Update on the Cancer Centers
Program
Linda K. Weiss, PhD
Director
Cancer Center Administrators Forum
San Diego, CA
April 14, 2014
weissl@mail.nih.gov
http://cancercenters.cancer.gov
Overview
• PAR 13-386: Where have all the Guidelines gone?
• What should you consider as you prepare an
application?
• What changes are happening at site visits?
• Are there other policies/issues to be aware of?
• What is the status of the Cancer Centers Working
Group?
PAR 13-386: Where have all the Guidelines
gone?
• Electronic submission for P30 CCSG applications is
now required
• Plan ahead – there are more forms, a new arrangement
of components, and new page limits
• Rely on the FOA for application submission instructions,
not the 2012 Guidelines
– At this point, we do not plan to reissue CCSG Guidelines
– All information pertinent to the application is in the FOA
• “Peer Review Processes Relevant to the CCSG”, now a
separate document, is on our website
PAR 13-386: Where have all the Guidelines
gone? (2)
• Changes in Application Format and Organization
– Application is standardized to component ‘types’ defined
and approved by ASSIST:
•
•
•
•
Overall
Administration
Core
Project
PAR 13-386: Where have all the Guidelines
gone? (3)
• Changes in Application Format and Organization (2)
– General
• Some component ‘types’ have multiple components within them
• Most components request ‘Other Attachments’, e.g., tables,
diagrams and other forms
• Components may also have appendices
• Name of the component should be in the first line of component
text
PAR 13-386: Where have all the Guidelines
gone? (4)
• Changes in Application Format and Organization (3)
– Overall Component Type @ 30 page limit total to
include:
• Director’s Overview and Six Essential Characteristics
(“Facilities” has now become “Physical Space”)
• Official ‘Facilities’ form used to capture some information
• All Data Tables now in “Other Attachments”
– Administrative Core Component Type @ 12 page limit
total to include:
• Cancer Center Administration and Senior Leadership
PAR 13-386: Where have all the Guidelines
gone? (5)
• Changes in Application Format and Organization (4)
– Project Component Type @ 12 page limit each
• Research Programs
– Multiple “Other Attachments’” apply to this section
– Some additional minor changes in wording re reporting of
interventional trials, translation, value-added of shared resources
» (See Outline of FOA Changes)
PAR 13-386: Where have all the Guidelines
gone? (6)
• Changes in Application Format and Organization (5)
– Core Component Type @ 12 page limit each to include:
• Planning and Evaluation
• Developmental Funds
• Clinical Protocol and Data Management @ 12 page limit total
to include:
– Clinical Protocol and Data Management
– Data and Safety Monitoring
– Inclusion of Women, Minorities, and Children
• Protocol Review and Monitoring System
• Early Phase Clinical Research Support
• Shared Resources @ 12 page limit each
PAR 13-386: Where have all the Guidelines
gone? (7)
• Uploading the Application
– First sort will be in the component ‘type’ order
– Budget for ‘Overall’ will be summed total of components
– Within component ‘types’, individual components will be
uploaded in the order in which you put them into the
system
• For core components, preferred order is as in the sequence
presented above
• Consider uploading shared resources in ‘groupings’ – identify
group in text
• If you want groups of basic, clinical, and population science
programs to appear together in the application, they should be
uploaded together.
PAR 13-386: Where have all the Guidelines
gone? (8)
• OCC will work with applicants to clarify where and how
things are presented in the application
• Technical questions on the electronic submission
should be directed to ASSIST
• Program and review staff are briefing reviewers on the
format and limitations of the new electronic format
What should you consider as you prepare
an application?
• General Considerations
– Several components have been combined/shortened
• Some of these components have specified attachments, which
moves some data out of the narrative, but
• You should carefully consider what is most important to relay in
the application itself, vs. at the site visit, or not at all
What should you consider as you prepare
an application? (2)
• Overall (2)
– Budget instructions are now all in one specific section of
the FOA
– Only one set of biosketches is allowed
– “Other Attachments” are limited to those specified in the
FOA – they must be tables, graphs, lists, cannot include
narrative
– Appendices
•
•
•
•
Cannot be used to avoid component page limits.
Do not now include color photos
Should be discussed with the PD prior to inclusion
Are optional for review by peers
What should you consider as you prepare
an application? (3)
• Overall (2)
– LOI and RFI are now expected 60 days in advance of
the application
– Each section of the application asks: “Are human
subjects involved?”
• Centers should check yes in any component with research
directly supported by the CCSG, e.g., Dev. or EPCRS funds
• If you check yes in any individual component, you must check
yes in the same question in the ‘Overall’ component
– Applies to all clinical and comp centers but also to some basics
– If you check yes, ASSIST will require attachments on inclusion of
women, minorities, and children
– You can attach a pdf. indicating ‘not applicable’
– Inclusion data are reported as an ‘Other Attachment’ in CPDM
– Do not include planned enrollment tables
What should you consider as you prepare
an application? (4)
• The Catchment Area
– In Clinical Protocol and Data Management
• Define the catchment area
– should be population-based, straightforward and simple, have a
solid rationale
• Present a plan for assuring appropriate representation
• “Other Attachments” now include
– Summary information on the demographics of your defined
catchment area
– Tables in SF 424 format for accrual to interventional treatment,
interventional non-treatment, and non-interventional studies (not
planned enrollment)
What should you consider as you prepare
an application? (5)
• The Catchment Area (2)
– In Research Programs
• Make catchment area issues evident in the write-up, as relevant
• Focus on catchment area doesn’t have to be in
– all Programs – but is expected in clinical and pop sci
– all research projects within a Program
• Is not about outreach or accrual of minorities and women
• Not every sub-population has to be represented
• Many ways to substantiate
– In Senior Leadership
• Focus on how senior leaders monitor and facilitate research
– In Organizational Capabilities
• Focus on whether the center is organized to apply its expertise
and resources to research
What should you consider as you prepare
an application? (6)
• Shared Resources
– Document importance to the science in program writeups – what is the value added?
– Include a separate narrative and budget for each
– Group them any way you want
– Primary source of information for reviewers will be the
application
– At site visit, focus on updates and changes since the
submission
– Tours of the clinical trials office will continue; other tours
possible
What should you consider as you prepare
an application? (7)
• Education and training of biomedical researchers
and health care professionals
― Applicable to senior leadership – how the leaders work
together to monitor, coordinate, integrate and assess
the training efforts of the center
― Not a requirement of Research Programs
― Not just a list of training grants
What should you consider as you prepare
an application? (8)
• Comprehensiveness
― Some criteria have changed
• Depth and breadth of basic, clinical, and population
science
• Evidence of strong interdisciplinary science that bridges
these areas
• Service to the catchment area in terms of the research
supported
• Training and education that enables the scientific mission
― No longer a 2nd stage review focused on outreach
― Draft site visit report will have site visitors comments as
before
― Sub-committee A (Parent Committee) will vote on
comprehensiveness
What changes are happening at site visits?
• Time on site is a bit shorter
• Although centers have greater scheduling flexibility:
•
•
All programs are still being presented, though time allotted varies
In general, centers are presenting the same components as before
• Shared Resources are reviewed the night before the site
visit
― Most centers continue to have poster sessions but they are not
necessary
― Efficiency of shared resource groupings for review is still under
evaluation
― Reviewers still expect to see minutes, strategic plan
protocols, biosketches, etc.
Are there other policies/issues to be aware
of?
• Delayed Onset Human Subjects Research
– Delayed onset human subjects research policy applies
to “awards that were submitted with the intent to conduct
human subjects research during the period of support,
but for which definitive plans could not be described in
the application”
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD12-130.html)
– For P30 CCSGs, it may be relevant to projects funded
with Developmental or EPCRS funds
– If you anticipate that you will be funding human subjects
research projects, you should check ‘yes’ to human
subjects on the appropriate ASSIST form
Are there other policies/issues to be aware
of? (2)
• Delayed Onset Human Subjects Research (2)
– If you check ‘yes’ to human subjects, an attachment on
Protection of Human Subjects is required
– Indicate that these are delayed onset projects (or simply
N/A)- do not provide planned enrollment.
– No prior approval is required from OCC (except for
foreign clearance), but you must be able to document
appropriate IRB, PRMS, and DSM approvals
– T1/2 applications should include accrual for these
projects in the aggregate tables as before, but
– T5 progress reports should describe project status and
provide accrual data by project using SF 424 forms
Are there other policies/issues to be aware
of? (3)
• Electronic Submission of T5 Progress Reports
– Electronic submission of T5 Progress Reports (RPPR)
for P30s are tentatively scheduled for implementation on
October 17th
– Reports submitted prior to that time may be submitted in
paper format or electronically – it’s your option
– OCC is evaluating the progress report requirements and
how they fit with the RPPR format and will apprise you of
any changes prior to the scheduled implementation date
Are there other policies/issues to be aware
of? (4)
• PMCIDs should be obtained for all publications
receiving direct cost support from CCSG
• Pilot projects supported by CCSG Developmental and Early
Phase Clinical Research Support funds
• Shared resources providing subsidies/discounts or other types
of direct cost support
• These publications should be listed in Section E of the
paper progress report, Section C.1 of the RPPR
• All publications in Section E must be ‘compliant’ for the
renewal NGA to be issued
• Significant scientific publications that are not supported
directly by the CCSG may be listed in the Research
Programs section
Are there other policies/issues to be aware
of? (5)
• Data Table 4 and the Clinical Trials Reporting Program
(CTRP)
– CTRP is testing the capabilities of their system to
generate DT 4 for interventional trials
– They will be contacting centers to discuss how the
CTRP and CCSG versions compare
– Center administrators and OCC program directors will
be asked to participate
– As data on non-interventional studies are not routinely
collected by CTRP, they will not be a part of this pilot
– Our program and IT staff are meeting with CTRP staff on
a monthly basis to assess progress, issues, etc.
Are there other policies/issues to be aware
of? (6)
• Clinical Trials involving rare diseases and molecular
subtypes
– Accrual to these trials is typically low at any one site –
participation of many institutions is required
– OCC communicated with center directors and
administrators in 2012 and 2013 about the key role your
centers play in these trials
– We requested that the Center PRMS make exceptions
for these trials in terms of accrual and explicitly
recognized the importance of these in the FOA
– Please remind your PRMS committees of the importance
of your continued participation in these trials
What is the status of the Cancer Centers
Working Group (WG)?
• Phase I – A possible new approach to funding
– The WG Chair, Dr. Wm. Hait, made a report to the
NCAB and the center directors on a possible new
approach to centers funding (slides are available)
– OCC is collaborating with the NCI Office of Budget and
Finance to refine potential models and assess
whether/how the new approach might best be
implemented
– The NCAB has not yet ‘accepted’ a WG final report
– No implementation date is established – this is still a
work in progress
What is the status of the Cancer Centers
Working Group (WG)?
• Phase II – Streamlining applications
– The WG will continue its work, now focusing on potential
streamlining of applications
– Most of the current group of directors has agreed to stay
on, but Dr. Beckerle will chair this phase
– Several administrators have been added to the WG
•
•
•
•
Brian Springer, Co-chair
Bob Gerlach
Lauren Hackett
Anita Harrison
For additional information:
FOA:
http://grants.nih.gov/grants/guide/pa-files/PAR-13-386.html
Notice of Correction:
http://grants.nih.gov/grants/guide/notice-files/NOT-CA-14008.html
Outline of FOA Changes:
http://cancercenters.cancer.gov/grants_funding/Outlineof20
14FOAChanges508.pdf
Peer Review Processes Relevant to the CCSG:
http://cancercenters.cancer.gov/grants_funding/PeerRevie
wProcessesRelevanttotheCCSG508.pdf
FAQs:
http://cancercenters.cancer.gov/faq.html
Thank you.
Questions?