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 “Consortium”). 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’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’ role in the committee should be independent of their employment with a participating institution. During the Consortium’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: ○ Adherence to the responsibilities delineated below for a Clinical Trial Site. ○ Coordination and facilitation of at least two open clinical trials at all times after the first 6 months of the performance period. ○ Development and maintenance of the Consortium organizational structure. ○ 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. ○ Management of Consortium-developed procedures for review, selection, and implementation of clinical trials proposed by or through Consortium members. ○ 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. ○ Establishment and management of procedures for ensuring compliance with U.S. Food and Drug Administration (FDA) requirements for investigational agents, devices, and procedures. ○ Establishment and management of a communications plan and an ongoing communications system between the Coordinating Center and Clinical Trial Sites. ○ Management of Consortium-developed quality assurance and quality control mechanisms for study monitoring, including: − Real-time and remote monitoring program − 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 − Registration, tracking, and reporting of participant accrual − Timely medical review and assessment of participant data − Rapid reporting and communication of adverse events − Interim evaluation and consideration of measures of outcome ○ 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. ○ Development of statistical plans for all Consortium clinical trials. ○ Management of Consortium-developed intellectual and material property issues among institutions participating in the Consortium. ○ Management of Consortium-developed procedures for the timely publication of major findings and other public dissemination of data. ○ Development and execution of plans for ongoing review by the Consortium’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: ○ 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. ○ 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 submiss

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