Questions for June-July 2010:
Q: What is the primary clinical focus of the Network? Is this for acute heart failure, chronic heart failure or both?
A: The clinical focus of the Network is heart failure – both acute and chronic.
Q: Is there an emphasis on therapeutic clinical trials? Or are the funding areas based on "novelty" of each submission and not necessarily a specific agenda? Will the research also focus on studying different approaches in acute heart failure (i.e. phenotype treatment) as much as different therapies?
A: The Network is designed to support smaller, proof of concept trials that can be completed within the budget period in a structure where several trials will be conducted concurrently. Large, definitive Phase III RCTs are beyond the scope of the Network, the purpose of which is to foster flexibility and allow the rapid start up and completion of a portfolio of studies across the field of heart failure. The scientific agenda of the Network will be set by the successful applicants, in part based on the scientific proposals in the applications, in part based on the need to have a portfolio of studies which address many aspects of the diagnosis and treatment of heart failure, and in part based on the changing knowledge base or clinical need. There is no guarantee that a proposed study will be conducted. The applications will be evaluated through NHLBI peer review. Standard review criteria judging the merits of the application will include an assessment of the proposed research as well as the demonstrated excellence of the investigators in the successful conduct of heart failure clinical research.
Q: What emphasis has the Network/NHLBI placed on a Regional Network for each of the RCCs?
A: Recruitment capacity is an important required element of each RCC. If the investigators at the RCC choose to partner with other institutions to facilitate enrollment of patients into studies, they are encouraged to recruit institutions that may be able to fill specific clinical/research gaps at an RCC. Examples are particular patient populations (minority or underrepresented populations) or a specific disease (diastolic heart failure, specific cardiomyopathies, etc.). The investigators should focus their efforts on those sites which will best be able to contribute.
Q: I am considering an application with 2 or 3 partner institutions that have unique relationship with my institution. I would like to fund them based in part on activity and commit some but not all the dollars for personnel at a set amount within the budget. This would be in addition to the per patient amount generated by the DCC (CC) for clinical studies. Is that a structure the NHBLI would support?
A: The RFA states that funds should be earmarked for specific FTEs for a study coordinator and other personnel. You should follow these guidelines when preparing a budget. Those sites that wish to partner with other institutions may choose to include support for the satellite or partner sites in the application. This would be in addition to the capitated site payments from the protocol fund administered by the CC. RCCs are reminded that any required initial start up costs for satellites must be included in the RCC budget.
Q: From a career standpoint, what are your thoughts about a new investigator as part of the Network? The concern is that if I applied for this Network and was successful I would lose my "new investigator" status for my next independent R01. What is the best move for my career from a long-term success standpoint?
A: The review criteria include a record of excellence in carrying out HF clinical trials, so past experience is evaluated. The incentives available for early stage investigators (ESIs) on investigator-initiated applications that are selected on the basis of percentiled paylines are not in place for program plans in response to NHLBI-initiated RFAs. Because the RFA is focused on identifying the best applications to meet the specific scientific and clinical requirements of the initiative, ESI status does not play a prominent role in the selection of applications for funding. Receiving funding as a PI, alone or as part of a multiple PI plan, in this Network would mean that subsequent applications would not be considered under ESI guidelines. Generally, staff does not have sufficient information to make recommendations to individuals regarding career choices. Decisions which may influence career paths might be discussed with one’s department Chair, advisor or mentors.
Q: After reading the eligibility information for requests for applications, it is unclear whether the word “Applicants” is in reference to an investigator/investigative team or the submitting institution as a whole.
A: There can be only one application per institution.
Q: I am working on a pilot study with a device manufacturer for disease management. A) Is this study consistent with the goals of the HF Network? B) If it is, what do I need to bring from them (perhaps letter of support with firm dollar commitment) to include in application?
A: This study could be consistent with the goals of the HF Network. It would strengthen your application to have a letter of support from the device manufacturer company.
Q: For Clinical Research Skills Development, is the intent to fund a fellow/junior faculty to pursue research (i.e. a targeted approach of one per year) or is it to implement a program that engages a larger number but with less intensity?
A: The intent of the skills development core is to provide an environment to train fellows and/or junior faculty in clinical heart failure trials methodology. Some examples of how the funds may be used include development or expansion of coursework in statistics and trial methodology, faculty mentoring, required class fees, travel and housing for rotations outside the home institution, travel to Steering Committee meetings or to present papers and abstracts.
Q: Is there a change in focus for the renewal application?
A: The RFA provides the objectives and specific requirements for RCCs and the CC. The reviewers will judge the applications based on the information provided in the RFAs and will score applications using the evaluation criteria as detailed in the RFA. An application that is not responsive to the RFA may be returned to the investigator.
Q: How and where in the new application do we address our achievements within the current Network? The larger question is how information about the performance of current sites is integrated into the expanded pool of applicants who have not been in the Network.
A: The RFA asks for experience of the research team, relevant to the program. Current Network participants are expected to demonstrate their performance by including bench mark data (e.g. network-generated score cards) and discussing their scientific leadership within the Network. New applicants are asked to include similar specific information regarding their successful participation in heart failure clinical trials.
Q: The original RFA required 2 protocols. It is implied but not overtly stated that the current application should only have 1.
A: The current RFA requests a single protocol. The applicants should also be aware of the new page limit on the PHS398 Research Plan Sections. See Table of Page Limits.
Q: Budgeting: The current RFA states that up to $230,000 will be awarded for infrastructure support exclusive of protocol implementation. That is how the original RFA was structured as well but the model changed, with a much smaller amount to be used for infrastructure and the balance to be used for the protocols using the 'banked hours’ plan. The question therefore is, will the renewed Network actually include that amount for infrastructure or since it says “up to” continue the 'banked hours' approach?
A: Budget decisions in the actual program may vary from those proposed in the RFA. The current RFA provides clear guidelines and caps for budget. It is recommended that one follows the instructions/ guidelines provided in the RFA. RCC applicants may find it useful to also read the CC instructions in RFA HL-12-002 and vice versa.
Q: I am a heart failure clinical researcher in Australia. I notice that the stipulation is that any overseas center must provide things that US centers cannot. One of the unique attractions of an RCC in Australia with connection to sites in New Zealand and Asia is early access to novel therapies and to different ethnicities. I am inquiring as to whether this type of collaboration would be of interest or something much more localized was required.
A: Foreign organizations are eligible to apply. Their applications have the added requirement of proposing research that would provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources. An overseas applicant should also explain how he/she envisions the integration of a remote site into a collaborative network in the United States and how the RCC could participate without extra cost or logistic barriers to the HF Network.
Questions for August- October 2010:
Q: Will regulatory monitoring by the Coordinating Center (CC) include assisting satellite sites with IRB submissions, contracts, certifications and the activation process?
A: Yes, the CC responsibilities reflect direct oversight of the satellites for regulatory and contractual matters. The RCC PI gives the encouragement, enthusiasm, scientific leadership and some resources (start up costs mandatory, FTEs optional) necessary for those sites to be successful, since they will reflect on the success of the PI.
Q: It is indicated in the RFA that the CC will now reimburse all satellite sites directly. Will satellite site reimbursement ultimately come from the RCC budget or will RCC no longer have any responsibility to reimburse satellites (other than start-up costs)?
A: The satellite sites will be reimbursed on a per-patient basis from the protocol funds by the CC. Any costs not directly linked to patient enrollment at the satellite sites are expected to be covered by the RCC budget- so this cost should be budgeted in the RCC application.
Q: Should the RCC budget include the cost of the proposed protocol?
A: RCC budgets are not expected to cost out the protocol. The RFA clarifies this in section IV.6. "Estimated protocol implementation costs should also not be included in the application budget although the proposed trial should be feasible for implementation in the described Network structure. Proposed protocols which will test or use patented pharmaceuticals or devices should include plans for in-kind industry support. Applications should clearly identify the potential source for any drugs or substances being considered for clinical protocols that are currently unavailable commercially. It should be noted that funds will not be provided for the purchase of expensive medical equipment, such as echocardiographic, cardiopulmonary exercise testing, magnetic resonance imaging or ultrafiltration systems"
Q: Can the .25 FTE for RCC PI be split between multiple PIs or must a single individual receive the entire 25% support?
A: The multi-PIs can add their efforts to reach the 25% and satisfy the requirements of the RFA. As a reminder, the applicants should take care for review purposes to make the case for the leadership plan, including demonstrating to reviewers that enough attention will be devoted to the oversight of the research. Relevant language from the review criteria follows: "If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the application provide evidence of a record of excellence in carrying out HF clinical trials?"
Q: Could the full-time FTE coordinator position be split between institutions?
A: Yes, the full time FTE could be split between institutions.
Q: I was wondering if there could be two PIs for the Clinical Research Skills Development Core application?
A: Yes, however it should be noted that the Skills Development Core is not a separate grant application, so part of the reason for the "yes" is that it does not carry the same administrative significance as being the PI on the overall grant. Remember that any other than traditional leadership plans should make the case for the benefit of that structure for review purposes.
Q: For the Clinical Research Skills Development Core could we include in the budget support for a group of mentors who would be advising and working with the trainees? This would be in addition to the leader of the Skills Development Core.
A: The Core was designed to develop new clinical investigators and as such, the support should be directed to educational activities. In this context some salary support for faculty would be appropriate.
Last updated: November 1, 2010