrated expertise and skills. Multiple institutions can apply as one clinical hub or as partners, but similar justifications are needed.

Can the applicant have partnerships with industry personnel?

Yes. It is encouraged to describe any special expertise or unique strengths partners bring to the collaborative effort.

Must the $50K for Junior Investigator go to one person or can it be split?

The $50K is for one junior investigator. Per the Funding Section of RFA-NS-22-031, the NeuroNext site is expected to support at least one early-stage investigator annually for a maximum of two years, and must plan on allocating a minimum of $50,000 in direct costs per year toward salary support for each candidate selected.

For the NNEXT trainee, since 50% protected time is requested to support research, can this be opened up to fellows in lieu of an assistant professor?

Yes

How should we answer human subjects question since this is for the infrastructure?

Since this is an application to build infrastructure, it is NOT considered human subjects research.

Are biosketches required from all potential investigators?

Biosketches are required for all key personnel.

What materials should I put in Appendix?

Only limited Appendix materials are allowed. Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. For CCC application (RFA-NS-22-029), include gene therapy-based protocol synopsis and statistical advisory plan.

Referencing RFA-NS-22-029, where do we include the standard operating procedures (SOPs) used by the CCC in the implementation of multi-center clinical trials?

Please include the SOPs in table format (1-2 pages) under Facilities and Resources. This can be referenced in the Research Strategy section.

May the CCC provide support for Committee Co-Chairs to pay stipends for Education and DEI/Recruitment/Retention Co-Chairs, etc. if they are funded NeuroNEXT PIs?

Yes

What should be budgeted in the CCC grant to support EOB meetings? For example, should travel, lodging, food for the EOB members be budgeted?

Only travel & per diem for the CCC & DCC staff needs to be included. The EOB is managed by NINDS contractors so EOB member travel, etc. is paid by NINDS through the contractors.

 

GTC-related Questions

Should the CCC have the members of the GTC committee selected and named in the grant?

Yes.

Who will make up the GTC?

The consortium should be led by 6-10 members with expertise in gene therapy and gene- targeted therapy, rare and ultra-rare diseases, clinical trial design and execution, and specifically early phase, first in human or first in disease trials. GTC members can be from academia, industry, nonprofit organization or any eligible US organization.

Should GTC members receive salary support or stipends for their participation from the CCC budget?

No, the GTC members will be paid as consultants using trial-specific mechanisms as they reach the Network.

Would GTC members be selected from NN sites or can they be from non-NN sites?

GTC members can be from NN or non-NN sites.

How are trials that come through the GTC funded – does the clinical PI submit through regular NN grant processes?

Trials are funded using Other Transactions Authority (OTA). There will be separate Research Opportunity Announcement.

How will the GTC and the NN Executive Committee interact?

The NN Executive Committee will activate the GTC when gene therapy trials are brought to the network.

Will the DCC lead be on the GTC (one of the 6-10 spots)?

No. The DCC and CCC PIs will be involved with the GTC, but not count as members.

Will all NN sites have the option to be part of the gene therapy trials, meaning will the process for site selection for the gene therapy trials be the same as for other NeuroNEXT trials?

The sites involved in the gene therapy trials may be NeuroNEXT sites or external sites, depending on individual project needs. It is expected that only a small number of sites, or in some cases a single site, will be involved in some of the trials, due to the ultra-rare nature of the disease and affected patient population and intervention.

Will NINDS research or program staff be on the GTC (science program officer or other roles)?

NINDS will have a GTC liaison but will not count toward the 6-10 members.

Can the CCC budget for GTC in-person meetings or would those costs go in the trial budgets?

NINDS will fund the consulting of the GTC members through a directed Resarch Opportunity Announcement (using OTA) at the time the potential trial reaches the Network.

Since at least one example of a gene or gene-targeted therapy trial should be illustrated, what materials should be included?

Protocol synopsis and Statistical Analysis Plan

Will clinical sites with capabilities to conduct gene-based and gene-targeted therapies have higher priority?

It will not be a separate selection criterion because it is understood that too many ultra-rare diseases exist and are seen in specialized clinics across the country to be covered by the Network, and that ad-hoc sites will be likely be needed in many cases.