Download CSCPDPC FAQ Consortium for the Study of Chronic Pancreatitis

CSCPDPC FAQ
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Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer
Clinical Centers (CSCPDPC -CCs) (U01)
(RFA-DK-14-027)
National Institute of Diabetes and Digestive and Kidney Diseases
National Cancer Institute
Application Receipt Date(s): April 02, 2015
Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer
Coordination and Data Management Center (CSCPDPC- CDMC) (U01)
(RFA-DK-14-028)
National Institute of Diabetes and Digestive and Kidney Diseases
National Cancer Institute
Application Receipt Date(s): April 02, 2015
1.-If I apply, do I have to include in my application a DCC and all the consortiums? or does a DCC apply
separately and all the individual sites apply separately and then a consortium is build of the 6 or so
centers selected?
Applications are submitted separately to each of the RFAs. The same institution can apply (under
different PIs) to both RFAs.
2.-In this 30-page proposal do I describe the clinical trials I propose at only our site or plans to conduct
the studies as part of a consortium /network.
Describe your capabilities to contribute to the objectives of the CSCPDPC: expertise in the topic and
capability to enroll and retain patients. We are also interested in proposals to engage in studies on the
pathophysiology of CP. These proposals (which can involve a given center, based on unique expertise or
the whole consortium) will be considered by the Steering Committee of the CSCPDPC.
3.-Do I apply separately? or say if I want to collaborate with another pancreas center; do we submit
separate or one application?
You can apply as a CC (by itself) or can join another group (i.e. Dr. X). In this last case, Dr.X is the
applicant.
4.-Do I have to propose other members/institutions with whom I would like to collaborate?
No. You can submit as a single center or create a local or regional network of investigators. In either case
the budget for the clinical site (single or network) is limited to up to $270,000 Direct Cost.
5.-Can I propose pre-clinical (basic) or animal studies as part of my proposal?
No. Basic or animal studies will not to be considered by the Consortium. These studies can be
submitted using other FOAs
6.-What capabilities/resources do I have to describe to qualify for consideration?
For a Clinical Center, the applicant must demonstrate experience and expertise to conduct clinical
studies in chronic pancreatitis and associated pancreatic cancer. The applicant must discuss the number
of patients with chronic pancreatitis seen at the center during the previous 12 month period that might
be eligible to enroll and describe potential study participants by sex, age categories, and ethnic/racial
distribution, as well as recruitment source.
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For a Coordinating and Data Management Center, the applicant must demonstrate experience in the
area of coordination of multi-center clinical trials and epidemiological studies in all phases: protocol and
manual of operations development, staff training in study procedures, research instrument
development, data collection and management, quality assurance, data analysis, distributed data entry,
electronic communications, administrative management and coordination.
7.-For a CDMC application, do I have to have expertise in conducting clinical trials in chronic
pancreatitis?
No. Specific experience in coordinating or monitoring studies of pancreatic disease is not required, but
the applicant may wish to include a pancreatologist in the application as a key collaborator and advisor.
8.-What constitutes “patient care costs” that are exempt from the budget?
Two types; 1) cost for compensation and incentives to patients approved by local IRB (i.e. parking, local
travel, etc), 2) cost for research or diagnostic studies ( not considered standard of care or paid by health
insurance) APPROVED by the CSCPDPC Steering Committee. Patient care costs are not included in the
budget requested by the clinical center applicants. The cost to enroll patients will be approved and
allocated to each site based in their enrollment activity.
9.-On what basis/bases will the applications be evaluated?
The application will be evaluated using the review criteria described in the corresponding RFA.
10.-Can I propose a study in which an assay/test/model I have developed can be applied to samples
collected from other sites?
Yes. while each applicant for a Clinical Center will propose protocols in their individual applications, the
final studies to be carried out by the consortium will be determined post-award through meetings of the
Consortium Steering Committee. Applicants are expected to propose studies that will further the
objectives indicated above.
11.-Is the budget for a research coordinator at my site to be included in my center budget or the DCC
budget?
The budget for a Clinical Center application is up to $270,000 DIRECT Cost. The budget which has to be
fully justified by the scope of the work proposed supports clinical investigator(s) and coordinator(s)
efforts to recruit and follow patients and to participate in all required activities of the CSCPDPC.
12.-Can I propose a collaborative clinical project which would require a central lab to perform assays
without including the cost of the TBN central lab in my proposal?
While each applicant for a Clinical Center will propose protocols in their individual applications, the final
studies to be carried out by the consortium will be determined post-award through meetings of the
Consortium Steering Committee. The costs of proposed clinical, diagnostics studies or interventions are
not to be described or be considered in the budget allowed to Clinical Centers.
13.-The RFA mentions a “central IRB”: Is there a single IRB to which project proposals will be submitted?
There’s not a central IRB at this point, but it could be considered in the future.
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14.-My center has a high volume of PDAC cases but no single intake clinic. Can I still apply as a center?
What skills or experience or resources do I need to provide in the application?
Yes. Your center can bring local clinical sites (other institution or private practices). Remember the
budget cap which will support the staff involved at all sites, remains $270.000 Direct cost. Alternatively
some of the “offsite” clinics could be brought it under a per patient capitated reimbursement to be
determined once the Consortium is formed.
For a Clinical Center, the applicant must demonstrate experience and expertise to conduct clinical
studies in chronic pancreatitis or pancreatic cancer. The applicant must discuss the number of patients
with chronic pancreatitis seen at the center during the previous 12 month period that might be eligible
to enroll and describe potential study participants by sex, age categories, and ethnic/racial distribution,
as well as recruitment source.
15.-My center has a high volume of PDAC cases but most are referred from distant locations and don’t
usually return here for follow-up care. Can I still propose a study as part of the consortium?
The success of a clinical center is mostly predicated on its ability to enroll and retain patients during the
course of the study which is several years. If your site can’t fulfill that requirement it won’t be very
competitive.
16.-I see a large number of patients with pancreatogenic diabetes in my center. Can I propose a clinical
study/trial of a new treatment for this disorder as part of this initiative? If so, how do I indicate that this
might be better conducted as a multi-site study so as to achieve sufficient numbers?
Each applicant for a Clinical Center can propose protocols in their individual applications, the final
studies to be carried out by the consortium will be determined post-award through meetings of the
Consortium Steering Committee. Any clinical study proposal has to be design and adopted (if approved
by the CSCPDPC Steering Committee) by the whole consortium.
17.-Is it more important to propose a project/idea or to demonstrate the resources and capabilities of
my center in my application?
The mission of the CSCPDPC can only be accomplished by having patients (resources and capabilities)
and motivated, creative clinical investigators proposing ideas. Therefore while both are essential
requirements for the success of the consortium, demonstration of resources and capabilities is primary
(can’t do great clinical studies, without patients).
18.-Do we pre-select the sites, or will then NIDDK mix and match after the applications are evaluated?
Applicants for a Clinical Center can come as single site or select additional available local or regional
sites to come as a network (in any event the budget for the CC is limited to $270K direct cost). The
NIDDK/NCI staff will after review of all the meritorious applications select the participating clinical
centers and the CDMC.
19.-Will there only be one program approved? (e.g. should INSPPIRE be linked with NAPS2 or will these
sites be competing?)
Each interested/qualified PI will submit an application for a Clinical Center (CC). The CC application can
be adult, pediatric or both; can be single site or a site taking the lead to bring a network structure.
The budget for a CC site (single or composite) is up to $270K direct cost, with appropriate justification.
This budget supports the PI(s)/coordinator(s) effort, institution’s resources, travel, etc. The cost to enroll
patients will be approved and allocated to each site based in their enrollment activity.
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20.-Can there be Co-PIs on an application?
Yes, Co-PIs (collaborators) and Multiple Program Director/Principal Investigator are allowed in clinical
centers or CDMC applications.
21.-What if I already have a network of centers that I collaborate with; can we submit as a single center
or does each center have to submit a separate application?
You can apply as a single center or as a network which is already established. In any event, the budget
cap for your application would be $270,000 per year in Direct Costs. Alternatively some of the “offsite”
clinics could be brought it under a per patient capitated reimbursement to be determined once the
Consortium is formed.
22.-How should we decide who should be the PI of our center’s application?
This is up to the applicant institution. Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s)
PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals
from underrepresented racial and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.
23.-How will you decide who should be the PI of the Consortium?
A Chairperson of the Steering Committee, other than the NIDDK or NCI Project Scientist, will be selected
by the NIDDK, in consultation with the NCI. The Chairperson provides leadership to the Committee by
conducting the Steering Committee meetings, representing the study group to the External Oversight
Committee established by the NIDDK and by interacting closely with the awardees during protocol
development and implementation.