Integrating Biological Markers into Clinical Research

描述（由申请人提供）：这个修订后的K24中期职业研究者奖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）职业生涯的下一个合乎逻辑的步骤。K24将帮助我加强对POR早期职业医学博士研究人员的指导，并提高我在解决NIMH战略计划优先转化研究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），已经提出了关于生物标志物在预测治疗结果中的作用的重要问题。因此，对职业生涯中期的干预研究人员进行培训，使他们能够将生物标志物纳入临床试验，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，并将提高我有效指导医学博士初级临床研究人员的能力，他们专注于疾病的生物学基础和药理学干预。在此K24应用程序中，我建议参加相关课程（例如，精神药理学，行为内分泌学），完成“动手”实验室工作，并在这一领域进行新的研究。这个K24应用程序的具体目标是：1）招募和指导初级研究人员，特别是医学博士，在POR; 2）提高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）将这些技能应用于研究唾液皮质醇和α淀粉酶水平和/或它们的相互作用的创新研究中：a）区分治疗应答者、无应答者和健康对照（N = 180），和B）前瞻性地预测病症的缓解或复发。该研究有效地利用了NIMH的资金和资源，提出了一个“附加”研究，以PI NIMH资助的R 01名为“儿童/青少年焦虑多模式扩展长期研究”（CAMELS，金斯伯格，PI），这是一个为期五年的前瞻性随访研究，焦虑的青少年最初随机在儿童/青少年焦虑多模式研究（CAMS）。

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).