Multidisciplinary Clinical Research and Mentoring in Tuberculosis Diagnostics
结核病诊断的多学科临床研究和指导
基本信息
- 批准号:8891560
- 负责人:
- 金额:$ 16.03万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2015
- 资助国家:美国
- 起止时间:2015-02-13 至 2020-01-31
- 项目状态:已结题
- 来源:
- 关键词:AIDS clinical trial groupAcquired Immunodeficiency SyndromeAddressAreaAwardBacterial Drug ResistanceBaltimoreBasic ScienceBioethicsCardiovascular DiseasesCenters for Disease Control and Prevention (U.S.)Cessation of lifeCitiesClinicalClinical DataClinical ManagementClinical ResearchClinical TrialsCollaborationsCommunicable DiseasesComputerized Medical RecordData CollectionDiabetes MellitusDiagnosisDiagnosticDiagnostics ResearchDrug resistance in tuberculosisEffectivenessEpidemiologic StudiesFoundationsFundingFutureGap JunctionsGoalsHIVHealthHealth ProfessionalHealth systemHealthcare SystemsInstitutesInternationalInterventionInterviewInvestmentsKnowledgeLaboratoriesLeadLeadershipLondonMedical ResearchMentorsMentorshipModelingMonitorNational Institute of Allergy and Infectious DiseaseOutcomePharmaceutical PreparationsPhasePhysician ExecutivesPhysiciansProcessPublic HealthPublic Health PracticePublic Health SchoolsPulmonary TuberculosisRandomizedRandomized Clinical TrialsRegimenReportingResearchResearch ActivityResearch PersonnelRoleServicesSystemTherapeuticTherapeutic TrialsTimeTrainingTranslatingTranslational ResearchTranslationsTuberculosisUncertaintyUnited States National Institutes of HealthUniversitiesWorkbasecareercareer developmentclinical practicecollaboratorycollegedesigndiagnostic accuracydrug efficacydrug testingexperienceglobal healthhealth care deliveryinterestmultidisciplinarynext generationnovel diagnosticspatient orientedpatient oriented researchpragmatic trialprofessorprogramspublic health relevanceresearch to practicerifapentineroutine practiceskillssystems researchtooltreatment as usualtreatment durationtuberculosis treatment
项目摘要
DESCRIPTION (provided by applicant): Bacterial drug resistance and HIV continue to threaten control of tuberculosis, a communicable disease responsible for well over one million deaths annually [41]. However, after decades of stasis, recent investment in tuberculosis basic science research has resulted in the emergence of new drugs and diagnostics. Critical challenges and opportunities lie in translating recent research advances and new tools into tuberculosis public health practice; historically the tuberculosis field has been vexingly slow in this regard. Pragmatic clinical trials are a promising mechanism to address this challenge [3]. Specifically, pragmatic trials will help to understand the effectiveness of new interventions under
usual-care conditions, and to disseminate to practitioners and programs experience with those interventions. Pragmatic clinical trials may be particularly well-suited to tuberculosis, in which centralized clinical data collection and outcome reporting are programmatic norms - this is analogous to how electronic medical record systems are facilitating conduct of pragmatic trials in diabetes, cardiovascular disease, and other health fields. While the idea of pragmatic trials in
tuberculosis is not entirely new, to date there has been no focused, systematic exploration of the design of tuberculosis pragmatic trials, regulatory facets of tuberculosis pragmatic trials, an strategies for pragmatic trial implementation across a variety of settings and research questions. The career development goal of this K24 proposal is to expand my knowledge of pragmatic trials, to systematically explore facets of the design and implementation of tuberculosis pragmatic trials, and to design and obtain funding for one or more large pragmatic trials in tuberculosis treatment or diagnosis.
Our team's patient-oriented tuberculosis research, which will be the context for mentoring under this K24, is focused on explanatory clinical trials of tuberculosis therapeutics and diagnostics - that is, whether new drugs and tests work under ideal conditions. Much of this work is done in the context of research consortia in which I have leadership roles. I serve as a PI of the NIH/NIAID Tuberculosis Clinical Diagnostics Research Consortium (TB-CDRC), and lead phase 2 and phase 3 therapeutics trials within the CDC Tuberculosis Trials Consortium (TBTC). Our work in these consortia has been at the vanguard of implementation of highly quality monitored, strictly implemented clinical studies (including laboratory components) intended to produce results with the highest possible internal validity. A detailed understanding of tuberculosis clinical trials, along with knowledge and experience in tuberculosis public health program work, provides a very strong foundation from which to undertake new research into pragmatic trials aimed at understanding external validity (generalizability) of new tuberculosis interventions.
With respect to mentoring, there is unprecedented opportunity arising from the surge in interest among young health professionals in careers in tuberculosis, HIV, and global health. I have a strong track record in mentoring, including having mentored one infectious disease physician through a successful NIH K23 project and on to independent R01 funding. K24 funding will provide protected time for expansion of mentoring activities.
This K24 proposal lies at the nexus of the needs and opportunities for translating tuberculosis research into practice and for training the next generation of investigators in patient-oriented research in tuberculosis. The specific aims are:
Aim 1: To directly mentor junior investigators in patient-oriented research in tuberculosis. Mentorship will be principally in the context of research consortia in which I have leadership roles (NIH Tuberculosis Clinical Diagnostics Research Consortium and CDC Tuberculosis Trials Consortium). Junior investigators will be mentored as they take on roles within main consortium studies and/or lead smaller add-on projects that leverage ongoing consortium activities.
Aim 2: To develop and implement a model for mentoring within clinical research consortia. Initial work will focus on developing and implementing a mentoring program within the Tuberculosis Clinical Diagnostics Research Consortium and Tuberculosis Trials Consortium. A toolkit will be developed, and then used to expand the model to other clinical research consortia, for example the CDC Tuberculosis Epidemiologic Studies Consortium and the NIH AIDS Clinical Trials Consortium.
Aim 3: To build my skills and knowledge in the conduct of pragmatic trials in tuberculosis, in order to conduct future pragmatic trials to assess whether and which new tuberculosis treatments and/or diagnostics work in routine practice. This will be accomplished through interaction with experts in the field of pragmatic trials (Prof. Andrew Nunn and Dr. Jeremy Sugarman), coursework undertaken at Johns Hopkins Bloomberg School of Public Health, engagement in the NIH Health Care Systems Research Collaboratory, and interviews with key stakeholders in the tuberculosis field.
描述(由申请人提供):细菌耐药性和艾滋病毒继续威胁着结核病的控制,结核病是一种传染病,每年导致超过一百万人死亡[41]。然而,经过几十年的停滞之后,最近对结核病基础科学研究的投资导致了新药物和诊断方法的出现。关键的挑战和机遇在于将最新的研究进展和新工具转化为结核病公共卫生实践;历史上,结核病领域在这方面进展缓慢得令人烦恼。实用的临床试验是应对这一挑战的一种有前途的机制[3]。具体而言,务实试验将有助于了解新干预措施的有效性
常规护理条件,并向从业者和项目传播这些干预措施的经验。务实的临床试验可能特别适合结核病,其中集中的临床数据收集和结果报告是程序性规范——这类似于电子病历系统如何促进糖尿病、心血管疾病和其他健康领域的务实试验的进行。虽然务实尝试的想法
结核病并不是全新的,迄今为止,还没有对结核病实用试验的设计、结核病实用试验的监管方面、跨各种环境和研究问题的实用试验实施策略进行集中、系统的探索。本次K24提案的职业发展目标是扩展我对实用性试验的了解,系统地探索结核病实用性试验的设计和实施的各个方面,并为结核病治疗或诊断的一项或多项大型实用性试验设计并获得资金。
我们团队以患者为导向的结核病研究将成为本 K24 指导的背景,重点是结核病治疗和诊断的解释性临床试验,即新药物和测试在理想条件下是否有效。这项工作的大部分是在我担任领导职务的研究联盟的背景下完成的。我担任 NIH/NIAID 结核病临床诊断研究联盟 (TB-CDRC) 的 PI,并领导 CDC 结核病试验联盟 (TBTC) 内的 2 期和 3 期治疗试验。我们在这些联盟中的工作一直处于实施高质量监测、严格实施的临床研究(包括实验室组成部分)的先锋,旨在产生具有尽可能高的内部有效性的结果。对结核病临床试验的详细了解,以及结核病公共卫生规划工作的知识和经验,为开展旨在了解新结核病干预措施的外部有效性(普遍性)的实用试验新研究奠定了坚实的基础。
在指导方面,年轻卫生专业人员对结核病、艾滋病毒和全球卫生职业的兴趣激增,带来了前所未有的机会。我在指导方面拥有良好的记录,包括指导一位传染病医生完成一个成功的 NIH K23 项目,并获得独立的 R01 资助。 K24 资金将为扩大辅导活动提供受保护的时间。
K24 提案涉及将结核病研究转化为实践以及培训下一代研究人员进行以患者为导向的结核病研究的需求和机会。具体目标是:
目标 1:直接指导初级研究人员进行以患者为导向的结核病研究。指导工作将主要在我担任领导职务的研究联盟(NIH 结核病临床诊断研究联盟和 CDC 结核病试验联盟)的背景下进行。初级研究人员在主要联盟研究中发挥作用和/或领导利用正在进行的联盟活动的小型附加项目时将受到指导。
目标 2:开发并实施临床研究联盟内的指导模型。初步工作将侧重于在结核病临床诊断研究联盟和结核病试验联盟内制定和实施指导计划。将开发一个工具包,然后用于将该模型扩展到其他临床研究联盟,例如 CDC 结核病流行病学研究联盟和 NIH 艾滋病临床试验联盟。
目标 3:培养我进行结核病实用试验的技能和知识,以便进行未来的实用试验来评估新的结核病治疗和/或诊断是否以及哪些新的结核病治疗和/或诊断在常规实践中有效。这将通过与实用试验领域的专家(Andrew Nunn 教授和 Jeremy Sugarman 博士)互动、在约翰·霍普金斯大学彭博公共卫生学院开展的课程、参与 NIH 卫生保健系统研究合作实验室以及采访结核病领域的主要利益相关者来完成。
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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Susan E Dorman其他文献
Implications of progressive lung damage and post-tuberculosis sequelae for the health benefits of prompt tuberculosis treatment in high HIV prevalence settings: a mathematical modelling analysis
在艾滋病高流行地区,进行性肺损伤和肺结核后遗症对及时治疗肺结核对健康益处的影响:一项数学模型分析
- DOI:
10.1016/s2214-109x(25)00114-7 - 发表时间:
2025-07-01 - 期刊:
- 影响因子:18.000
- 作者:
Melike Hazal Can;Sedona Sweeney;Brian W Allwood;Susan E Dorman;Ted Cohen;Nicolas A Menzies - 通讯作者:
Nicolas A Menzies
Xpert MTB/RIF Ultra versus mycobacterial growth indicator tube liquid culture for detection of emMycobacterium tuberculosis/em in symptomatic adults: a diagnostic accuracy study
Xpert MTB/RIF Ultra 与分枝杆菌生长指示管液体培养法在有症状成年人中检测结核分枝杆菌/利福平耐药性的比较:一项诊断准确性研究
- DOI:
10.1016/s2666-5247(24)00001-6 - 发表时间:
2024-06-01 - 期刊:
- 影响因子:20.400
- 作者:
Yingda L Xie;Christie Eichberg;Nchimunya Hapeela;Elizabeth Nakabugo;Irene Anyango;Kiranjot Arora;Jeffrey E Korte;Ronald Odero;Judi van Heerden;Widaad Zemanay;Samuel Kennedy;Pamela Nabeta;Mahmud Hanif;Camilla Rodrigues;Alena Skrahina;Wendy Stevens;Reynaldo Dietze;Xin Liu;Jerrold J Ellner;David Alland;Susan E Dorman - 通讯作者:
Susan E Dorman
Susan E Dorman的其他文献
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{{ truncateString('Susan E Dorman', 18)}}的其他基金
Multidisciplinary Clinical Research and Mentoring in Tuberculosis Diagnostics
结核病诊断的多学科临床研究和指导
- 批准号:
9014479 - 财政年份:2015
- 资助金额:
$ 16.03万 - 项目类别:
Multidisciplinary Clinical Research and Mentoring in Tuberculosis Diagnostics
结核病诊断的多学科临床研究和指导
- 批准号:
9586345 - 财政年份:2015
- 资助金额:
$ 16.03万 - 项目类别:
Lipidated Mycobacterium tuberculosis biomarkers in clinical specimens
临床标本中的脂化结核分枝杆菌生物标志物
- 批准号:
8583121 - 财政年份:2013
- 资助金额:
$ 16.03万 - 项目类别:
Lipidated Mycobacterium tuberculosis biomarkers in clinical specimens
临床标本中的脂化结核分枝杆菌生物标志物
- 批准号:
8660620 - 财政年份:2013
- 资助金额:
$ 16.03万 - 项目类别:
Phase II Study of Daily Rifapentine for Pulmonary Tuberculosis (IND 62,611; 1/2/0
每日利福喷丁治疗肺结核的 II 期研究(IND 62,611;1/2/0
- 批准号:
8320752 - 财政年份:2009
- 资助金额:
$ 16.03万 - 项目类别:
Phase II Study of Daily Rifapentine for Pulmonary Tuberculosis (IND 62,611; 1/2/0
每日利福喷丁治疗肺结核的 II 期研究(IND 62,611;1/2/0
- 批准号:
7567947 - 财政年份:2009
- 资助金额:
$ 16.03万 - 项目类别:
Phase II Study of Daily Rifapentine for Pulmonary Tuberculosis (IND 62,611; 1/2/0
每日利福喷丁治疗肺结核的 II 期研究(IND 62,611;1/2/0
- 批准号:
7753247 - 财政年份:2009
- 资助金额:
$ 16.03万 - 项目类别:
Phase II Study of Daily Rifapentine for Pulmonary Tuberculosis (IND 62,611; 1/2/0
每日利福喷丁治疗肺结核的 II 期研究(IND 62,611;1/2/0
- 批准号:
8141454 - 财政年份:2009
- 资助金额:
$ 16.03万 - 项目类别:
Extensively Drug-Resistant Tuberculosis Among Gold Miners in South Africa
南非金矿工人患有广泛耐药结核病
- 批准号:
8111830 - 财政年份:2008
- 资助金额:
$ 16.03万 - 项目类别:
Extensively Drug-Resistant Tuberculosis Among Gold Miners in South Africa
南非金矿工人患有广泛耐药结核病
- 批准号:
8282771 - 财政年份:2008
- 资助金额:
$ 16.03万 - 项目类别:
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