Integrating Biological Markers into Clinical Research

将生物标记物整合到临床研究中

• 批准号: 9020999
• 负责人: Golda Susan Ginsburg
• 金额: $ 16.2万
• 依托单位: UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-02-25 至 2017-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9020999
• 关键词: Address; Adolescent; Affect; Anxiety; Anxiety Disorders; Applied Skills; Area; Autonomic nervous system; Award; Behavioral; Behavioral inhibition; Biological; Biological Markers; Biological Sciences; 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; responders and non-responders; skills; social; treatment responders

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）：这项修订后的K24中级研究员研究员奖是以患者为导向的研究（POR）是我在约翰·霍普金斯大学（JHU）医学院（SOM）职业生涯的下一个逻辑步骤。 K24将帮助我加强对POR早期医学博士研究人员的指导，并提高我在NIMH战略计划重点的领域的指导和研究技能。具体而言，在小儿焦虑生物学的最新进展（2011年3月）中，关于生物标志物在预测治疗结果中的作用已经提出了重要问题。因此，对中级干预研究人员的培训在使他们能够将生物标记纳入临床试验中的方法中至关重要。扩大我在这一领域的研究技能将使对儿童焦虑领域做出重大贡献，这将增强我有效地指导初级临床医生评估者的能力，他们专注于疾病和药理干预措施的生物学基础。在此K24应用程序中，我建议参加相关课程（例如心理药理学，行为内分泌学），完成“手上”实验室工作，并在该领域进行新颖的研究。该K24应用的具体目的是：1）POR中的招募和导师初级研究人员，尤其是MDS； 2）增强我在心理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线，研究了唾液皮质醇和α淀粉酶和/或它们的相互作用的水平是：a）区分治疗响应者，非反应者和健康的对照（n = 180），以及b）前瞻性预测疾病的缓解或复发。该研究通过提出对PIS NIMH资助的R01的“添加”研究，题为“儿童/青春期/青春期焦虑多模式的长期研究”（Camels，Ginsburg，PI），这是对儿童/青少年焦虑焦虑的焦虑焦虑焦虑研究（Cumscent Coms cums cums coms cums coms cums cams coms com cams compoy coms cocs），这项研究有效地利用了NIMH资金和资源。