FAQs From Informational ERN Webinar February 11, 2020 for RFA NS -20-028

HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

  1. Will the slides be made available?
    NIH will post the webinar slides on the pain consortium website. The Office of Pain Policy and Planning will post a tweet from @NIHPainResearch when the slides are available.
  2. If the study is sufficiently powered to determine efficacy at the submitting institution, are additional clinical sites required to be responsive to this RFA?
  • Use of the Clinical and Translation Science Award (CTSA) Program hubs clinical sites is encouraged, but not required.
  • Principal Investigators (PIs) will need to determine whether they have an appropriate cohort through their institutions. It is important to consider whether the PI’s institution has a population that can inform clinical practice guidelines. If the PI’s institution does not have a large enough population or a population with sufficient diversity, reviewers may perceive this as a weakness during peer review.  If additional sites are needed for recruitment from collaborating institutions, PIs should reach out to the CTSA program hubs. 
  1. Should the budget include the PI’s effort at each CTSA site plus study coordinator or will each CTSA site get a per patient reimbursement?
    Generally, budgets for the individual CTSA sites are based on per patient reimbursement.  However, the final budget for each site is established through negotiations between the PI institution and the participating CTSA sites.
  2. Could you talk about the matching requirement for this RFA?
    There isn’t a specific matching requirement for non-profit organizations. The language about matching in the NOFO is specifically related to for-profit companies.
  3. We are using two approved devices in a combined sensor. Each device has FDA approval. Does this satisfy FDA requirements?
    If you are comparing two different FDA approved (or exempt) devices, then the grant application would be responsive to the RFA.  You should contact the FDA however, to ask if the combined sensor requires approval or is exempt.
  4. If you could provide one key difference between collaborative – cooperative--agreements and the non-collaborative agreements, what would that be?
    The correct term is cooperative agreements. Cooperative agreements involve substantial interaction with NIH staff.  A key component of cooperative agreements is the requirement of milestones.  NIH staff will work with PIs to establish the milestones for the project prior to making the award.  If the milestones are not met throughout the course of the study, NIH may stop the study. 
  5. Are all CTSAs eligible to be chosen as a study site? How can we make sure applicants know we would like to be a site?
    Please contact the specific CTSA point of contact listed on the Trial Innovation Network website to determine if an individual CTSA site wishes to participate.
  6. Does the clinical coordination center help with recruitment? Do they offer a study website and recruitment portal?
    Yes, the clinical coordination center will help each individual trial.  The TIN will assist PIs in the development of a recruitment plan during the UG3 – planning - phase. The funded ERN studies currently are in their planning phase and are working closely with the TIN.  Funded PIs will meet face-to-face with the TIN teams during the kick-off meeting, including staff who can help with recruitment.
  7. Can you please send the contact information for the right contact person?
  1. Do PIs need to submit a letter of intent?
    A letter of intent is desired, but not required.  Letters of intent are helpful for NIH staff, as they allow us to better manage the workload involved in reviewing applications.  They also help program staff try to ensure that your application will be responsive to the RFA. Letters of intent should be sent to Linda Porter at porterl@ninds.nih.gov .
  2. How do we get the drug?
    The Principal Investigator (PI) is responsible for getting study drugs.  It is the PI’s responsibility to make sure that the drug is available and approved for the study.
  3. Are dosing and efficacy studies responsive to the NOFO?
    Yes, provided the trial does not need an Investigational New Drug (IND) for testing.  For example:  If you are testing a drug that is already approved at one dose for a particular pain condition, then you could propose a dosing trial if the study maximum dose does not exceed that which is approved for use.  
  4. Can a drug approved by the FDA for other purposes be tested for pain in a trial under this NOFO?
    This NOFO will not support studies of interventions or investigational products that require an Investigational New Drug (IND) application. It is the responsibility of the investigator team to contact the FDA to determine if an IND is required. We would encourage PIs to contact the FDA soon if there is a question.
  5. Who should contact the FDA?
    The Principal Investigator is responsible for contacting the FDA.
  6. Will continuous submission extended period of 2 weeks be allowed to investigators?
    This RFA does not allow for continuous submissions. The deadline for all applications is March 24th.
  7. What additional opportunities are available?
    Another NOFO was recently released by NCCIH soliciting additional PRISM network studies.  PRISM trials are pragmatic trials testing pain management strategies in large healthcare systems. The contact person is Dr. Wendy Weber at NCCIH. See Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM)
  8. Why are behavioral interventions a low priority for this RFA?
    The low prioritization for behavioral interventions – especially through self-management - is based primarily on an analysis of the HEAL portfolio.  All awards made for the first round of ERN effectiveness trials use behavioral approaches.  In addition, there are funded PRISM trials testing behavioral interventions as well as studies in other HEAL programs.  

General ERN FAQs

Q. What is the HEAL initiative and how does this NOFO support the objectives of HEAL?
The HEAL (Helping to End Addiction Long-term) Initiative, is an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. The initiative will bolster research across NIH to improve treatments for opioid misuse and addiction and to enhance pain management. NIH will work with partners from the biopharmaceutical industry to develop a data sharing collaborative, new biomarkers for pain, and a clinical trials network for testing new pain therapies. NIH also will enhance the pipeline of non-addictive treatment development and enhance clinical practice support for pain management. This NOFO seeks proposals that will inform clinical practice through evaluation of the effectiveness, or comparative effectiveness of treatments or management strategies to improve pain care and reduce risk of addiction.

Q: Is a letter of intent required?
A letter of intent is desired, but not required.  Letters of intent are helpful for NIH staff, as they allow us to better manage the workload involved in reviewing applications.  They also help program staff try to ensure that your application will be responsive to the RFA. Letters of intent should be sent to Linda Porter at porterl@ninds.nih.gov

Q. Who should I contact if I have questions about information in the RFA?
You should contact Linda Porter for questions on the NOFO at porterl@ninds.nih.gov or 301-451-4460. See the contact list on this webpage for questions on the network and NIH institute or center (IC) specific questions.

Q. Should I contact NIH program staff before I apply?
Applicants are encouraged to contact the program officer at the institute whose mission aligns best with your proposal. It is always a good idea to speak with the Program Director at the IC where your application seems a best fit to inquire about their level of interest.  See the contact list on this webpage.

Q. To which institute will my application be assigned?
All applications initially will be assigned to the National Institute of Neurological Disorders and Stroke (NINDS).  They will be transferred if and when approved for an award to the IC whose interests are best aligned with your application.  The grant will be administered by this assigned IC.

Q. Can foreign institutions submit proposals?
No, all applicant institutions and study sites must be domestic. 

Q. Are foreign components, as defined in the NIH Grants Policy Statement, allowed?
No, foreign components are not allowed.

Q. Should I contact the Trial Innovation Network (TIN) Centers before I apply?
You should NOT contact the Trial Innovation Network awardees regarding their level of interest in your application or its content. They cannot provide consultation to applicants. You do not need to set up an agreement with the TIN coordinating centers prior to submitting your application. 

The NCATS Trial Innovation Network Centers will serve as clinical, biostatistical, and recruitment centers for the NIH HEAL pain management effectiveness research clinical trials. The services provided by the TIN are outlined on this webpage.

Q. How do I find CTSA sites for my study?
A list of HEAL Points of Contact at the individual CTSA institutions can be found at https://trialinnovationnetwork.org/heal-pain-ern-other-heal-foas/

They will help you find a local principal investigator, if available for your pain trial application at the clinical sites. 

Q.  What information do I need from the clinical sites who agree to participate in my study?
Sites within the CTSA consortium, outside the consortium, or in other, non-consortium networks can be included in the trial.  As per the he NOFO, applicants should state how many sites will be needed and survey the potential clinical sites to ensure that study recruitment targets can be met. Include the survey results in the application. The survey questions will depend on the nature of the trial and the protocol-specified screening procedures and might include availability of needed resources, number of eligible patients seen monthly, and projected enrollment.  Include a description of how additional clinical sites, not named in the application, will be selected to implement the trial.  The plan also should include a contingency plan for adding new sites if enrollment falls behind targets or discontinuing enrollment of new participants at sites that do not meet individual goals.

Q.  Where can I find more information about the TIN central IRBs?
Please see https://trialinnovationnetwork.org/elements/central-irb/ for more information about the TIN central IRB and the process of central IRB review.

Q.  Where can I find more information about the Master Clinical Trial Agreement?
Please see https://trialinnovationnetwork.org/elements/fdp-ctsa-trial-innovation-standard-agreement/ for more information about the Master Clinical Trial Agreement that will be used to pay the sites for each enrolled participants.

Q. Will awardees through this RFA collaborate with those from other NIH HEAL Initiative projects?
Yes, we expect that investigators who perform clinical trials will work collaboratively through a consortium within the ERN and across other NIH HEAL Initiative clinical trial networks to standardize data elements, pain assessments, study endpoints and outcomes as appropriate.   Data from all NIH HEAL Initiative clinical trials will be stored in a central repository.

Q. What are “U” grants and how do they differ from R01s?
This RFA uses the cooperative agreement funding mechanism which is a “U” mechanism. A cooperative agreement supports discrete, specified, circumscribed projects to be performed by investigators in an area representing their specific interest and competencies and is used when substantial and continuous NIH programmatic involvement is anticipated.

Q. Can NIH intramural investigators apply to this RFA or participate in the study as co-investigators?
Yes, although the requests by NIH intramural scientists will be limited to the incremental costs required for participation. These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses.  Participation should be approved by the relevant IC’s scientific or clinical director.

Q. Can I be a Principal Investigator on an application for one NOFO and also be a PI or multi-PI on an application submitted to another NOFO?
Yes, however, your participation as a PI is limited by your available percent effort.

Q. Will the applications submitted to all the NOFOs be reviewed in one study section?
Applications will be reviewed in an appropriate special emphasis panel with necessary expertise.

Q. What are the plans for data and resource sharing for this program?
Data from all awards will be submitted and stored in a central NIH-HEAL Initiative pain data repository.  See the RFA for more details about data sharing requirements. 

Q. Can NIH provide additional guidance on including milestones in the application?
Milestones are intermediate steps towards the completion of concrete goals and must include clear and quantitative criteria for success. Yearly quantitative milestones are required to provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years. The application must include clearly-specified, well-defined milestones, quantitative go/no go decision points, and timelines for assessing progress.

Applicants must provide a timeline and detailed quantitative annual milestones spanning the funding period. If selected for funding, applicants will work with NIH staff to develop more granular quarterly milestones for each year of funding. 

Q. What are some examples of quantitative milestones?
Examples of quantitative milestones include, but are not limited to, enrollment numbers, completion of enrolled patient follow up, and data deposition into the DIRC. Note that prior to an award, NIH staff and the applicants will finalize an agreed upon set of milestones that will be included in the notice of grant award.

Q. What types of clinical trials are considered responsive?
Trials that are designed to test and compare the benefits and harms of different interventions and strategies, for which efficacy is established to prevent and treat pain conditions in “real world” settings.

Study designs that that propose testing of interventions to establish initial efficacy of drugs, devices or biologics for approval by the FDA are NOT responsive to this NOFO.  They may be appropriate for the of the NIH HEAL Initiative EPPIC network – see EPPIC description on this information page.  

Studies to integrate interventions into health care systems or implement health care systems change may be appropriate for the NIH HEAL Initiative PRISM program. See the PRISM description on this information page.  

Q. Does my study design meet your criteria as an effectiveness trial?
Refer to the definition of effectiveness research in the NOFO and design your study in the context of this definition.  You should ensure that your control arm is justified.

Q. What other opportunities are available for clinical studies on pain.
There are other networks that support clinical studies on pain.  See the brief descriptions and links to other research networks on this information page.

Q. What must my application contain to be considered responsive?
Applicants must describe their research plans which must include a timeline, detailed qualitative milestones, and a data sharing plan.  Applicants should include their qualifications and should describe how the project will be managed. Please be sure to read the RFA thoroughly to ensure that all points have been addressed. In addition, applicants should be sure to address all the key points that are specific to this RFA in order to be responsive. Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review (CSR) and responsiveness by program staff of the trans-NIH working group. 

Q: I am a pain researcher who’s not doing clinical research and would be interested in being a part of a larger group of PIs on an application, could you facilitate making these connections?
A: NIH staff unfortunately cannot facilitate connections among applicants, because applicant information is confidential.   However, PIs are welcome to network to find other researchers interested in collaboration.  In addition, PIs may consider contacting their local CTSA and conducting PubMed or NIH Reporter searches to find other researchers with relevant expertise.

Q: Do you have some idea how many awards will be made through this RFA?
Funds are available to make approximately five awards in fiscal year 2019.

Q: For the budget, is the dollar amount listed on the NOFO direct only, or direct plus indirect?
The budget listed on the NOFO is total cost (direct plus indirect) for the NOFO.  Please note that the planning year will have a lower budget than the other years.  If the milestones from the planning year are met and the project is approved to move forward, then the budgets can be scaled up in subsequent years.

Q: Do applicants to this RFA need to fill out human subjects and biohazard sections?
Yes, if the applicant proposes use of human subjects and biohazards. Delayed human subjects reporting is not acceptable.

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