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Mentoring Patient-Oriented Pharmacoepidemiologic Research in Rheumatic Diseases

指导以患者为导向的风湿性疾病药物流行病学研究

基本信息

批准号：
10187754
负责人：
Seoyoung Catherine Kim
金额：
$ 16.64万
依托单位：
BRIGHAM AND WOMEN'S HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-04-01 至 2026-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10187754
关键词：
Affect Age Award Benefits and Risks Biological Biological Availability Biological Factors Cardiovascular Diseases Characteristics Chronic Client satisfaction Clinical Clinical Investigator Clinical Practice Guideline Clinical Research Clinical Trials Clinical effectiveness Computerized Medical Record Data Decision Making Development Diabetes Mellitus Disease Disease remission Disease-Modifying Second-Line Drugs Drug usage Effectiveness Enrollment Environment Event Evidence based treatment Feedback Future Future Generations Grant Head Heart failure Hospitals Immune system Infection Inflammation Inflammatory Arthritis Interleukins Intestinal Perforation Janus kinase Knowledge Link Malignant Neoplasms Medical Medicare Mentors Meta-Analysis Methods Methotrexate Mid-Career Clinical Scientist Award (K24)Midcareer Investigator Award in Patient-Oriented Research Opioid Outcome Outcomes Research Patient Preferences Patient risk Patients Pharmaceutical Preparations Pharmacoepidemiology Pharmacotherapy Physicians Population Postdoctoral Fellow Randomized Research Research Personnel Research Project Grants Research Training Resources Rheumatism Rheumatoid Arthritis Rheumatology Risk Risk-Benefit Assessment Safety Societies Socioeconomic Status Steroids T-Lymphocyte TNF gene Thrombosis Training Training Programs Woman career clinical development comparative effectiveness comparative safety compare effectiveness evidence base evidence based guidelines experimental study head-to-head comparison health plan illness length improved individual patient inhibitor/antagonist innovation male neglect next generation patient oriented patient oriented research pre-doctoral predictive modeling preference programs rheumatologist safety outcomes side effect skills subcutaneous

项目摘要

PROJECT SUMMARY Rheumatoid arthritis (RA) is a chronic inflammatory arthritis for which there is no known cure. However, with medical breakthroughs in the past few decades, a dozen different biologic and targeted synthetic (ts) disease- modifying antirheumatic drugs (DMARDs) directed toward specific components of the immune system are currently available for patients with moderate-to-severe RA. While all these biologic and ts-DMARDs are highly effective in controlling inflammation in RA, these agents carry a wide range of safety concerns including infections, cardiovascular disease, thrombosis, heart failure, lower intestinal perforations, and malignancies. Given the significantly expanded armamentarium for RA and increasing emphasis on treating to target to achieve remission or low RA disease activity, it is important for both clinicians and patients to understand the data regarding drug effectiveness and safety. However, there is a knowledge gap in concerning how one can compare directly across these different DMARDs with regard to their benefits and risks in the absence of clinical trials. Moreover, few studies have quantitatively assessed and incorporated patient preferences into weighing benefits vs. harms of these drugs. The applicant, therefore, proposes a 5-year K24 award project with three specific research aims which will: 1) emulate a target trial to evaluate head-to-head comparative effectiveness and safety of biologic and ts-DMARDs in patients with RA using real-world data; 2) identify important predictors of safety events associated with use of biologic or ts-DMARDs; and 3) conduct a patient-centered benefit-risk assessment of these drugs incorporating patients’ relative treatment preferences. In addition, the applicant aims to grow and strengthen a research training program in pharmacoepidemiology and patient-oriented outcome research in rheumatic diseases. The applicant, Dr. Seoyoung C. Kim, is a rheumatologist and a doctoral trained pharmacoepidemiologist. She has served as primary or secondary research mentor for over 30 pre- and post- doctoral research trainees in the past decade. The applicant’s many ongoing research projects for pharmacoepidemiologic and patient-oriented research, high degree of commitment to mentoring, and the exceptional institutional resources will provide an outstanding environment for the development of junior investigators. Furthermore, the applicant has assembled a strong team of highly qualified collaborators who can serve as co-mentors for her trainees, and she will continue to refine her mentoring program and skills using trainee feedback during the award period. This K24 award study will help generate real-world evidence-based recommendations for the management of RA with biologic and ts-DMARDs, incorporating patients’ treatment preferences and support the applicant’s ability to build a strong clinical research platform to mentor the next generation of clinical researchers in pharmacoepidemiology and patient-oriented research in rheumatology and promote their successful transition to independence.

项目总结