Improved methods to assess the comparative safety of new psychiatric medications

评估新精神科药物相对安全性的改进方法

• 批准号: 9069515
• 负责人: Krista F Huybrechts
• 金额: $ 17.65万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-01 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9069515
• 关键词: Address; Administrative Supplement; Applied Research; Benefits and Risks; Characteristics; Code; Community Healthcare; Complement; Computerized Medical Record; Confounding Factors (Epidemiology); Data; Databases; Detection; Development; Drug Approval; Drug Interactions; Drug usage; Ear; Effectiveness; Electronics; Ensure; Epidemiologic Methods; Epidemiologic Studies; Epidemiologist; Faculty; Foundations; Funding; Future; Goals; Grant; Health; Health Personnel; Health Services Research; Healthcare; Hospitals; Knowledge; Life Cycle Stages; Link; Marketing; Measures; Medical; Medicine; Mental Health; Mental disorders; Mentors; Methods; Monitor; National Institute of Mental Health; Natural Language Processing; Observational Study; Outcome; Patients; Performance; Pharmaceutical Economics; Pharmaceutical Preparations; Pharmacoepidemiology; Pharmacotherapy; Phase III Clinical Trials; Pilot Projects; Placebos; Play; Policies; Population; Psychiatric therapeutic procedure; Psychiatrist; Psychiatry; Psychopharmacology; Psychotropic Drugs; Public Health; Reporting; Research; Research Design; Research Personnel; Research Priority; Role; Safety; Strategic Planning; Subgroup; System; Time; Training; Woman; Work; base; career; career development; clinical practice; cohort; comparative; disorder risk; effectiveness research; evidence base; experience; health application; health care service utilization; improved; instructor; medical schools; member; method development; novel therapeutics; post-market; prospective; prototype; routine care; skills

DESCRIPTION (provided by applicant): I am an epidemiologist and junior faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham & Women's Hospital, and Instructor in Medicine at Harvard Medical School. My long term goal is to establish a career as an independent investigator in psychiatric pharmacoepidemiology. As new mental health products move from the highly-controlled pre-marketing setting into clinical practice, comparative safety and effectiveness information is required to inform optimal prescribing and policy decisions. Phase 3 trials usually do not provide sufficient evidence to inform these decisions due to their relatively narrow focus on efficacy defined as statistical superiority over placebo. Observational studies using electronic health- care data play a critical role in generating comparative information in routine care, but are typically conducted long after a drug has entered the market, and therefore can fail to identify serious safety issues in the early marketing experience. Prospective monitoring of medical products starting at the time of market entry offers a promising complementary approach to detect concerns as early as possible. Development of methods for use in a prospective monitoring framework for mental health applications is largely uncharted territory. The goal of the proposed research is to develop improved methods for understanding the comparative safety and effectiveness of new psychiatric medications, and is aligned with the priorities of Strategic Objective 3 in the NIMH Strategic Plan. In addition to pursuing training in mental health through coursework, hands-on experience, and close mentoring by a psychiatrist, I will pursue the following research aims: Aim 1: To implement our available monitoring system prototype, and study its applicability to the special characteristics of prescription drugs used in patients with psychiatric illness, using empirical examples. Aim 2: To customize the monitoring system to the methodological challenges that are specific to comparative research in mental health, in particular the study of drug-drug interactions and the use of disease risk scores and instrumental variables to mitigate confounding by measured and unmeasured factors. Aim 3: To explore the feasibility of using electronic medical records and natural language processing analysis to better capture mental health outcomes which are particularly difficult to identify using administrative data codes and to improve confounding control. Aim 4: To implement the new customized system and prospectively monitor the safety of selected mental health treatments newly marketed during the funding period as data accumulate in ear-real-time. Better detection of safety concerns early in the life cycle of mental health drugs is of great public health importance as it may expedite drug approval and make prescribers more comfortable using new drugs by providing a mechanism for ongoing post-marketing safety monitoring. It will also improve the evidence base for mental health providers, and help to contain use of medications with less favorable risk-benefit relations.

描述（由申请人提供）：我是布莱根妇女医院药物流行病学和药物经济学部门的流行病学家和初级教员，也是哈佛医学院的医学讲师。我的长期目标是成为精神病药物流行病学的独立研究者。随着新的精神卫生产品从高度控制的上市前环境进入临床实践，需要比较安全性和有效性信息来为最佳处方和政策决策提供信息。 3 期试验通常不会提供足够的证据来指导这些决定，因为它们相对狭窄地关注功效（定义为相对于安慰剂的统计优势）。使用电子医疗保健数据的观察性研究在生成常规护理中的比较信息方面发挥着关键作用，但通常是在药物进入市场后很长时间才进行，因此可能无法在早期营销经验中识别严重的安全问题。从进入市场时开始对医疗产品进行前瞻性监测提供了一种很有前景的补充方法，可以尽早发现问题。开发用于心理健康应用的前瞻性监测框架的方法在很大程度上是未知领域。拟议研究的目标是开发改进的方法来了解新型精神科药物的相对安全性和有效性，并与 NIMH 战略计划中战略目标 3 的优先事项保持一致。除了通过课程作业、实践经验和精神科医生的密切指导来接受心理健康方面的培训外，我还将追求以下研究目标：目标 1：实施我们现有的监测系统原型，并研究其对特殊特征的适用性使用经验例子对精神疾病患者使用的处方药进行分析。目标 2：根据心理健康比较研究特有的方法学挑战定制监测系统，特别是药物相互作用的研究以及使用疾病风险评分和工具变量来减轻测量和未测量因素的混杂。目标 3：探索使用电子病历和自然语言处理分析的可行性，以更好地捕获使用行政数据代码特别难以识别的心理健康结果，并 改善混杂控制。目标 4：实施新的定制系统，并随着耳朵实时数据积累，前瞻性地监测资助期间新上市的选定心理健康治疗的安全性。在精神卫生药物生命周期的早期更好地检测安全问题对于公共卫生具有重要意义，因为它可以加快药物审批，并通过提供持续的上市后安全监测机制，使处方者更轻松地使用新药。它还将改善心理健康提供者的证据基础，并有助于控制风险收益关系较差的药物的使用。