ISSN: 2167-0870
Department of Statistics and Decision Sciences, R&D, Janssen Pharmaceutical KK, Tokyo, Japan
Dr. Tomoyoshi Hatayama is currently working in Department of Statistics and Decision Sciences, R&D, Janssen Pharmaceutical KK, Tokyo, Japan. He has published numerous research papers and articles in reputed journals and has various other achievements in the related studies. He has extended his valuable service towards the scientific community with his extensive research work.
Short Communication
Perspectives on Central Statistical Monitoring in Risk Based Approach of Clinical Trials
Author(s): Tomoyoshi Hatayama* and Seiichi Yasui
In recent years, Risk-Based Monitoring (RBM) approach has been receiving increased attention as the efficient
method to ensure data quality in clinical trials. In RBM, Central Statistical Monitoring (CSM) has an important role
to monitor the status of operational process in clinical trials and detect its abnormalities. Many of statistical methods
for CSM are proposed so far, but most of those studies are proposed based on somewhat strong assumptions, in
addition, its performance evaluations are not practical in real setting of clinical trials. Authors think that it is still
imperfect to fit them to practical clinical trials. In this article, we focus to clearly articulating the current problems on
CSM and the matters to consider for further consecutive study activities of CSM... View More»
DOI:
10.35248/2167-0870.21.11.450