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NCCAM R34 Pre-Application Teleconference

Questions and Answers (August 5, 2010)

NCCAM Funding Announcement: PAR-10-163 Preliminary Clinical Studies in Preparation for Large Interventional Trials of Complementary and Alternative Medicine (CAM) Therapies (R34).

Purpose of Teleconference: On August 5, 2010, the National Center for Complementary and Alternative Medicine (NCCAM) convened a pre-application teleconference to provide technical assistance to prospective applicants. The teleconference provided an overview of the research program and a discussion of the grant mechanism used, information on preparing an application, and highlights of the review process. It also addressed participant questions.

Important information provided by NCCAM and specific questions and answers asked during the teleconference appear below.

Important information provided by NCCAM about the R34 PAR-10-163:

  • Applications for clinical trials may not do well in review due to lack of justification for intervention dose, frequency or duration of intervention, or validation outcome measures or biomarkers, etc.
  • The R34 is to provide funding for earlier clinical studies to ensure that the subsequent applications for larger studies will have adequate justification and preliminary data.
  • R34 applications include only human research; basic science or pre-clinical studies are not appropriate for this announcement.
  • Applications will only be accepted in focused NCCAM priority areas—a priority list is available on the Web site (nccam.nih.gov/grants/r34/priorities/).
  • Randomized controlled trials with a goal of establishing efficacy or effectiveness are not appropriate for this funding mechanism; however, it is expected that the results of these early preliminary studies may lead to a larger study with the primary aim of efficacy or effectiveness.
  • Principal investigators must receive NCCAM permission to apply for the R34. The materials necessary for the “permission to apply” process are available on the Web site and are referred to in the FOA Section 3.3 (nccam.nih.gov/grants/r34/letter/). The materials must be submitted 8 weeks before the applicant’s planned receipt date. Materials for the October 16, 2010, receipt date must be submitted by August 20, 2010.
  • The “permission to apply” materials can be sent to Dr. Wendy Weber via e-mail as an attachment or by regular mail (weberwj@mail.nih.gov).
  • The R34 applications will be reviewed by a Special Emphasis Panel, established by the NCCAM Office of Scientific Review. The panel will reflect the nature and purpose of the applications that are accepted for review.
  • R34 projects can be for up to 3 years duration and $450,000 direct costs. The indirect costs of subcontracts do not count toward the direct costs.
  • The funding announcement allows for an optional administrative period of up to 1 year and $100,000 direct costs, which could be used to finalize IRBs, IND, DSMP, creation of a manual for the study protocol, etc.
  • Applicants should ask themselves what data is needed to justify a larger clinical study. What is needed or missing to get a larger clinical study funded in the priority areas identified by NCCAM for this funding opportunity?
Request for Permission to Apply Due Planned Application Receipt Date
December 22, 2010 February 16, 2011 (new)
March 11, 2011 May 7, 2011 (HIV/AIDS applications)
April 21, 2011 June 16, 2011 (new)
May 20, 2011 July 16, 2011 (resubmission)
July 13, 2011 September 7, 2011 (HIV/AIDS applications)
August 19, 2011 October 16, 2011 (new)
September 21, 2011 November 16, 2011
November 11, 2011 January 7, 2012 (HIV/AIDS applications)

Teleconference Participants’ Questions and Answers

Questions are categorized in the following four topic areas (click on the topic area below to go directly to the questions on that topic):

  1. General Questions
  2. Grant Mechanism Questions
  3. Study Design Questions
  4. CAM Therapies Questions

General Questions

Q: Can an applicant send in two applications?
A: Technically, yes; but the applications would be competing against each other for funding since there will only be one review panel.

Q: If an Investigational New Drug (IND) is appropriate for a proposed study, should applicants apply for it during the administrative period? If an applicant already holds an IND for an intervention for a different population/disease/clinical indication, can the applicant get an amendment as opposed to reapplying?
A: Applicants should contact the U.S. Food and Drug Administration (FDA) to determine if an IND would be accepted for review for the protocol they are proposing. Applicants should include whether they have an IND or are required to get an IND in the “permission to apply” materials. If an applicant has an IND for one clinical application, an amendment may not suffice for another study. Applicants should contact the FDA to determine what is necessary. The NCCAM program contact for probiotic studies and IND issues for these studies is Dr. Linda Duffy (duffyl@mail.nih.gov). Please contact her with specific questions about the IND requirements for probiotics.

Q: Will applicants receive feedback on the “permission to apply” submissions?
A: Applicants will be notified whether or not they have permission to apply for an R34 by letter. The committee will review the materials and provide feedback before the receipt date for the full application. Applicants are encouraged to continue working on their full application while the “permission to apply” materials are being reviewed.

Q: Will the Special Emphasis Panel review roster be available before the application deadline?
A: No. The review panel will be selected based on the applications that come in.

Q: How many applications will be funded and for how many funding cycles will applications be accepted?
A: The announcement expires in 2013. Applications will be accepted at the standard receipt dates (October 16, February 16, and June 16 for new applications). Revised applications should use the standard receipt dates for revised applications. The funding of applications will be based on merit, available funds, and NCCAM priorities.

Q: Can I send proposed specific aims to Dr. Weber for review before submitting my permission to apply?
A: Yes, but the final package of “permission to apply” materials must be submitted at least 8 weeks prior to the receipt date you are planning to use.

Q: Can I revise my permission to apply materials?
A: Yes, if you have already sent materials to Dr. Weber or to another Program Officer and would like to revise them, please send the revised materials via e-mail to Dr. Weber by the due date.

Topic Areas

Grant Mechanism Questions

Q: What mechanism follows an R34?
A: Most likely an R01. The R34 study should provide preliminary data for a larger clinical study or the next appropriate stage of research, which in most cases would be an R01.

Q: Is NCCAM signed on to the NIH Parent R34?
A: No, NCCAM is not participating in the NIH Parent R34. NCCAM has its own R34 (PAR-10-163) and is only accepting applications for the NCCAM-specific priority areas noted in the announcement. (nccam.nih.gov/grants/r34/priorities/).

Q: Is NCCAM still accepting R21s?
A: NCCAM is currently signed onto the NIH Parent R21 for investigator-initiated exploratory/developmental research (PA-10-069). This funding opportunity provides up to 2 years of funding and up to $275,000 direct costs. The NCCAM-specific R21 funding for clinical studies (PAR-08-135) has expired.

Q: Can the R34 mechanism be used to standardize a protocol?
A: An applicant can use the 1-year planning period to standardize a protocol, but a clinical study must be done as part of the R34 grant.

Q: The process seems different than a typical Letter of Intent because people can be denied permission to apply. What criteria is NCCAM using to accept or not accept studies?
A: This is a “permission to apply” process, not a letter of intent. The main criteria are: studies must fall in the NCCAM-specific priority areas and must not be a randomized control trial. There must also be adequate justification for a subsequent larger study.

Topic Areas

Study Design Questions

Q: What kind of population is NCCAM interested in for mind-body studies?
A: This is up to the applicant. Applicants should justify the population they plan to use.

Q: If RCTs are not allowed, how do you establish an intervention without using efficacy or effectiveness?
A: The R34 project will fund the preliminary studies necessary to better plan a larger clinical study that would determine the efficacy or effectiveness of an intervention. Prior to designing an RCT investigators need to have preliminary data to justify the study, such as the choice of intervention, dose or frequency and duration of intervention, selection of appropriate valid outcome measures, feasibility of recruitment of study population, and the adherence to the proposed intervention.

Q: Can I propose my mind-body study in a disease population?
A: As long as the applicant’s project remains within the priority areas identified by NCCAM, the study could be conducted in a population of patients with a specific disease. The investigator needs to provide justification for the sample population to be used.

Q: Do we need to include a placebo arm to a proposed study?
A: Placebo-controlled trials are not appropriate for the R34 funding mechanism.

Q: Will the results of the preliminary studies conducted under the R34 ultimately lead to efficacy studies?
A: The results of the R34 studies could lead to larger efficacy or effectiveness trials.

Q: Is NCCAM interested in a project studying the mechanism for identifying responders or selecting patients?
A: Yes. NCCAM is potentially interested in identifying who responds to a given intervention. Validation of a new biomarker or questionnaire to identify responders could be proposed as long as it fits within NCCAM’s priority areas.

Q: For proposed probiotic studies, is NCCAM looking for biomarker studies or dose studies? Does an application have to include both?
A: This is up to the applicant. One or the other or both could be proposed. Applicants need to propose what can be completed within the timeframe and funds available with this mechanism.

Q: Do you have dosing recommendations for probiotic studies?
A: Please contact Dr. Duffy (duffyl@mail.nih.gov), the NCCAM program officer for the probiotics portfolio to discuss specific science questions related to probiotics. RCTs are not appropriate for this mechanism. However, applicants can randomize patients to different doses or different timing of doses.

Q: It was mentioned that validating outcome measures would be acceptable under the R34. Does neuroimaging count?
A: Applicants can propose imaging studies, but applicants will need to justify how the imaging will be used as an outcome marker in a larger clinical study and why it is ready to be used/validated as a biomarker. Studies aiming to explore the neuro-mechanisms of CAM approaches are not appropriate for this funding opportunity.

Q: Will a study investigating low back pain in pregnant women be accepted?
A: There is only one priority area dealing with back pain, and it is the use of devil’s claw (Harpagophytum procumbens). Applicants would need to justify the safety of this treatment in pregnant women and discuss the need for an IND application with the FDA.

Q: Can feasibility be part of an R34 application?
A: Yes, NCCAM is accepting feasibility studies for this funding opportunity. This is especially needed when applicants are proposing to use an intervention in a new population or a group of patients with a specific disease.

Q: What kind of study design is NCCAM looking for? Do only observational studies apply?
A: For this funding opportunity, NCCAM is looking for early phase clinical studies and not randomized controlled trials to assess efficacy or effectiveness. Prospective observational studies are appropriate. The applicant will need to select the appropriate design based on the aims of the study and justify their choice of design.

Topic Areas

CAM Therapies Questions

Q: Are health behaviors the priority area of interest for mind-body interventions?
A: Yes, for this funding opportunity, the health behaviors listed are a priority. NCCAM is not looking for mindbody interventions to treat or mitigate a specific disease.

Q: What if the proposed study combines a mind-body intervention with another intervention? Is this acceptable for the R34? Does the intervention need to be well established?
A: The applicant must provide a strong justification for adding the mind-body intervention to something that already exists and why the mind-body intervention should be studied in the context of the other intervention.

Q: Does NCCAM fund spiritual care for patient’s being studied?
Q: Would an application for a therapeutic for autism fit the announcement? It is a mind-body intervention.
Q: Does massage fit into the announcement?
Q: Would a project studying acupuncture for pain be accepted. Is acupuncture considered a mind-body intervention?

A: NCCAM does fund other areas of research via other funding mechanisms. For other funding opportunities please look on the NCCAM Grants and Funding Web page. For this funding opportunity (PAR-10-163), NCCAM is only accepting applications in the priority areas that are listed on the Web site (nccam.nih.gov/grants/r34/priorities/). If the area of research you want to pursue is not on this list, you need to use a different funding mechanism.

Q: What does NCCAM consider mind-body interventions? Does neurofeedback apply to this announcement?
A: For this program announcement, NCCAM is looking for studies using yoga, mindfulness, tai chi and qi gong. Neurofeedback may be appropriate depending on the proposed study. Materials for the permission to apply should be submitted, and the committee will let applicants know relatively quickly if the studies are within NCCAM’s priority areas.

Q: Weight maintenance is mentioned in one of the priority areas. Does this include the initial weight loss period as well?
A: NCCAM is interested in maintaining weight loss. Proposed studies for the R34 looking at the initial weight loss period should also include weight loss maintenance as part of the followup.

Q: Will studies comparing two types of mind-body interventions be accepted?
A: Because this funding opportunity is for preliminary clinical studies, the study could not propose to determine the superiority of one mind-body therapy to another. If the applicant was proposing to look at adherence or feasibility of the two interventions to determine which to use in a larger trial, for example, this would be appropriate for the funding opporutnity.

Q: Mindfulness is listed as one of the mind-body interventions in the funding announcement. Is this only mindfulness meditation or do other types of meditation fit the announcement?
A: Other types of meditation that contain a mindfulness component and fit the priority areas of the announcement would be appropriate.

Topic Areas


For additional programmatic questions about this funding opportunity, please contact:

Wendy Weber, N.D., Ph.D., M.P.H.
Program Director
Division of Extramural Research
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892-5475 (for express delivery, use 20817)
Telephone: 301-402-1272
Fax: 301-480-1587
E-mail: weberwj@mail.nih.gov