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Improving the design and statistical analysis of cluster-randomized trials on tropical infectious diseases

改进热带传染病整群随机试验的设计和统计分析

基本信息

批准号：
10570440
负责人：
Bingkai Wang
金额：
$ 9.36万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-05-17 至 2024-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10570440
关键词：
Accounting Address Award Biometry Caring Clinical Research Cluster randomized trial Collaborations Communicable Diseases Complex Cost efficiency Data Data Analyses Dedications Dengue Developing Countries Development Disease Outbreaks Ebola Equation Equipment Evaluation Evaluation Studies Faculty Funding Future Goals Graph Health Care Seeking Behavior Individual Infectious Diseases Research Influenza Intervention Intervention Studies Kenya Malaria Meningitis Mentors Mentorship Methodology Methods Modeling Outcome Pathway interactions Pennsylvania Phase Positioning Attribute Procedures Process Randomized Research Research Personnel Resources Sample Size Statistical Data Interpretation Statistical Methods Statistical Models Symptoms Techniques Testing Training Training Activity Universities Vaccination Wolbachia Work arm career cluster randomized design computerized tools design disorder control experience flexibility hands-on learning improved innovation intervention effect novel pathogen pragmatic trial randomized trial recruit simulation statistics summer institute symposium tenure track theories training opportunity trial design vector control

项目摘要

PROJECT SUMMARY This Pathway to Independence Award application is submitted by a statistician committed to improving the design and analysis of tropical infectious disease cluster-randomized trials (CRTs). Worldwide, hundreds of CRTs are carried out annually to evaluate the effect of new interventions against infectious diseases, especially in tropical developing countries experiencing dengue, Ebola, malaria, and other infectious disease outbreaks. The scientific rigor of these CRTs relies on valid statistical analysis methods that adequately address the complexity in the CRT designs. However, the emergence of CRTs with complex and novel designs has outpaced the development of causal inference methods for data analysis. This gap represents a key barrier to providing valid sample size calculation, efficient estimation, and correct interpretation of the intervention effect estimates. The overarching goal of this research is to surmount this barrier by developing valid, robust, and efficient statistical methods. Specifically, the applicant will address the statistical challenges of three CRT designs: (1) covariate-adaptive randomization, which has been extensively used for reducing baseline imbalance, (2) the test-negative design, which has been increasingly popular in recent years for achieving cost-efficiency, and (3) the multi-arm stepped-wedge design, which has the potential to improve flexibility and efficiency for future CRTs. In the K99 phase, the applicant will extend the empirical process theory to handle covariate-adaptive randomization in CRTs and provide both theoretical and computation evaluations of current statistical models. During the first year of the R00 phase, the applicant will focus on test- negative designs in CRTs and eliminate the bias from differential healthcare-seeking behavior by characterizing the underlying causal graph and performing inference on self-nondiagnosable symptoms. Finally, the applicant will develop an optimal design that can simultaneously handle treatment roll-out, multiple interventions, and various outcome types. The applicant will accomplish the research aims under the mentorship of established researchers in infectious disease, statistics, and biostatistics to assure his transition to a tenure-track faculty position in the R00 phase and his emergence as a leading infectious disease biostatistician. At the University of Pennsylvania, the applicant enjoys rich internal resources of courses, seminars, computational equipment, collaborations, and intellectual interactions with prestigious researchers; furthermore, the applicant has access to external training opportunities including summer institutes, national conferences, and hands-on learning in trial conduct in Kenya. These training activities will propel the research career of the application, thereby supporting his achieving academic independence and ultimately leading a research team to advance the research of infectious diseases.

项目总结