Caveats
We are interpreting the guidelines along
with you
 We may have some limited additional
insight due to participation during the
course of planning
 The NLAPS program is probably more
helpful to you than to SWOG

◦ No longer a “sponsored” relationship
◦ Involvement in multiple groups is likely
Network Lead Academic
Participating Sites (NLAPS)
RFA-CA-12-013
NCTN Network Lead Academic Participating
Sites will provide scientific leadership in
development and conduct of clinical trials in
association with 1 or more adult Network
Groups, as well as substantial accrual to
clinical trials conducted across the entire
NCTN.
NLAPS Overview
The eligibility to apply for these awards is restricted
to clinical academic centers.
Clinical academic centers are distinguished from
large medical centers whose primary mission is
patient care. In addition to patient care, clinical
academic centers have comprehensive medical
training programs and pre-clinical laboratories that
allow them to perform basic science research.
NLAPS Overview
Application to address;
 Clinical Trial Program


Illustrating well-defined plan for scientific input
across NCTN and institutional coordination within
the NCTN, including use of CIRB
Site Accrual Program
◦ Well-defined plan for accrual across the
NCTN, including rare cancers, for self and
for fully-managed affiliates.
Mandatory Use of CIRB
Clarity needed on many issues
 An exception exists:

◦ 35-48 days
NLAPS Overview
Convincingly demonstrate the potential to accrue at
least 55 to 70 patients per year to treatment and/or advanced
imaging interventions on adult cancer clinical trials.
 Accrual requirement reflects the lead academic site only

◦ a hospital and/or clinic program providing direct medical care to
patients that is considered one integral organizational entity under a
single financial management system and governance structure
◦ Hospitals, clinics, military or VA hospitals or treatment facilities, and
health care organizations that may provide services in collaboration
with the applicant institution in a network, but not under a single
financial management system and governance structure that
comprises the applicant institution may not be considered part of the
academic institution
NLAPS Overview
Network components of today = essential
components of tomorrow
 verify your network components meet the
criteria
NLAPS Overview
Affiliates of today are NOT the affiliates of
tomorrow
 For many, tomorrow’s affiliates are today’s
network components
 LAPS affiliates included in the application
must be fully-managed
 The NCI does not care if you continue to
have non-fully managed affiliates, but they
don’t belong in your funding request.
Membership
So how is SWOG going to manage this?
 “New” category of membership for non-fully
managed affiliates = “associates”

Current Category
Future Category
Network Component
Essential Component (under same financial
and governance structure)
Affiliate
Affiliate (fully managed affiliate of a NLAPS)
Affiliate (non fully managed)
Other (within SWOG, we are introducing
a subset of Other called “Associate” to
describe this)
How Can SWOG Support
Your Application

Long-standing members of SWOG will
need some accrual data from us
We need to confirm what Network Components
and Affiliates to include in reporting
We need to know what your reporting
period is
 We will provide it in the format from
the guidelines

◦ But it will only reflect SWOG and
SWOG- endorsed activities
How Can SWOG Support You

Letters of Support
◦ A template is helpful
◦ If you will be a new SWOG member, an
idea of your plans for how you will be
participating will be requested
What happens if you do not get
funded?
Still eligible for per-accrual payments
from the group
 Likely eligible as a High Performing
Site

◦ One year contract or grant direct from the
NCI at a higher level of reimbursement
Time-Lines
We should be able to run reports as
soon as we have all the required
information
 We will work on LOS as requests
arrive

◦

Please give us a week to complete a
request
We would like all activities to be
wrapped up by Dec. 17