Integrating Biological Markers into Clinical Research

描述(由申请人提供)：这个修订的K24以患者为中心的研究(POR)职业中期研究员奖是我在约翰霍普金斯大学(JHU)医学院(SOM)职业生涯的下一个合乎逻辑的步骤。K24将帮助我加强对POR中职业生涯早期MD调查人员的指导，并在满足NIMH战略计划翻译研究优先事项的领域提高我的指导和研究技能。具体地说，鉴于儿科焦虑症生物学的最新进展(2011年3月)，提出了关于生物标记物在预测治疗结果中的作用的重要问题。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纳入临床试验，这是至关重要和及时的。拓宽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，这将增强我有效指导初级临床医生-研究MD的能力，他们专注于疾病的生物学基础和药物干预。在这份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“动手”的实验室工作，并在这一领域进行新的研究。K24应用程序的具体目标是：1)招募和指导POR方面的初级研究员，特别是MD；2)增强我在精神药理学和焦虑生物标记物方面的指导和研究技能；3)将这些技能应用于一项创新的研究系列，考察唾液皮质醇和α淀粉酶水平和/或它们之间的相互作用：a)区分治疗应答者、无应答者和健康对照组(N=180)，以及b)前瞻性地预测疾病的缓解或复发。这项研究有效地利用了NIMH的资金和资源，对由NIMH资助的PIS R01提出了一项名为“儿童/青少年焦虑多模式扩展长期研究”(CAMELS，Ginsburg，Pi)的“附加”研究，这是一项最初在儿童/青少年焦虑多模式研究(CAMS)中随机选取的为期五年的前瞻性跟踪研究。

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).