Integrating Biological Markers into Clinical Research

将生物标记物整合到临床研究中

基本信息

批准号：
8955452
负责人：
Golda Susan Ginsburg
金额：
$ 16.32万
依托单位：
UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
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：
2015-02-25 至 2016-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8955452
关键词：
Address Adolescent Affect Anxiety Anxiety Disorders Area Autonomic nervous system Award Behavioral Behavioral inhibition Biological Biological Markers Biology Child Clinical Investigator Clinical Research Clinical Trials Development Disease Disease remission Doctor of Philosophy Endocrinology Follow-Up Studies Funding Future Goals Hand Hydrocortisone Hypothalamic structure Institutes Intervention Intervention Studies Knowledge Laboratories Lead Light Longitudinal Studies Maintenance Measures Mental disorders Mentors Methods National Institute of Mental Health Outcome Pituitary Gland Predictive Value Prospective Studies Psychiatry Psychopharmacology Randomized Recruitment Activity Relapse Reporting Research Research Personnel Research Priority Research Training Resources Role Salivary Sampling School Nursing Strategic Planning Structure Training Translational Research Treatment outcome Trier Social Stress Test Universities Work Youth alpha-amylase anxiety-related disorders anxious base career career development childhood anxiety follow-up innovation interdisciplinary collaboration interest medical schools novel patient oriented patient oriented research personalized medicine programs prospective psychosocial public health relevance skills social

项目摘要

DESCRIPTION (provided by applicant): This revised K24 Mid-Career Investigator Award in Patient-Oriented Research (POR) is the next logical step in my career at The Johns Hopkins University (JHU) School of Medicine (SOM). The K24 will help me enhance my mentoring of early-career MD investigators in POR and advance my mentoring and research skills in areas that address the NIMH Strategic Plan priorities for translational research. Specifically, in light f recent advances in the biology of pediatric anxiety (March, 2011), important questions have been raised about the role of biomarkers in predicting treatment outcomes. The training of mid-career intervention researchers in methods that enable them to integrate biological markers into clinical trials is thus critical and timely. Broadening my research skills in this area will enableme to make a significant contribution to the field of child anxiety and it will enhance my ability to effectively mentor junior clinician-investigators with MDs who focus on the biological bases of illness and pharmacological interventions. In this K24 application, I propose to take relevant courses (e.g., psychopharmacology, behavioral endocrinology), complete "hands on" lab work, and conduct novel research in this area. The specific aims of this K24 application are to: 1) recruit and mentor junior investigators, particularly MDs, in POR; 2) enhance my mentoring and research skills in psychopharmacology and biomarkers of anxiety; and 3) apply these skills in an innovative line of research examining whether levels of salivary cortisol and alpha amylase and/or their interaction: a) differentiate treatment responders, non-responders, and healthy controls (N = 180), and b) prospectively predict remission or relapse of disorder. The study makes efficient use of NIMH funds and resources by proposing an "add on" study to the PIs NIMH-funded R01 entitled "Child/Adolescent Anxiety Multi-modal Extended Long-term Study" (CAMELS, Ginsburg, PI), which is a five year prospective follow-up study of anxious youth initially randomized in the Child/ Adolescent Anxiety Multi-modal Study (CAMS).

描述（由申请人提供）：修订后的 K24 以患者为导向的研究 (POR) 中期职业研究员奖是我在约翰·霍普金斯大学 (JHU) 医学院 (SOM) 职业生涯中的下一个合乎逻辑的步骤。 K24 将帮助我加强对 POR 中早期职业 MD 研究人员的指导，并提高我在涉及 NIMH 战略计划转化研究优先事项的领域的指导和研究技能。具体而言，鉴于儿科焦虑生物学的最新进展（2011 年 3 月），人们对生物标志物在预测治疗结果中的作用提出了重要问题。因此，对职业生涯中期干预研究人员进行培训，使他们能够将生物标记物整合到临床试验中，这一点至关重要且及时。扩大我在这一领域的研究技能将使我能够为儿童焦虑领域做出重大贡献，并将提高我有效指导专注于疾病生物学基础和药物干预的初级临床研究人员和医学博士的能力。在这个K24申请中，我建议学习相关课程（例如精神药理学、行为内分泌学），完成“实践”实验室工作，并在该领域进行新颖的研究。该 K24 申请的具体目标是： 1) 招募和指导初级研究人员，特别是 POR 领域的医学博士； 2）增强我在精神药理学和焦虑生物标志物方面的指导和研究技能； 3) 将这些技能应用于创新的研究中，检查唾液皮质醇和 α 淀粉酶的水平和/或它们的相互作用：a) 区分治疗反应者、无反应者和健康对照 (N = 180)，b) 前瞻性预测疾病的缓解或复发。该研究通过向 NIMH 资助的 R01 的 PI 提出一项题为“儿童/青少年焦虑多模式扩展长期研究”（CAMELS，Ginsburg，PI）的“附加”研究，有效利用了 NIMH 的资金和资源。一项针对焦虑青少年的五年前瞻性随访研究，最初是在儿童/青少年焦虑多模式研究 (CAMS) 中随机进行的。