Renewal of The Mid-America CTSA Consortium (MACC) as a Regional Clinical Center for SIREN

更新中美洲 CTSA 联盟 (MACC) 作为 SIREN 的区域临床中心

• 批准号: 10550446
• 负责人: TOM Paul AUFDERHEIDE
• 金额: $ 47.36万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-01 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10550446
• 关键词: Adult; Agreement; Applications Grants; Budgets; Chicago; Clinical Trials; Clinical Trials Network; Collaborations; Contracts; Educational Curriculum; Emergency Care; Emergency Situation; Enrollment; Faculty; Fellowship; Funding; Goals; Grant; Health; Helicopter; Hospitals; Illinois; Indiana; Infrastructure; Institution; Intervention; Investments; K-Series Research Career Programs; Leadership; Life; Location; Medical center; Medicine; Mentors; Mentorship; Methodist Church; Methods; Patients; Pediatric Hospitals; Performance; Persons; Politics; Population Heterogeneity; Positioning Attribute; Qualifying; Quality of life; Recommendation; Recording of previous events; Research; Research Design; Research Personnel; Retirement; Secure; Site; Social Sciences; Structure; Study Subject; System; Testing; Texas; Time; Training; Underserved Population; United States National Institutes of Health; Universities; Wisconsin; career; clinical care; clinical center; design; dissemination strategy; experience; improved; innovation; medical schools; multidisciplinary; patient retention; recruit; screening; working group

The Mid-America CTSA Consortium (MACC) submits this renewal application to continue as a Regional Clinical Center (RCC) for the “Strategies to Innovate EmeRgENcy Care Clinical Trials” (SIREN) Network (RFA-NS-22-015). Because Dr. Aufderheide (previous Contact PI at the Medical College of Wisconsin [MCW] Hub) has announced his retirement on January 1, 2024, and because his replacement is unknown at the time of grant submission, we propose to transfer the MACC Hub from MCW to the University of Chicago Medicine (UCM) and Contact PI status to David Beiser, MD, MS (UCM) proactively. As recommended by the NIH Project Officer, we are submitting this application as a Renewal, rather than a New application, providing justification for this transfer. The structure of MACC otherwise remains unchanged. Methods: MACC has a proven track record of exemplary patient accrual performance. Despite not having a site within its catchment capable of participating in the HOBIT Trial, MACC is currently tied for 5th highest enroller among 11 Hubs, enrolling 116 subjects (10.0% of total) including 35 subjects (3rd highest) in BOOST-3, 38 subjects (5th highest) in ICECAP, and 43 subjects (6th highest) in C3PO. Patient retention was 98.3% (114/116; 4th highest). This renewal application adds a strategic focus on even greater patient accrual by: 1) investing $10,000/year infrastructure funding in research coordinator support at all 6 MACC sites, 2) a Patient Accrual Liaison (PAL) to proactively identify accrual barriers, 3) rapidly resolving barriers by leveraging CTSA Collaborative Council support, 4) incorporating a Clinical Trial Practicum (entering SIREN patients) into the Clinical Trials Fellowship (CTF) to augment patient accrual, 5) adding 7 new ED expansion sites and 196,455 potential patients/year, and 6) securing an additional $1.71 Million of institutional funds for SIREN. The UCM research team, experienced in supervising Spokes, and the Center for Health and the Social Sciences, experienced in subcontract management, are strong assets. The CTF provides targeted curriculum, over 20% protected time, a Clinical Trial Practicum, K Award submission post completion, and an additional $50,000 institutional funding to train 3, 2- year fellows. All MACC sites agree to continue Reliance and Master Contract Agreements. With a Hub, 5 Spokes, 3 EMS, 4 helicopter systems, catchment of 9,931,200 people, 110,598 potential patients/year, 190 multi- disciplinary collaborators, expansion capacity of 23 adult, 5 pediatric hospitals, and 2 EMS systems, 46 research personnel, 24/7 coverage at all sites, a strategic patient accrual plan, and proven performance, MACC is well- positioned to achieve SIREN goals. Specific Aims. MACC aims to: 1) Meet/exceed recruitment goals of at least 100 subjects per year, including diverse/underserved populations, 2) Achieve all study milestones and exemplary clinical trial execution, 3) Engage a wide spectrum of investigators, 4) Mentor 3 junior faculty investigators to successful academic careers in emergency clinical trial research, 5) Contribute significantly to SIREN governance, and 6) Promote dissemination of SIREN study findings and stimulate SIREN grant applications.

美国中部CTSA联盟（MACC）提交了此续签申请，以继续作为区域临床中心（RCC）的“创新急诊临床临床试验策略”（Siren）网络（RFA-NS-22-2-015）。因为Aufderheide博士（威斯康星州医学院（MCW] HUB）的先前联系PI）已于2024年1月1日宣布退休，并且由于他的替换在授予时未知，我们建议将MACC HUB从MCW转移到MCW到芝加哥大学医学（UCM），并与Pi Contact Pi Contact Pi contack Pi contact Pi contact Pi to David beissis，MSS MSS M.D David Beis，MSD（UC）。根据NIH项目官员的建议，我们将此申请提交为续签，而不是新申请，为此转移提供了理由。 MACC的结构否则保持不变。方法：MACC具有示例性患者准确性表现的可靠记录。尽管在其集水区中没有一个能够参加Hobit试验的站点，但MACC目前在11个枢纽中并列第五高的入学者，招募了116名受试者（占总数占10.0％），其中包括35位BOOST 3，在ICECAP中的38名受试者（第5名）中，iCecap中的38位受试者（第5名）和43名受试者（6th fieee）（6th fixt）。患者保留率为98.3％（114/116；第四高）。 This renewal application adds a strategic focus on even greater patient accuracy by: 1) investing $10,000/year infrastructure funding in research coordinator support at all 6 MACC sites, 2) a Patient Accrual Liaison (PAL) to proactively identify accrual barriers, 3) rapidly resolving barriers by leveraging CTSA Collaborative Council support, 4) incorporating a Clinical Trial Practical (entering SIREN patients) into the临床试验奖学金（CTF）增强患者的核心，5）增加7个新的ED扩展现场和196,455名潜在患者，以及6）额外获得171万美元的机构资金。在监督辐条方面经验丰富的UCM研究团队，分包管理中经验丰富的卫生与社会科学中心是强大的资产。 CTF提供有针对性的课程，超过20％的受保护时间，临床试验实践，K奖励提交后完成以及额外的50,000美元的机构资金，用于培训3，2岁的家伙。所有MACC站点都同意继续依赖和总合同协议。 With a Hub, 5 Spokes, 3 EMS, 4 helicopter systems, catchment of 9,931,200 people, 110,598 potential patients/year, 190 multi-disciplinary collaborators, expansion capacity of 23 adults, 5 pediatric hospitals, and 2 EMS systems, 46 research personnel, 24/7 coverage at all sites, a strategic patient accral plan, and proven performance, MACC is well-positioned to achieve警笛目标。具体目标。 MACC的目的是：1）每年至少达到/超过招聘目标，包括潜水员/服务不足的人群，2）实现所有研究里程碑和示例性临床试验执行，3）参与研究人员，4）指导者3初级教师研究人员在紧急临床研究中成功地促进了Sirnition Sirnition和6）促进Sirnity Sirnition sirnity sirnials Sirens，6）6）赠款申请。