2015 NACC RFA Guidelines - Canadian Cancer Clinical Trials

Canadian Cancer Clinical Trials Network
Request for Application 2015
Network Affiliated Cancer Centre
Submission Guidelines
Lead Organization
Announcement
Type
Purpose
Eligibility
Available Funding
Canadian Cancer Clinical Trials Network (3CTN)
This is a Request for Application (RFA) for Network Affiliated Cancer Centres
(NACC) that have been identified on successful Network Cancer Centers (NCC)
applications as affiliated centres and/or centres with the potential to be a
NACC.
This RFA invites applications from identified and potential NACCs to be part of
3CTN to support and improve the efficient delivery of cancer clinical trials
within their regional node. The regional node is defined as the geographic
location, its population served by the NCC and collaborating NACCs.
The role of NACC is to: a) ensure centre participation and performance; b)
increase trial participation and recruitment from its centre; c) implement 3CTN
initiatives and best practices.
NACC sites identified in the NCC RFA and/or centres with the potential to be a
NACC site. The NACC must have the capacity to recruit directly to a portion of
the portfolio trials and/or refer patients to a broader range of trials at larger
centres.
Funding/award is for Per Case Funding (PCF) defined as patient recruitment
above a predetermined baseline.
Key Dates and Contact Information
Posted Date
Application Due Date
Review Completion
Notification of Award and Contract
Award Period
Budget Contact
April 1, 2015
May 1, 2015
May 28, 2015
June 19, 2015
April 1, 2015 to March 31, 2018
Saher Lalani
[email protected]
E-Submission
[email protected]
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1. Funding Opportunity Description
1.1.
Purpose
This RFA invites applications from identified as well as potential centres to be designated as a NACC and to
apply for PCF within 3CTN. NACCs will be part of the Network to support and improve the efficient delivery
of academic sponsored cancer clinical trials within their institution and their local-regional clinical trials
node. The successful applicants will work with their respective NCC to implement activities and address
impediments to patient access and the execution of academic cancer clinical trials.
The objectives of the NACC are to:
 Directly participate in Network portfolio of trials;
 Refer patients to NCCs for participation in trials.
To achieve the Network objectives, the NACCs are encouraged to work with their NCC on local-regional
objectives. The achievement of these objectives will demonstrate local-regional success within 3CTN and
contribute to the achievement of the overall 3CTN objectives.
The responsibilities of the NACC include;
 Represent the centre within 3CTN;
 Collaborate with the NCC to meet Network trial and accrual targets;
 Manage the centre to meet performance metrics, reporting of metrics and management of funding;
 Assist with the initiation of portfolio trials and monitor trial activity within the cancer centre;
 Implement Network initiatives, tools, best practices, standard operating procedures;
 Communicate 3CTN activities within the centre.
Each NACC will be led by a Principal Investigator (PI) who will champion 3CTN within the institution,
oversee and ensure effective implementation and utilization of resources, and report metrics, deliverables
and finances as well as other deliverables.
1.2.
Background
Canada has an outstanding history of cancer clinical trials conduct, with world-class clinical collaborative
groups that conduct early to late-phase trials, as well as a community of internationally recognized cancer
researchers. Conducting clinical trials in the academic environment has become increasingly challenging,
particularly due to an increase in the complexity of regulatory processes and of trial objectives and study
designs, associated with a reduction in institutional resources. This has resulted in academic clinical trials
centres and organizations struggling to find resources to fund increasingly complex trials. Consequently,
the principal source of funding for cancer clinical trial activities has started to shift to the pharmaceutical
industry. The pharmaceutical industry focus is on the approval of new drugs, leaving a large number of
relevant “practice changing” studies to be conducted by the academic community. Therefore, there are
considerable advantages to strengthening and supporting the academic cancer clinic trial community and
to creating better integration between research laboratories and health care communities to translate
many scientific discoveries to the clinic.
In 2011, the Canadian Cancer Research Alliance (CCRA) published a report that identified this challenging
situation in Canada and recommended that the issue be addressed urgently. As a result, in 2013 the
Canadian Partnership Against Cancer (CPAC) launched a competition for proposals to establish 3CTN to
strengthen academic sponsored cancer clinical trials capacity in Canada. In June 2013, led by Dr. Janet
Dancey, the 3CTN Coordinating Centre was established at the Ontario Institute for Cancer Research
(OICR) in collaboration with the NCIC Clinical Trials Group and the Network of Networks. In May 2014, an
international panel of experts reviewed the 3CTN business plan and recommended that it be implemented
and funded. The purpose of this RFA is to identify individuals and sites interested in becoming 3CTN
NACCs.
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1.3.
Overview of 3CTN
Vision: Canadians with cancer and those at risk will have the best available cancer treatments through
access to and efficient execution of academic cancer clinical trials.
Mission: To support and improve the efficient delivery of cancer clinical trial results that will define medical
practice by addressing impediments to patient access and execution of academic cancer clinical trials
through funding, resources and advocacy to improve the clinical trial environment.
Overall 3CTN goals and objectives are to:
 Improve patient access to academic clinical trials;
 Improve site performance of academic trials;
 Improve the trial environment for the conduct of academic clinical trials through collaboration and
facilitation of important national trial initiatives;
 Demonstrate impact of the Network and academic trials on the Canadian Health System.
1.4.
Organization of 3CTN within a region/province
Within a larger province (BC, AB, ON, QC) or large geographical area (i.e. SK-MN, Atlantic Canada) there
will be one Network Regional Coordinating Centre (NRCC) and multiple NCCs linked to affiliated centres to
form local-regional nodes that will coordinate Network trial activities.
A local-regional node includes the NCC and its affiliated NACCs (Figure 1). The NRCC will facilitate
interactions between multiple local-regional nodes, and support and represent the region on the 3CTN
Steering Committee. The local-regional node will work together to increase recruitment and access to
academic trials and meet regional milestones and deliverables.
The Application must include:
 Overview of the NACC clinical trials program and leadership;
 Status of academic clinical trials (ACT) and plans to increase recruitment;
 Goals and objectives of the NACC;
 How the NACC is linked to the NCC;
 How this linkage is to assist with increasing in recruitment to ACT.
Institutions will retain full responsibility for deciding which trials they participate in within the Portfolio.
NACCs will receive PCF and 3CTN will establish contractual agreements with the NACCs to disburse funds.
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Local-Regional Clinical Trial Node
NACC
NCC provides support
($/FTE/other) to
increase regional
recruitment.
NACC gains:
↑Support
↑Trials Capacity
↑Recruitment
↑Per Case Funding
NACC
NCC
NACC
NACC increases trial
activity through patient
recruitment, referral
and trial participation.
NCC gains:
↑Core Funding
↑Referrals
↑Recruitment
↑Per Case Funding
Figure 1: Local-Regional Clinical Trial Node
2. Eligibility Information
2.1.
Eligible Institutions
Eligible applicant institutions are centres that can recruit patients to Network portfolio trials, do not meet
the criteria to become a NCC, and can benefit from linking to a NCC.
2.2.
Eligible Individuals
The PI must be an individual with the capability to take on the required Network roles and responsibilities.
The PI need not be a clinician but must be an individual who is capable of leading/championing the
Network at the site. The Clinical Research Associate must be an individual knowledgeable in clinical trial
operations and management.
3. Funding Information
3.1.
Available Funding
NACCs qualify for PCF for patient recruitment above baseline to the 3CTN portfolio of trials. PCF is
ineligible for overhead or indirect costs.
4. Application and Submission Information
4.1.
Application Package
Applications should be completed in Times New Roman, font size 12 and must include:
 Completed 2015 NACC Application Form (Word document);
 Completed Milestones and Deliverables, in Excel format on form provided;
 Budget and Justification in Excel format (predetermined, review for verification of baseline);
 Resume of PIs and CRA;
 PDF document including, in order:
o Completed 2015 NACC Application Form;
o RFA 2015 Baseline Information Form;
o Completed Milestones and Deliverables;
o Budget and Justification;
o Resume of PIs and CRA.
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3CTN 2015 Application Form
Section 1: Applicant Information
 Complete the information for Institution Administrative Authority, Financial Officer, NACC PI, NCC PI,
NACC Co-PI or Lead CRA.
Section 2: Overview of NACC (Applicants must respond to all four questions.)
(Response must be limited to two pages)
1. Describe the clinical trials program and leadership at the NACC.
2. Outline the number of academic clinical trials (ACT) open and recruiting to ACT per year. Describe the
plan to increase recruitment to ACT at the NACC.
3. Identify NACC goals, objectives and milestones and deliverables (M&D). The NACC goals, objectives
and M&D must align with the affiliated NCC.
4. Describe how NACC linkages with the NCC will assist with increasing recruitment to ACT.
Section 3: Budget
The budget is predetermined for salary support (as allocated by the NCC) and PCF aggregate
amount is derived using the NACC baseline.
 Confirm NACC baseline patient recruitment number in the budget document;
 Review the overall budget and edit the baseline patient recruitment number if required.
Section 4: Milestones and Deliverables (M&D)
Complete M&D using the 2015 NACC Milestones and Deliverables Template.
 The milestones and deliverables must align with the affiliated NCC M&Ds and include but are not
limited to:
o Increase patient recruitment by the percentage above the established baseline;
o Increase number of academic trials based on the portfolio;
o Complete quarterly reports (patient recruitment and financial report);
o Annual reports (performance and financial report).
Resume of the NACC PI, NACC Co-PI and CRA may be in the most convenient format and must contain:
 Relevant clinical trials management and operational experience;
 Work experience, appointments.
Baseline Information Form: NCCs have submitted recruitment data on trials that meet the portfolio
eligibility criteria for 2011, 2012 and 2013. The baseline will be the patient recruitment for each site, and
in aggregate the totals will form the baseline for Canada. Please review and confirm the NACC
baseline patient recruitment numbers in the attached NACC Prefilled Budget.
4.2.
Submission Information
The completed Application Form and associated documents must be submitted electronically to
[email protected] by May 1, 2015, 5 p.m.
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5. Application Evaluation Process
5.1.
Review
NACC applications submitted for the 2015 NACC RFA will be reviewed by 3CTN staff for congruence to
their corresponding NCC Application, quality of application and the feasibility to assist NCCs in their goals
and objectives in their region.
6. Award Administration Information
6.1.
Notification of Award
Successful applicants will be informed in writing of the outcome of the review within 14 working days of
approval.
6.2.
Award Start Date
Award start date is April 1, 2015.
6.3.
Award End Date
Award end date is March 31, 2018.
6.4.
Contractual Agreement
Successful applicants will be required to enter into a contractual agreement with OICR as the legal entity
for 3CTN, formalizing the funding commitments, cash flow requirements, milestones and deliverables,
performance measures, reporting requirements, specific conditions and other general terms governing the
initiative. In fulfilling this contract, 3CTN will be responsible for reviewing the milestones and deliverables
and budget and determining whether or not the institutions have met their commitment to the contract.
7. Contact Information
For questions regarding application instructions and process, email [email protected].
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