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 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: ◦ 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 CategoryFuture Category Network ComponentEssential Component (under same financial and governance structure) AffiliateAffiliate (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