Oral Corticosteroid Use During Pregnancy and Risk for Preterm Birth

 描述(申请人提供)：我是加州大学圣地亚哥分校(UCSD)儿科的博士后学者，我正在申请K99/R00独立路径奖，以促进我过渡成为怀孕期间药物安全的独立调查员。我的背景是流行病学，我的职业目标是研究怀孕期间用药对围产期和儿科健康的风险，为妇女和她们的医疗保健提供者必须做出的复杂治疗决定提供信息。为了培养我成为一名独立调查员的能力，我提议进行一项密集的职业发展和研究计划。具体地说，我建议(1)增加我对药理学概念、药物信息和人类畸形学的知识，(2)获得更多使用前瞻性队列和医疗保健利用数据进行研究并将研究结果传播给医疗保健专业人员的经验，以及(3)加强我的拨款撰写技能。我已经组建了一个由5名UCSD教职员工组成的理想团队，为我提供这些领域的指导和指导。我的主要导师克里斯蒂娜·钱伯斯博士是孕期用药安全领域的领导者。我的共同导师是：孕期临床药理学专家布鲁基·贝斯特博士；在健康服务和实践研究方面拥有专长的郭美美博士；利用医疗补助数据进行研究的专家托德·吉尔默博士；以及擅长将生物统计学方法应用于孕期药物研究的徐荣辉博士。这项拟议的研究的目的是为临床决策提供信息，关于妊娠期间口服皮质类固醇与替代疗法治疗哮喘和自身免疫性疾病的比较。我建议对患有哮喘和自身免疫性疾病的孕妇在怀孕期间口服皮质类固醇与早产风险之间的关系进行评估。我将比较口服皮质类固醇和其他治疗方法(例如，吸入皮质类固醇和抗风湿药物)和不治疗。我将使用前瞻性收集的队列数据和医疗保健利用数据来进行这项研究，我将比较和对比这些方法。此外，我将在先前研究的背景下，将结果传播给临床医生。这项拟议的研究是对公共卫生迫切需要关于口服皮质类固醇对早产风险的影响的信息的回应。我将在使用队列和医疗保健利用数据方面培养专业知识，并将获得比较研究方法和开发与药物安全性研究相关的临床应用程序的经验。在这项创新研究的基础上，我将制定一项具有竞争力的R01拨款提案，以继续研究人类安全数据不足的怀孕期间常用药物。

 DESCRIPTION (provided by applicant): I am a postdoctoral scholar in the Department of Pediatrics at the University of California, San Diego (UCSD), and I am applying for the K99/R00 Pathway to Independence Award to facilitate my transition to become an independent investigator of medication safety during pregnancy. My background is in epidemiology and my career goal is to conduct research regarding the risks of medication use during pregnancy on perinatal and pediatric health to inform the complex treatment decisions that women and their health care providers must make. To develop my capacity to become an independent investigator, I am proposing an intensive career development and research program. Specifically, I propose (1) to increase my knowledge of pharmacology concepts, drug information, and human teratology, (2) to gain additional experience conducting studies using prospective cohort and healthcare utilization data and disseminating findings to healthcare professionals, and (3) to strengthen my grant writing skills. I have assembled the ideal team of 5 UCSD faculty members to provide me with guidance and instruction in these areas. My primary mentor, Dr. Christina Chambers, is a leader in the field of medication safety during pregnancy. My co-mentors are: Dr. Brookie Best, an expert in clinical pharmacology during pregnancy; Dr. Grace Kuo who has expertise in health services and practice-based research; Dr. Todd Gilmer, an expert in conducting research with Medicaid data; and Dr. Ronghui Xu, who has expertise in applying biostatistics methods to studies of medication in pregnancy. The objective of the proposed research is to inform clinical decision making regarding oral corticosteroid use versus alternative treatments for asthma and autoimmune diseases during pregnancy. I am proposing to assess the association between oral corticosteroid use during pregnancy and risk for preterm birth among pregnant women with asthma and autoimmune diseases. I will compare oral corticosteroids with alternative treatments (e.g., inhaled corticosteroids and disease modifying antirheumatic drugs) and no treatment. I will use both prospectively collected cohort data and healthcare utilization data to conduct the study, and I will compare and contrast these methodological approaches. Furthermore, I will disseminate the results, within the context of previous research, to clinicians. The proposed study is responsive to the urgent public health need for information regarding the impact of oral corticosteroid use on risk for preterm birth. I will develop expertise in working with cohort and healthcare utilization data, and will gain experience comparing study methodologies and developing clinical applications related to medication safety research. Building on this innovative research, I will develop a competitive R01 grant proposal to pursue studying commonly used medications during pregnancy that have inadequate human safety data.