Clinical Coordinating Center for the Health Initiative in Early Phase Pain Investigation Clinical Network
早期疼痛调查临床网络健康倡议临床协调中心
基本信息
- 批准号:10246465
- 负责人:
- 金额:$ 196.93万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-09-30 至 2024-08-31
- 项目状态:已结题
- 来源:
- 关键词:Acute PainAdherenceAdoptedAdultAdverse eventAgreementBiologicalBylawChildhoodClinicalClinical DataClinical InvestigatorClinical ResearchClinical TrialsClinical Trials NetworkCollaborationsConceptionsContractsData Coordinating CenterDevelopmentEnsureFosteringFoundationsGoalsHealthIndividualIndustryInformation TechnologyInfrastructureInstitutional Review BoardsInterventionJointsLaboratoriesLeadLeadershipLogisticsMentorshipMethodologyMonitorMulti-Institutional Clinical TrialMulticenter TrialsNeurobiologyNeurosciencesOutcome MeasurePainParticipantPatient RecruitmentsPatientsPharmacy facilityPhasePhase II Clinical TrialsPhenotypePopulationPrincipal InvestigatorProceduresProcessProtocols documentationReportingResearchResourcesSiteSocietiesStandardizationTrainingTraining ProgramsTraining and EducationTranslatingWorkbiomarker validationchronic painclinical investigationdata managementdesigndigitalexperiencehuman subject protectionimplementation measuresimprovedinnovationmultidisciplinarynovelorganizational structurepatient populationperformance siteprotocol developmentquality assurancerecruittooltreatment responsevalidation studies
项目摘要
Project Summary
The objective of the Early Phase Pain Investigation Clinical Network (EPPIC-Net) and EPPIC-
Net initiatives is to rapidly and efficiently translate advances in the neurobiology of pain into
treatments for people with chronic and acute pain, conditions associated with a significant
burden to both patients and society. Challenges to the successful and efficient development of
novel treatments for people with pain include inefficiencies in regulatory and institutional
submissions and approvals, a variety of barriers to recruitment of subjects that slow down
clinical research, inadequate quality assurance of trials, and a shortage of individuals trained
and prepared to participate in and lead multicenter trials. The primary goal of the Clinical
Coordinating Center (CCC) for EPPIC-Net is to promote and facilitate, from initial conception
through final analysis, clinical trials in adult and pediatric populations with acute or chronic pain
by providing efficient methodological, organizational and logistical support. The EPPIC-Net-CCC
will adopt and establish processes aimed at dramatically increasing the efficiency of multicenter
clinical trials, improving the overall quality of clinical trials, promoting patient recruitment and
retention as well as increasing the number of clinical investigators and research staff well
trained and passionate about leading and conducting multicenter clinical trials. The Specific Aim
1 of our proposal is to harness through a collaborative Clinical Coordinating Center
multidisciplinary clinical research and data management expertise to provide the scientific
leadership and infrastructure required to design and conduct multi-site Phase 2 clinical trials,
biomarker validation studies, and deep phenotyping of patient populations to understand the
biologic basis of a specific pain condition and its response to treatment. The Specific Aim 2 of
our proposal is to expand the pool of experienced clinical Investigators and research staff to be
participants and leaders of multicenter clinical research trials by providing education, training,
resources and professional mentorship. Finally, the Specific Aim 3 of our proposal is to engage
and mobilize federal, industry, foundations and patient partners by working with the EPPIC-Net
Steering Committee (EPPIC-Net-SC), EPPIC-Net-DCC and Project Team Principal
Investigators to conduct multi-site Phase 2 clinical trials, biomarker validation studies, and deep
phenotyping of patient populations to understand the biologic basis of a specific pain condition
and its response to treatment.
项目摘要
早期疼痛研究临床网络(EPPIC-Net)和EPPIC-
Net倡议是快速有效地将疼痛神经生物学的进展转化为
治疗慢性和急性疼痛的人,与显着相关的条件
给患者和社会带来负担。成功和高效率地发展
疼痛患者的新疗法包括监管和制度方面的效率低下,
提交和批准,招募受试者的各种障碍,
临床研究,试验质量保证不足,缺乏训练有素的人员
并准备参与和领导多中心试验。临床的主要目标
EPPIC网络协调中心(CCC)从最初的概念开始,
通过最终分析,在患有急性或慢性疼痛的成人和儿童人群中进行的临床试验
提供有效的方法、组织和后勤支持。EPPIC-网络-CCC
将采用和建立旨在大幅提高多中心效率的流程,
临床试验,提高临床试验的整体质量,促进患者招募,
保留以及增加临床研究者和研究人员的数量
受过培训,对领导和开展多中心临床试验充满热情。具体目标
我们的建议之一是通过合作临床协调中心
多学科临床研究和数据管理专业知识,
设计和开展多中心II期临床试验所需的领导力和基础设施,
生物标志物验证研究和患者人群的深度表型分析,以了解
特定疼痛状况的生物学基础及其对治疗的反应。具体目标2
我们的建议是扩大有经验的临床研究者和研究人员的库,
通过提供教育,培训,
资源和专业指导。最后,我们建议的具体目标3是
通过与EPPIC网络合作,动员联邦、行业、基金会和患者合作伙伴
指导委员会(EPPIC-Net-SC)、EPPIC-Net-DCC和项目组负责人
研究者将进行多中心II期临床试验、生物标志物验证研究和深入研究。
对患者人群进行表型分析,以了解特定疼痛状况的生物学基础
以及对治疗的反应
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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ROBERT R EDWARDS的其他文献
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{{ truncateString('ROBERT R EDWARDS', 18)}}的其他基金
Sensory Phenotyping to Enhance Neuropathic Pain Drug Development
感觉表型增强神经病理性疼痛药物的开发
- 批准号:
10724809 - 财政年份:2023
- 资助金额:
$ 196.93万 - 项目类别:
Impact of Theory of Mind Training on Brain-to-Brain Patient-Clinician Concordance
心理理论训练对脑-脑患者-临床医生一致性的影响
- 批准号:
10544363 - 财政年份:2023
- 资助金额:
$ 196.93万 - 项目类别:
Mentorship in precision pain medicine via EPPIC-NET
通过 EPPIC-NET 进行精准疼痛医学指导
- 批准号:
10426787 - 财政年份:2021
- 资助金额:
$ 196.93万 - 项目类别:
Clinical Coordinating Center for the Health Initiative in Early Phase Pain Investigation Clinical Network
早期疼痛调查临床网络健康倡议临床协调中心
- 批准号:
10703234 - 财政年份:2019
- 资助金额:
$ 196.93万 - 项目类别:
Clinical Coordinating Center for the Health Initiative in Early Phase Pain Investigation Clinical Network
早期疼痛调查临床网络健康倡议临床协调中心
- 批准号:
10480912 - 财政年份:2019
- 资助金额:
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Opioid-induced change in pain sensitivity and modulation: Links to opioid misuse
阿片类药物引起的疼痛敏感性和调节变化:与阿片类药物滥用的联系
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9035522 - 财政年份:2016
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Brain Mechanisms Underlying CBT-Related Reductions in Fibromyalgia
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Brain Mechanisms Underlying CBT-Related Reductions in Fibromyalgia
CBT 相关减少纤维肌痛的大脑机制
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8631674 - 财政年份:2014
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Young Investigator Travel Support for 2013 APS Annual Scientific Meeting
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- 批准号:
8101280 - 财政年份:2010
- 资助金额:
$ 196.93万 - 项目类别:
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