Collaborative for REsearch to Advance TMD Evidence (CREATE)

推进 TMD 证据的研究合作 (CREATE)

基本信息

批准号：
10828983
负责人：
Alejandro Jose Almarza
金额：
$ 27.22万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-05 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10828983
关键词：
Academy Advocate Basic Science Caring Center for Translational Science Activities Clinical Clinical Research Collection Consensus Data Development Dissemination and Implementation Education Education and Outreach Ensure Evaluation Evidence based treatment FAIR principles Feedback Focus Groups Funding Future Goals Health Personnel Healthcare Human Human Resources Individual Industry Infrastructure Investments Knowledge Lead Leadership Link Orofacial Pain Pain Patient-Focused Outcomes Patients Persons Phase Phenotype Policies Pre-Clinical Model Procedures Process Professional Organizations Protocols documentation Reporting Research Research Infrastructure Research Personnel Resources Risk Assessment Schedule Site Specificity Technology Temporomandibular Joint Disorders Temporomandibular joint disorder pain Therapeutic Intervention Tissue Banks Training and Infrastructure Translational Research Translations United States United States Food and Drug Administration Validation Vision Work bench to bedside clinical center clinical phenotype clinical translation data exchange data repository disorder prevention disorder subtype evidence base improved innovation knowledge integration novel diagnostics novel therapeutics patient oriented patient response phenotypic data pre-clinical pre-clinical assessment pre-clinical research preclinical study predictive marker prevent programs prospective recruit repository infrastructure research data dissemination safety testing shared repository success translational approach translational impact translational pipeline working group

项目摘要

We propose to finally bridge the gap in our understanding of the relationship between temporomandibular disorder (TMD) pain and underlying mechanisms, which will provide new diagnostics and therapeutics for TMD patients. We envision that the TMD Collaborative for Improving Patient-Centered Translational Research (TMD IMPACT) will address the need for: TMD prevention, the development of effective and personalized TMD therapies, and expanding the current work force of those researching and managing TMD pain by taking a bidirectional translational approach. Our vision for TMD IMPACT involves five key components: 1) a Clinical Phenotyping Core responsible for Clinical Centers across the US, to coordinate patient assessment and analyses, ensure clinical studies include whole-person evaluations of individuals with a TMD, the collection of phenotypic data that will be used to identify TMD subtypes and biomarkers predictive of underlying mechanisms, and patient outcomes and response to therapeutic interventions; 2) a Preclinical Core responsible for the validation of preclinical models, establishing causal links between mechanisms and pain phenotypes, and for the initial efficacy, specificity, and safety testing of therapeutic interventions; 3) a Data and Biospecimen Management Core that will coordinate the integration of different data types and storage of biospecimens, such that TMD IMPACT resources follow FAIR principles and provide long-lasting impacts on TMD research into the future; 4) an Education and Outreach Core to build scientific and clinical workforce capacity, thereby increasing the number of programs pursuing preclinical and clinical TMD research, expanding the availability of evidence-based care for people living with a TMD, and promoting dissemination and implementation of advances made by the Collaborative; and 5) a Stakeholder Group consisting of patients/patient advocates, payers, and industry representatives who will provide feedback on all Collaborative efforts. During the proposed planning phase, our Collaborative for REsearch to Advance TMD Evidence (CREATE) team will work with the other selected teams to lay the groundwork needed to establish the TMD-Collaborative and achieve a shared vision for TMD-IMPACT. Our general strategy will be to engage with funded sites and centers chosen for the TMD-IMPACT planning phase, as they will have expertise and infrastructure relevant to the four core components of the Collaborative.

我们建议最终弥合我们对之间关系之间关系的差距颞下颌疾病（TMD）疼痛和潜在机制，这将提供新的 TMD患者的诊断和治疗疗法。我们设想TMD合作改善以患者为中心的转化研究（TMD影响）将满足以下需求： TMD预防，有效和个性化的TMD疗法的开发以及扩展通过双向研究和管理TMD疼痛的人的当前劳动力翻译方法。我们对TMD影响的愿景涉及五个关键组成部分：1）临床负责美国临床中心的表型核心，以协调患者评估和分析，确保临床研究包括对具有TMD的个体，该表型数据的收集将用于识别TMD 亚型和生物标志物可以预测基本机制，患者结果和对治疗干预措施的反应； 2）负责验证的临床前核心临床前模型，建立机制和疼痛表型之间的因果关系，以及治疗干预措施的初始功效，特异性和安全性测试； 3）数据和生物测量管理核心将协调不同数据类型和的集成生物测量的存储，使得TMD影响资源遵循公平的原则并提供对未来的TMD研究的长期影响； 4）教育和外展核心建立科学和临床劳动力能力，从而增加计划的数量追求临床前和临床TMD研究，扩大基于证据的可用性照顾患有TMD的人，并促进传播和实施协作型的进步； 5）由患者/患者组成的利益相关者组倡导者，付款人和行业代表将提供有关所有协作的反馈努力。在拟议的计划阶段，我们的研究合作促进了TMD 证据（创建）团队将与其他选定的团队合作，为所需的基础奠定基础建立TMD合并剂并实现TMD影响的共同愿景。我们的将军策略将与为TMD Impact计划选择的资金站点和中心互动阶段，因为它们将具有与四个核心组成部分相关的专业知识和基础架构协作。