Annual Report 2022

Division of Biostatistical Research

Taro Shibata, Aya Kuchiba

Introduction

 The investigators in the Division of Biostatistical Research develop statistical methods and research methodology, motivated by the statistical problems in the public health research. We collaborate with various divisions in the National Cancer Center, and contribute to better understanding of specific research questions and improving public health through developing and applying statistical methodology. Our expertise in quantitative methods enhances the research platforms by providing advice for formulating research hypotheses, choosing study designs, collecting and managing research data, designing databases, and analyzing data.

 We are closely working with the investigators in the Biostatistics Division, Center for Research Administration and Support.

Research Activities

Methodological Research

• For clinical trials evaluating preventive interventions for adverse events induced by chemotherapy, which can occur in either hand, we proposed a new study design and analysis methods that take into account hand correlations within a subject and published a paper on this topic.

Research Methodology with Registry/Real-World Data

• We are regularly updating information on ongoing clinical trials with the Division of Cancer Information Service by establishing collaborative relationships with other sources of cancer information and the project teams in cancer research.
• As part of the project supported by AMED, we published documents in an academic journal regarding the perspectives on the requirement for reliability of RWD and patient registry data for pharmaceutical approval, as well as the study designs and statistical methods for utilizing RWD. In addition, based on the AMED project’s considerations, comments on the paper that provide an overview of regulatory use of RWD/RWE by the US FDA and industry/academia member were published.

Building and Utilizing Research Platform

• In collaboration with bioinformatic experts in the Division of Bioinformatics, Research Institute, we have established a consultation service for research involving omics data and have commenced offering the service.
• In collaboration with Rare Cancer Center and NCCH, we drafted a document on functions required for “regional rare cancer centers (tentative name)” as part of Ministry of Health, Labour and Welfare Scientific Research Grant project.

Collaborative Research

• We are working on applying causal mediation analysis with a potential outcome framework to get deeper insights into the mechanism of cancer development.
• We are involved in projects on implementation research for quitting smoking from the planning stage.
• We are currently engaging in multiple studies aimed at evaluating the diagnostic performance of support systems for endoscopic diagnosis using artificial intelligence for practice application. Out of these studies, one study has been published in an academic journal.
• We are continuously offering advice on the statistical approaches for various study projects, which include epidemiological studies using biomarkers, research on smoking cessation strategies, and nationwide surveys on health information.

Education

• We organized and provided one-the-job training on social medical research for graduate students studying biostatistics. We are working towards establishing a framework to consistently provide these opportunities as part of the project supported by AMED.

Future Prospects

 Biostatistics has a close connection with real applications. In 2022, we continued to conduct methodological research and collaborative studies in epidemiology, implementation research, and cancer survivorship. In addition, we also worked on strengthening our research foundation by initiating new consultation services with experts in bioinformatics. Furthermore, we introduced internships targeting graduate students studying biostatistics with other divisions of ICC for the first time, expanding efforts to nurture young research talent.

  We endeavor to establish a powerful collaborative relationship with researchers throughout the NCC and contribute to the exploration of critical challenges and issues that the NCC needs to tackle.