OpportunityTitle: DoD Kidney Cancer, Clinical Consortium Award
Description: The KCRP Clinical Consortium Award is intended to support a major goal, a consortium of exceptional institutions and leading investigators to advance high-impact, novel therapeutic strategies and interventions to improve patient outcomes and significantly decrease the impact of the disease (the &#8220;Consortium&#8221;). The objectives of the Consortium shall be to design, develop, and conduct Phase I or Phase II-linked Phase I (Phase I/II) clinical trials of promising therapeutic agents for the prevention, detection/diagnosis, management, or treatment of kidney cancer. The KCRP Clinical Consortium Award provides the support to develop and enhance collaborations and resources necessary for a network of organizations to rapidly execute investigator-initiated kidney cancer clinical trials. Support from this award is directed toward Consortium infrastructure needs rather than direct support of the research itself. Applicants are expected to demonstrate a broad understanding of kidney cancer research, including knowledge of the current state of clinical studies and clinical priorities related to kidney cancer and are encouraged to familiarize themselves with the KCRP&#8217;s Strategic Plan, and to consider this material when preparing their application. The anticipated direct costs budgeted for the entire period of performance for an FY19 KCRP Clinical Consortium Award will not exceed $3M for the Coordinating Center and will not exceed $600,000 for each Clinical Trial Site. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. To facilitate global investigations, U.S. and international institutions are encouraged to apply. Submissions from institutions with enhanced access to patients in the Military Health System and/or from disproportionately affected populations (including, but not limited to, socioeconomic status, access to health care, age, geography, race, and ethnicity) are especially encouraged. The FY19 KCRP Clinical Consortium Award mechanism is designed to fund a single Coordinating Center and a minimum of three Clinical Trial Sites (the Coordinating Center will count as one of the three Clinical Trial Sites), each through separate awards. Principal Investigators (PIs) will be required to indicate in the pre-application whether the institution is applying as either the Coordinating Center with a Clinical Trial Site or as a Clinical Trial Site only. The Coordinating Center and Clinical Trial Sites will be jointly responsible for proposing, selecting, and conducting Phase II and Phase I/II clinical trials focused on kidney cancer therapeutic interventions. The Coordinating Center and Clinical Trial Sites funded by the FY19 KCRP Clinical Consortium Award may work with additional Clinical Trial Sites that may be funded by the KCRP in future fiscal years. Additional details regarding the structure of the consortium are described below. The Coordinating Center, in addition to functioning as a Clinical Trial Site, will serve as the Consortium information and planning nexus providing administrative, operational, and data management support services to participating Clinical Trial Sites to implement Consortium clinical trials in a timely manner. Responsibilities of the Coordinating Center will include coordinating the clinical trial selection process, protocol coordination, regulatory coordination, study management and monitoring, data collection, management and statistics, and intellectual/material property coordination. The Coordinating Center will also be responsible for preparing two clinical trials, with funding already secured, to be initiated by the Consortium within the first 6 months of the performance period. In addition, the Coordinating Center will coordinate and promote best practices for human subject recruitment and will aid Clinical Trial Sites in directing potential subjects to the most appropriate trials. All Sites (Clinical Trial Sites and the Coordinating Center) will be required to participate in at least one of these two initial clinical trials. Collectively, the Coordinating Center PI, the PI from each Clinical Trial Site, and consumer advocates will constitute the Clinical Consortium Steering Committee. The consumer advocates must be kidney cancer patients, or caretakers for someone with kidney cancer, and possess a high-level familiarity with current issues in kidney cancer research. The consumer advocates&#8217; role in the committee should be independent of their employment with a participating institution. During the Consortium&#8217;s period of performance, the Coordinating Center PI will chair the Steering Committee. The Clinical Consortium Steering Committee will collaboratively develop and maintain a procedure for the selection of clinical trials to be implemented within the Consortium. The KCRP Grants Officer Representative (GOR) must be invited to meetings of the Clinical Consortium Steering Committee as well as any other formal meetings of the Consortium. All Sites will be responsible for working collaboratively to identify new clinical trials for implementation. Any site may serve as an entry point for clinical trials that originate from outside the consortium. The Coordinating Center will be responsible for facilitating this entire process. The consortium should leverage other Department of Defense (DoD) investment opportunities whenever possible (e.g., to support correlative studies, clinical trial PIs are strongly encouraged to apply for translational awards offered by the DoD). A Congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, CDMRP encourages applicants to review the recommendations (https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY19 KCRP priorities. The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public. Key requirements of the Clinical Consortium Award include: 1. Responsibilities of the Consortium Participants: Procedures for the Consortium, while proposed by the Coordinating Center, will be fully developed and agreed upon by all participants working collaboratively. At the discretion of the Government, a pre-award planning meeting may be required. a. Coordinating Center. Responsibilities specific to the Coordinating Center include: &#9675; Adherence to the responsibilities delineated below for a Clinical Trial Site. &#9675; Coordination and facilitation of at least two open clinical trials at all times after the first 6 months of the performance period. &#9675; Development and maintenance of the Consortium organizational structure. &#9675; Provision of at least two initial interventional clinical trial protocols that will be open for recruitment by the Consortium within the first 6 months of the performance period. &#9675; Management of Consortium-developed procedures for review, selection, and implementation of clinical trials proposed by or through Consortium members. &#9675; Establishment and management of procedures to ensure compliance with the local institutional review boards (IRBs) of all Sites for the conduct of clinical trials and the protection of human subjects. &#9675; Establishment and management of procedures for ensuring compliance with U.S. Food and Drug Administration (FDA) requirements for investigational agents, devices, and procedures. &#9675; Establishment and management of a communications plan and an ongoing communications system between the Coordinating Center and Clinical Trial Sites. &#9675; Management of Consortium-developed quality assurance and quality control mechanisms for study monitoring, including: &#8722; Real-time and remote monitoring program &#8722; Management plan for the handling, distribution, analysis, and banking of specimens and/or imaging products generated from Consortium studies necessary for the conduct and analyses of clinical trials during the performance period of the award &#8722; Registration, tracking, and reporting of participant accrual &#8722; Timely medical review and assessment of participant data &#8722; Rapid reporting and communication of adverse events &#8722; Interim evaluation and consideration of measures of outcome &#9675; Management of Consortium-developed comprehensive data collection and data management systems that address the needs of all sites in terms of access to data, data security, and data integrity measures. &#9675; Development of statistical plans for all Consortium clinical trials. &#9675; Management of Consortium-developed intellectual and material property issues among institutions participating in the Consortium. &#9675; Management of Consortium-developed procedures for the timely publication of major findings and other public dissemination of data. &#9675; Development and execution of plans for ongoing review by the Consortium&#8217;s External Advisory Board (EAB), to include participation by Government representatives. EAB reviews should be conducted no less than twice yearly. b. Clinical Trial Sites. The responsibilities of each site include: &#9675; If required by the Government, participation in a pre-award planning meeting with all Consortium members to discuss operational features of the Consortium, the requirements for progress and evaluation, and the award negotiations process. &#9675; Full participation in the Consortium, including but not limited to, clinical trial introduction and selection, patient accrual for Consortium studies (to consider disproportionately affected populations [see https://seer.cancer.gov]), data collection and timely submissions, meeting attendance, and adherence to the Consortium&#8217;s operating procedures. &#9675; Presentation of at least two clinical trials for the Consortium&#8217;s consideration per year. &#9675; Meeting minimum accrual requirements of 25 patients per year for each open and recruiting clinical trial, either independently or in partnership with other non-Consortium institutions. At least 20% of these patients must be contributions to trials from other Consortium Sites, and at least 5% of all accrued patients at each site must be from disproportionately affected populations. &#9675; Provision for a Clinical Trial Coordinator, who will interact with the Clinical Trial Coordinators of other Clinical Trial Sites and the Supervising Clinical Trial Coordinator of the Coordinating Center to expedite and guide clinical protocols through the regulatory approval processes, to coordinate patient accrual and study activities across Sites, and foster communication with other Consortium Clinical Trial Coordinators. &#9675; Implementation of the Consortium&#8217;s core data collection methodology and strategies. &#9675; Compliance with Consortium-developed quality assurance and quality control procedures, as appropriate, including: &#8722; Participation in a monitoring program to be managed by the Coordinating Center. &#8722; Implementation of the Consortium-developed management plan for acquisition, delivery, and storage of biological samples and study data. &#8722; Submission of appropriate data and materials to allow for verification and review of protocol-related procedures, for example, pathology, imaging techniques, surgical methods, and therapeutic use. &#9675; Implementation of procedures established by the Coordinating Center for ensuring compliance with FDA requirements for investigational agents, as appropriate. &#9675; Implementation of procedures established by the Coordinating Center to meet the local IRB requirements for the conduct of clinical trials and the protection of human subjects. &#9675; Participation in Consortium-developed procedures for the timely publication of major findings. &#9675; Participation in Consortium-developed procedures for resolving intellectual and material property issues among institutions participating in the Consortium. &#9675; Participation in ongoing review by the Consortium&#8217;s EAB. &#9675; Submission of annual written progress reports, a final written comprehensive report, and any other reports required by the Government to be outlined in the assistance agreement. &#9675; Additional responsibilities based on recommendations and guidance from the consortium EAB and U.S. Army Medical Research and Materiel Command (USAMRMC) staff. 2. Performance Metrics Exercise of the options for continued performance of each participant site after the first year will be contingent upon meeting performance metrics as specified in the award agreements. a. Metrics for Coordinating Center Performance &#9675; Presentation of at least two clinical trials for the Consortium&#8217;s consideration per year. &#9675; Maintain a portfolio of at least two open trials per year after the first 6 months of the period of performance. &#9675; Meeting minimum accrual requirements of 25 patients per year from each open and recruiting clinical trial, either independently or in partnership with other non-Consortium institutions. At least 20% of these patients must be contributions to trials from other Consortium sites, and at least 5% of all accrued patients at each site must be from disproportionately affected populations. b. Metrics for Clinical Trial Site Performance &#9675; Accrual of at least 25 patients per year to each open and recruiting clinical trial, either independently or in partnership with other non-Consortium institutions. &#9675; Participation in a minimum of two trials per year initiated by any of the Consortium sites. &#9675; Presentation of at least two trials per year to the Consortium for consideration. &#9675; Timely submission of quality data as outlined by the Coordinating Center. 3. Oversight of the Clinical Consortium Award An EAB composed of kidney cancer researchers and consumer advocates who are not involved with the Consortium and KCRP Programmatic Panel members will provide administrative and scientific guidance to the GOR; the EAB will be assembled by the Clinical Consortium Steering Committee. The EAB Chair and a representative from USAMRMC will be invited to regular meetings of the Clinical Consortium Steering Committee and must be provided agendas and minutes for these meetings. The Coordinating Center PI and Clinical Trial Site PIs must present written and oral briefings to the EAB at semi-annual 1-day meetings. Based on these reports and presentations, the GOR, with input from the EAB and USAMRMC staff, will evaluate progress, provide feedback, and recommend to the USAMRAA Grants Officer actions to be taken as needed to facilitate the success of the Clinical Consortium Award. The Coordinating Center PI may also be required to submit quarterly progress reports. The Coordinating Center and all Clinical Trial Sites will be required to submit a final comprehensive written report of the Consortium&#8217;s accomplishments to the USAMRMC. The CDMRP expects to allot approximately $7.68M over a 3-year period to fund approximately one Clinical Consortium &#8211; Coordinating Center and three Clinical Consortium &#8211; Clinical Trial Site Award applications. A total of $2.56M will be allocated from the FY19 KCRP budget to fund the first year of performance. Options will be included for continued performance in subsequent years, with $2.56M expected from each of the FY20 and FY21 KCRP budgets. The initial performance period of the award and each option period will be for 12 months. Funding of applications received is contingent upon the availability of Federal funds for this program as well as the number of applications received, the quality and merit of the applications as evaluated by scientific and programmatic review, and the requirements of the Government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY19 funding opportunity will be initially funded with FY19 funds, which will expire for use on September 30, 2025. Exercise of the options for continued performance is contingent upon receipt of sufficient Congressional appropriations for the KCRP in FY20 and FY21, with anticipated funds expiring for use on September 30, 2026 and September 30, 2027, respectively. Awards will be made no later than September 30, 2020. For additional information refer to Section II.F.1, Federal Award Notices. The types of awards made under the Program Announcement will be assistance agreements (grants or cooperative agreements). The level of involvement on the part of the DoD during project performance is the key factor in determining whether to award a grant or cooperative agreement.
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: CDMRP Help Desk &lt;br/&gt;Phone: 301-682-5507 &lt;br/&gt;Email: help@eBRAP.org