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National Center for Complementary and Integrative Health

Technical Assistance Webinar for NCCIH’s New Approach to Mind/Body Funding Opportunities

August 5, 2021

Purpose of the Webinar

On Thursday, August 5, 2021, the National Center for Complementary and Integrative Health (NCCIH) of the National Institutes of Health hosted a technical assistance webinar to share information about the updated NCCIH Framework for Clinical Research and new priorities for the NCCIH’s clinical research portfolio. Several new funding opportunity announcements (FOAs) were discussed.

Webinar Speakers and Panelists

  • Wendy J. Weber, N.D., Ph.D., M.P.H., Branch Chief, Clinical Research in Complementary and Integrative Health Branch, Division of Extramural Research, NCCIH
  • Sushmita Purkayastha, Ph.D., Scientific Review Officer, Office of Scientific Review, NCCIH
  • Dave Clark, Dr.P.H., Program Director, Clinical Research in Complementary and Integrative Health Branch, Division of Extramural Research, NCCIH
  • Lanay M. Mudd, Ph.D., Program Director, Clinical Research in Complementary and Integrative Health Branch, Division of Extramural Research, NCCIH
  • Della White, Ph.D., Program Director, Clinical Research in Complementary and Integrative Health Branch, Division of Extramural Research, NCCIH
  • Anita McRae-Williams, M.A., Outreach Communications Program Manager, Division of Extramural Research, NCCIH (Webinar Moderator)

Program Perspective

Dr. Weber explained that NCCIH’s framework for clinical research related to mind and body interventions was updated in the Center’s recently released strategic plan for fiscal years 2021 to 2025.

The previous framework included five stages of research, beginning with basic and mechanistic research and extending through translational research, intervention refinement, efficacy/effectiveness studies, and pragmatic studies and dissemination. The new framework includes six stages, with dissemination and implementation science (studies to determine how to facilitate uptake of an effective intervention in various settings) highlighted as the final stage. NCCIH funds human research across the entire continuum, but today’s webinar focuses on the third through sixth stages of the new framework (intervention refinement and optimization; efficacy; effectiveness and pragmatic studies; and dissemination and implementation science).

Evaluation of NCCIH’s Previous Mind and Body FOAs

NCCIH has had FOAs for mind and body interventions for several years. Recently, the Center evaluated these FOAs to determine what was working well and what had proven to be a challenge.

Features of the funding opportunities that have worked well included:

  • Peer reviews by a special emphasis panel that understands the stages of research for each FOA as well as issues specific to mind and body approaches
  • Special review criteria in the FOAs that allow reviewers to provide feedback relevant to the specific stage of research
  • Multiple mechanisms for different stages of research:
    • R34 for feasibility trials
    • U01 for multisite feasibility trials
    • UG3/UH3 and U24 for multisite efficacy, effectiveness, or pragmatic trials, with an independent data coordinating center

Challenges that needed to be addressed in the updated FOAs included:

  • The timeline from feasibility trials to efficacy/effectiveness trials was too long.
  • Perhaps reflecting the long timeline, NCCIH has supported many feasibility studies and few efficacy trials, and few applications for efficacy and effectiveness multisite trials have been submitted.
  • Preliminary data requirements in the old FOAs required investigators to replicate published feasibility trials.
  • The old FOAs placed a strong emphasis on adaptive designs, which may have discouraged investigators from proposing straightforward randomized controlled trials even when they would be the most efficient design to answer the research question. The updated FOAs clarify when adaptive designs are the best fit.

The new FOAs streamline the timeline and cost to get to impactful clinical trial results, while still providing multiple entry points into NCCIH’s framework for clinical research, depending on the level of evidence for an intervention in a specific patient population. They decrease the need for repetitive single-site feasibility trials by addressing preliminary data requirements that were too strict, allowing investigators to leverage pilot studies with similar interventions and similar patient populations. The new FOAs prioritize impactful, large-scale clinical trials. In fact, NCCIH plans to identify high-priority areas for large-scale (UG3/UH3 and U24) trials and will periodically call for applications.

Revisions to the Mind and Body R34 (PAR-21-240)

No changes have been made in the preliminary data requirements (no preliminary data are required), budget ($450K total), or duration (up to 3 years) in the R34. However, the scope has changed.

Previously, NCCIH expected investigators to use the R34 to conduct pilot studies to gain experience with the exact intervention and patient population they would like to study in a larger trial. The new scope is intended more specifically for situations when no feasibility or acceptability work on the same or a similar intervention has been done in a similar population. The R34 is also suitable for developing standardized treatment protocols for multicomponent interventions and for situations where substantial adaptation or tailoring of an intervention is needed before a larger trial can be conducted.

Updates to the R01 (Formerly U01) for Multisite Feasibility Studies (PAR-21-241)

Major changes have been made to the FOA for multisite feasibility studies. The previous scope of this FOA involved multisite feasibility trials for all interventions, with an emphasis on adaptive designs or dose-effect trials. The emphasis on this has now been reduced. The new FOA calls for multisite feasibility work at two or more sites when this has not previously been done in the literature. It also allows investigators to make minor intervention adaptations at this stage to enhance fidelity or adherence, rather than having to use the R34 mechanism for this purpose.

The requirement that the investigative team must have done a pilot of the specific intervention in the specific population has been removed. Instead, preliminary data on similar interventions and similar clinical populations are considered acceptable. For example, an applicant proposing a trial of one type of yoga might cite data from an otherwise similar study of a different type of yoga in the same population. In addition, the collective experience of the team with similar studies can be considered. For example, a team proposing a yoga study could cite team members’ experience with other types of physical activity studies or with similar though not identical populations.

The funding mechanism has been changed from a U01 cooperative agreement to an R01 research project grant, which gives investigators a little more freedom. The budget has been decreased from $500K to $350K and the duration from 5 years to 3 years, but NCCIH recognizes that there may be some situations where a longer duration is needed, for example if relatively lengthy follow-up data are to be collected. However, in general, the goal is to move quickly and efficiently through this phase.

Updates to the Mind and Body UG3/UH3 (PAR-21-243) and U24 (PAR-21-242)

As with the previous FOAs, these FOAs are for multisite efficacy, effectiveness, or pragmatic trials, and a set of applications for a clinical coordinating center and independent data coordinating center are required. The new scope specifies a requirement for three geographically distinct sites for generalizability and a requirement for 90 percent power for the primary outcome. The FOA clarifies that the 1-year planning phase includes a requirement for a transition request to be submitted in month 9 and that investigators should use the design that best assesses their primary hypothesis, regardless of whether this is a standard randomized controlled trial or an adaptive design. A vanguard or run-through pilot study in the planning phase is permitted.

The requirement that the investigative team must have done a multisite pilot of the specific intervention in the specific population has been removed. The required preliminary intervention data and collective experience may involve similar interventions and similar populations. NCCIH is also looking for the collective team’s experience in successfully completing and publishing previous trials.

No changes have been made to the funding mechanism or budget. NCCIH expects that most applications will have direct costs from the UG3/UH3 and U24 combined greater than $500K per year and therefore will trigger the requirement to obtain permission to apply. The duration has not changed. A 1-year planning period followed by a 4-year trial is expected, and a trial of up to 6 years is allowed when a long follow-up period is needed.

Other Funding Opportunities

Dr. Weber mentioned two other funding opportunities for clinical research:

  • NCCIH has an mHealth R01 (PAR-20-154) for fully remote studies of remotely delivered interventions in NCCIH high-priority areas. The interventions studied could be phone-based or web-based or involve wearable or other devices. The FOA has details about the preliminary data requirements.
  • NCCIH participates in the National Institutes of Health (NIH) dissemination and implementation research in health R01 (PAR-19-274) and recommends using it for hybrid type 3 effectiveness-implementation trials. For hybrid type 1 and type 2 trials, the UG3/UH3 and U24 funding mechanism is a better fit. There is also an R21 dissemination and implementation FOA (PAR-19-275).

Summary of Changes to the Clinical Research FOAs

In summary, Dr. Weber explained that the key changes to the mind and body clinical research FOAs involve:

  • Updating preliminary data requirements
    • Removing the requirement to repeat similar feasibility trials
    • Allowing investigators to cite literature about similar interventions
  • Allowing investigators to cite the collective experience of their team
  • Streamlining the pipeline of clinical trials by offering multiple FOAs with shorter timelines
  • Prioritizing impactful fully powered clinical trials

Review Perspective

Dr. Purkayastha provided a perspective on key factors in the review of applications submitted in response to the mind and body clinical research FOAs. She cautioned that applications that are nonresponsive to the FOA, noncompliant, or incomplete may not be accepted for review.

  • To ensure that an application is responsive, applicants should look for “must,” “need,” and “required activities” when reading through the Scope and Responsiveness Criteria and address all of them.
  • Compliance requirements—including requirements for budget, project period, and whether foreign components are allowed—differ among the FOAs. Preapproval is required if the combined budget of a UG3/UH3 and U24 exceeds $500K in any year. Foreign components are not allowed in applications submitted under the R34.
  • To ensure an application is complete, applicants should make sure all required attachments are included. Applications for all the clinical trial FOAs must include a clinical trial experience table. Some of the FOAs also require a milestone plan and project management plan.

Post-submission materials are allowed and are due 30 calendar days before the peer review meeting date. Allowable post-submission materials include an updated clinical trial experience table and revised milestone or project management plans. Information accidentally left out of the application cannot be submitted as post-submission material.

Applications will be scored based on the five standard review criteria (significance, investigator[s], innovation, approach, environment). Additional review criteria will also be considered and will affect the overall impact score. Additional FOA-specific language has been added to the standard review criteria for all the FOAs. Reviewers are instructed to address the same topics that applicants are asked to address in their applications. Applicants should make sure to read and take into consideration the review criteria.

Applications submitted in response to any of these FOAs will be reviewed in a special emphasis panel at NCCIH. Reviewers will be selected based on their specific expertise in the target areas of the FOA and the science proposed in the applications. Reviewers will be oriented to use the additional review criteria and the additional review language added to the standard criteria in their assessments.

Applicants should pay close attention to important dates related to their application, including:

  • The date for submitting a letter of intent (30 days before the application due date; submission is encouraged but not required)
  • The application due date
  • The 2-week late submission window (details about when late submissions are permitted can be found in NOT-OD-15-039)
  • The due date for post-submission materials (30 calendar days before the peer review meeting date, see NOT-OD-19-083)

Questions and Answers

At this point, Ms. McRae-Williams opened up the meeting to participant questions, which were answered by members of the panel.

Q: Can you please comment on what qualities you are looking for in meditation-related applications in efficacy as well as mechanistic studies?

A: Dr. Weber explained that NCCIH supports both efficacy and mechanistic studies and asks individuals to clearly describe the type of meditation they are studying. For mechanistic studies, it is best to contact a program director from the Basic and Mechanistic Research Branch within the Division of Extramural Research. Applicants who have a set of specific aims prepared should reach out to a member of the NCCIH program staff to discuss their planned study.

Q: Please help us to understand the relationship between the multiple R01 and some of the more focal Notices of Special Interest (NOSIs) that use the parent R01.

A: Dr. Clark explained that the purpose of the multisite R01 that Dr. Weber discussed is to demonstrate feasibility in preparation for a fully powered efficacy study. NCCIH does offer NOSIs, for example one on adherence, that use the parent R01 mechanism. Sometimes generalizability can be addressed sufficiently at single sites in these cases. Dr. White added that all NOSIs in which NCCIH participates include a list of the types of applications NCCIH is looking for. Dr. Weber explained that NOSIs are published when there is a particular area of science NCCIH wants to draw applicants’ attention to. NOSIs use existing FOAs.

Q: Which guidelines apply to dietary supplement research?

A: Dr. Weber explained that NCCIH has a suite of FOAs for natural products research like the suite of FOAs for mind and body research discussed during this webinar. As with the mind and body FOAs, the natural products FOAs include FOAs for both pilot studies and multisite efficacy/effectiveness trials. Dr. Weber is usually the contact person on the natural product FOAs, and potential applicants can email her with specific questions.

Q: What if you are currently performing a standard RCT efficacy trial at one site? Can you apply for a UG3/UH3? Or is there something else that would need to be done, maybe during the UG3 phase?

A: Dr. Mudd explained that one of the reasons for the UG3/UH3 and U24 mechanism is to enhance the generalizability of findings. This may be particularly relevant for mind and body interventions that are delivered by a single person. Multisite designs can avoid potential bias due to a single site and interventionist, where results could be affected by the specific person who delivers the intervention. Therefore, NCCIH wants to support multisite work. If you are doing a single-site study, you could consider how a later multisite trial would add to the body of evidence.

Q: Ms. McRae-Williams said that a very specific question about trials of remotely delivered interventions would need to be addressed by a program director.

A: Dr. Mudd, who is the contact person for the FOA in question, said that the questioner should email her directly. A second question about the funding opportunity for remote research was also referred to Dr. Mudd.

Q: What are hybrid type 1, 2, and 3 designs?

A: Dr. Clark explained that hybrid designs involve outcomes that relate to both effectiveness and implementation. Hybrid type 1 studies are predominantly focused on effectiveness but begin to look at implementation. Hybrid type 2 studies have equally important effectiveness and implementation aims. Hybrid type 3 studies are predominantly focused on implementation but also collect some effectiveness data.

Q: Do the pilot data required for the R01 related to collective team experience need to be of the team working together or could it relate to individual team members’ experience?

A: Dr. White replied that for the R01, NCCIH is looking for the contribution of each team member’s experience to the collective. For example, the group needs to include someone with experience running trials in the specific population to be studied, such as children or a diverse population. Data from the literature can also be cited to support feasibility, in addition to the experience of the research team.

Q: Can a study recruit participants internationally if the intervention is provided through technology by investigators located in the United States?

A: Dr. Mudd said this would need to be considered on a case-by-case basis. In general, NCCIH does not support clinical trial work outside the United States and Canada because of the need to provide oversight. If the investigators are in the United States and participants are all over the world, relevant issues would include local laws and privacy issues and how the data are flowing. Dr. Clark added that for the R34, it may be relevant that foreign components are not allowed, but a conversation about this topic would still be needed.

Q: Are interventions for pain management appropriate for these mind and body FOAs?

A: Dr. Weber explained that they would be appropriate if the intervention includes a complementary and integrative health approach. NCCIH does not fund pharmaceutical trials.

Q: Will the webinar be available later as a recording for people who missed seeing it live?

A: Ms. McRae-Williams explained that a recording would not be made available, but all registrants, including those who did not attend, will receive a summary of the webinar and the webinar slides by email in about 10 days.

Q: How do you get in touch with a program officer?

A: Contact information is available on the NCCIH website, in the section on the Division of Extramural Research. You could also search for the names of any of the presenters at this webinar.

Q: Do you have concerns with meeting recruitment goals in the new reduced 3-year R01 FOAs?

A: Dr. White explained that NCCIH wants to speed up the timeline of research, which probably means paring down some projects from what was done with the old U01. Some applications may need to be for longer than 3 years for longer follow up. However, in general, NCCIH wants applications pared down to just what is necessary to establish retention, adherence, and fidelity before moving forward to an efficacy or effectiveness trial.

Q: What type of qualifications does an investigator need to host a clinical trial?

A: Dr. Weber explained that technically, anyone can apply for a research grant from NIH. However, researchers are looking for a track record of conducting research or working in an environment that supports clinical research. Many investigators are clinicians or scientists, but NCCIH also gets applications from others, including small businesses. Dr. Weber recommended contacting one of the NCCIH program staff for further information.

Q: What is the distinction between efficacy, effectiveness, and pragmatic trials for self-guided mobile health interventions?

A: Dr. Mudd explained that in general, efficacy refers to trials conducted under tightly controlled circumstances, effectiveness refers to trials conducted under more usual circumstances, and pragmatic refers to trials conducted in a health care setting. For remotely delivered interventions, the lines are a little more blurred, but the inclusion/exclusion criteria for the study are informative. They are usually much stricter in efficacy trials than effectiveness or pragmatic trials.

Q: Can you clarify the difference between an R21 and an R34?

A: Dr. Weber said that an R21 is typically 2 years and has a smaller budget, typically around $275K over those 2 years. The specific R34 FOA discussed here is for 3 years and has a larger budget. Dr. Weber cautioned that different NIH Institutes and Centers use these funding mechanisms differently, so it is important to check the details in each FOA.

Q: Does the multisite R01 require two geographically different locations?

A: Dr. White said that it does.

Q: What criteria need to be fulfilled for using an herbal supplement manufactured in a non-U.S. facility?

A: Dr. Weber recommended consulting the natural product integrity policy on the NCCIH website for details. Research of this type typically requires an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). Ms. McRae-Williams recommended consulting NCCIH’s Natural Products Clinical Trials Resource, which explains FDA requirements for natural products clinical trials research.

Q: For the R01, are two sites within the same state acceptable?

A: Dr. White explained that NCCIH would like to see opportunities to improve generalizability in multisite feasibility trials. There is less diversity within a state than across multiple states. Also, investigators need to get experience running trials across geographically separated sites and recruiting dissimilar populations while doing a feasibility trial so they will be prepared for a fully powered multisite efficacy trial.

Q: Does the U24 need to be independent from the investigative team, or is it embedded in the investigative team?

A: Dr. Mudd explained that the U24 is a companion funding opportunity to the UG3/UH3. The two applications should have distinct principal investigators and distinct key personnel. The data coordinating center is critical to enhancing the integrity of data collection and the processing of data for a large multisite trial.

Q: Are the materials and guidelines for mind and body studies discussed here applicable to dietary supplement studies?

A: Dr. Weber explained that the framework discussed here was created for mind and body studies because nothing similar existed. For pharmaceuticals, there is a clear pipeline from Stage 1 to Stage 4 trials, and much of that structure applies to dietary supplements as well because they are also substances that have pharmacological activity in the body. There are important differences between mind and body interventions and pharmaceuticals/supplements. For example, adherence is harder to measure with mind and body interventions; it does not just involve a pill count. Assessing feasibility is also different; for example, can people do yoga every day? These differences are the reason why NCCIH created a framework specific to mind and body approaches.

Q: We recently submitted an application in response to an R34 that did not call for a clinical trial experience table, so we did not include one for fear the application would be rejected. Should we submit one as an update for review?

A: Dr. Purkayastha said that an update should be submitted.

Q: If you have done previous research on an intervention delivered in person and you want to look at remote delivery, would you use the R34 or the R01?

A: Dr. Mudd explained that it depends on whether you have experience with the remote delivery approach—or whether remote delivery of the intervention has been reported in the literature. The FOAs have specific requirements for preliminary data. You may need to establish the feasibility of remote delivery before proceeding with other aspects of your research.

Q: For a study of emotional freedom techniques (EFT), can published pilot studies demonstrating the effectiveness of the technique be cited for a larger multisite study? Also, is it an issue that one of the main researchers is in Australia?

A: Dr. Weber explained that it is possible to have a collaborator in another country, but there are many regulatory issues that make international research challenging. NCCIH is one of NIH’s smaller centers, and the cost for oversight of international research is high. If the pilot studies demonstrate feasibility with fidelity across sites and good adherence, they might meet all the preliminary data requirements, but it is important to check the requirements and make sure that all the necessary elements are included. A study of the type suggested here would probably exceed the $500K limit for direct costs in one year, so the investigators should be sure to obtain permission before submitting an application.

Q: Can you say a little more about NCCIH’s excitement for adaptive interventions and whether it has softened?

A: Dr. Weber explained that NCCIH is still very interested in adaptive designs if they fit the research question—such as a question about the order of interventions or which components of an intervention to retain or drop. The choice of study design should be based on the research question, rather than trying to fit a proposed study into an adaptive design.

Q: Could you talk about any diversity supplement opportunities that are available?

A: Dr. White explained that NCCIH participates in the NIH diversity supplement program. Dr. Mudd is the training officer. Ms. McRae-Williams suggested looking at the new section on diversity on NCCIH’s website.

Closing Remarks

Ms. McRae-Williams asked participants to look out for an email from her with the webinar slides and summary.

Dr. Weber said that one topic the panel did not get to was NCCIH’s priority areas. These are specified in each FOA. They are similar across the FOAs, but they have been updated. If an investigator has a set of specific aims, it is a good idea to share them with a member of NCCIH’s program staff to determine whether the funding mechanism you plan to apply for is appropriate and whether the proposed study is a good fit with NCCIH’s mission.

NCCIH staff provided the following additional answers to questions after the webinar had ended.

Q: What are the NCCIH-designated areas of high research priority—and where can we find those? Have they been updated?

A: The high-priority topics are outlined in each FOA. High-priority research areas are also described in the NCCIH strategic plan.

Q: We are looking into applying to the NOSI for interoception as a mechanism for EFT/tapping. Can you say something about how this might fit in with the current funding sources?

A: NOT-AT-21-002 points to the parent R01 and R21. To apply to that NOSI, you would need to use one of the funding opportunities linked to within the NOSI. Note that this NOSI calls for basic and mechanistic research and not clinical trials to test efficacy of interventions.

Q: Do you envision SMART designs being relevant to important clinical questions for the new UH PAs (Program Announcements)?

A: SMART (Sequential Multiple Assignment Randomized Trial) designs may be very relevant for the new FOAs. As we discussed, it is important to match the research design to the primary research question you want to address.

Q: Regarding remote delivery, do you know of NCCIH partners who are interested in making new cognitive embodiment programs that are delivery online available and focused on marginalized communities?

A: Please reach out directly to an NCCIH program director for further discussion of your research question. You may also wish to reach out to other NIH Institutes, Centers, and Offices where your research questions may be of interest. To be considered for NCCIH funding, research questions need to be relevant to the NCCIH mission.

Q: For the multisite R01, will there be an expectation to identify a mechanism of behavior change, e.g., self-regulation?

A: Applications to the NCCIH multisite R01 are not required to include measures of mechanisms of the intervention. In most circumstances investigators considering applying to the NCCIH multisite R01 are discouraged from including basic/mechanistic aims, as these aims would be better accomplished in an application focused on a mechanistic clinical trial. If the literature has identified a potential mechanism of the intervention, this information can be included in the application as preliminary data on the intervention.

As stated in the FOA:

“It is highly encouraged, although not required, that [preliminary data include]:

  • A similar intervention can produce a clinically meaningful change in a measurable biological signature or psychological process (e.g., mechanism of action) in a population similar to the one of interest. Additional evidence demonstrates that the change in biological signature or psychological process has been replicated in a separate human study with an intervention similar to the one to be used in the proposed trial.”

Q: For the new R01 multisite feasibility study, did I understand correctly that we can include co-investigators from outside of the United States and collect data from their country?

A: You may include co-investigators from outside of the United States, but all data must be collected in the United States or Canada (nccih.nih.gov/research/international-health-research).

Q: We are extending from one area of research to NCCIH-related funding. Is there a resource page for established investigators?

A: This webpage lists our active clinical trial funding opportunities with some resources. Please contact us directly for additional questions.

Q: Does NCCIH support studies involving FDA-cleared medical devices?

A: We may, depending on the device and research focus. Please contact a program director with a brief description of your research questions.

Q: I am interested in submitting an R34 to investigate acupuncture and acupressure self-care at home for chronic pain experienced by diverse midlife women. What is the status of clinical trials of acupuncture for chronic pain in specific populations? I understand clinical trials of acupuncture for chronic pain in a general sense are a low NCCIH priority. Are they fundable in a specific subpopulation with a high prevalence of chronic pain?

A: Please contact a program director for a more in-depth conversation.

Q: Two questions: 1) Can you share the percentage of research that you fund with these mechanisms that are school-based programs? 2) When you mention multiple sites, could this be schools in the same district with very different student populations?

A: We encourage you to review NCCIH-funded research publicly available at reporter.nih.gov to see the range of science NCCIH has supported in this space. We encourage investigators to propose geographically distinct sites, ideally in different regions of the country. Please contact a program director for a more in-depth conversation.

Q: How will you coach applicants to bring in applications with leaner budgets while keeping up with significance and performing a sufficiently powered and rigorous study?

A: Please note that the R01 mechanism (PAR-21-241) is not meant to support powered efficacy trials; it focuses on multisite feasibility instead. That is the funding opportunity where we are recommending a shorter timeline and budget. We will discuss budget with applicants on a one-on-one basis. Please contact a program director for a more in-depth conversation for a specific application.

Q: I am interested in the panelists’ thoughts about guided imagery and where it is positioned in complementary and integrative health approaches. This cognitive technique shares conceptual and practical similarities with mindful meditation and relaxation techniques, but it can also be a unique practice. I apologize if this is too specific for this webinar.

A: Please contact a program director for a more in-depth conversation about your research interests.

Q: Would happiness research be relevant for this R01? For example, correlation of physical activity, in working age and multiethnic adults and happiness?

A: Please contact a program director for a more in-depth conversation about your research interests. The funding mechanisms discussed in this webinar would not be appropriate for an observational/epidemiological study as they are specific to clinical trial development and testing.

Q: Could you speak to what you are looking for in terms of new investigators and the R34 mechanism?

A: We are looking for the same qualities that we look for from experienced investigators: high-quality, high-impact rigorous research. The R34 application review does not include any special considerations for NIH-defined new investigators. The standard review criteria and FOA-specific additional review criteria apply to “New Investigators” applying for the R34 mechanism.

Q: Addendum, happiness question/study: quant study single site: one university, two campuses (same state).

A: See response above.

Q: Must the preliminary data that support a UG3/UH3 application come from an NCCIH-sponsored R01? Or can data supported from other NIH projects qualify?

A: We have broadened the preliminary data requirements—data from other NIH projects or the published literature may be used in an application to the UG3/UH3 funding mechanism. Note that the clinical coordinating center application (UG3/UH3) must be submitted with a companion application for an independent data coordinating center (U24).