Canadian Cancer Clinical Trials Network Request for Application 2015 Network Affiliated Cancer Centre. Submission Guidelines

Transcription

1 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 April 1, 2015 Application Due Date May 1, 2015 Review Completion May 28, 2015 Notification of Award and Contract June 19, 2015 Award Period April 1, 2015 to March 31, 2018 Budget Contact Saher Lalani [email protected] E-Submission [email protected] Page 1 of 6

2 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 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. Page 2 of 6

3 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 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. Page 3 of 6

4 Local-Regional Clinical Trial Node NACC NACC NCC provides support ($/FTE/other) to increase regional recruitment. NACC gains: Support Trials Capacity Recruitment Per Case Funding 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 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. Page 4 of 6

5 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 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 Submission Information The completed Application Form and associated documents must be submitted electronically to [email protected] by May 1, 2015, 5 p.m. Page 5 of 6

6 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 Award Start Date Award start date is April 1, Award End Date Award end date is March 31, 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 protected]. Page 6 of 6