General considerations for clinical data management of antineoplastic drugs / 中国临床药理学与治疗学

With the enormous resources having been invested in oncology drugs development in China in recent years, the Center for Drug Evaluation (CDE) of National Medical Products Administration has been issuing a number of technical guidelines to further standardize the requirements on implementation and registration of domestic oncology clinical trials. As data is the cornerstone of clinical trials, data integrity and quality will directly decide the outcome of clinical studies. Given the specific characteristics of oncology therapeutic clinical trials, and combined with the clinical data standards established by the Clinical Data Interchange Standards Consortium (CDISC) and the issued industrial guidelines, this article introduces the general considerations of clinical data management for oncology clinical trials, with the aim of emphasizing normative data collection and timely data monitoring to ensure the data quality and reliability of results of the study. This article discusses the impact of complex study design on CRF, design CRF according to CDASH, develop DVP scientifically, rolling submissions and data cut-off.

Data Management and Site-Visit Monitoring of the Multi-Center Registry in the Korean Neonatal Network

The Korean Neonatal Network (KNN), a nationwide prospective registry of very-low-birth-weight (VLBW, < 1,500 g at birth) infants, was launched in April 2013. Data management (DM) and site-visit monitoring (SVM) were crucial in ensuring the quality of the data collected from 55 participating hospitals across the country on 116 clinical variables. We describe the processes and results of DM and SVM performed during the establishment stage of the registry. The DM procedure included automated proof checks, electronic data validation, query creation, query resolution, and revalidation of the corrected data. SVM included SVM team organization, identification of unregistered cases, source document verification, and post-visit report production. By March 31, 2015, 4,063 VLBW infants were registered and 1,693 queries were produced. Of these, 1,629 queries were resolved and 64 queries remain unresolved. By November 28, 2014, 52 participating hospitals were visited, with 136 site-visits completed since April 2013. Each participating hospital was visited biannually. DM and SVM were performed to ensure the quality of the data collected for the KNN registry. Our experience with DM and SVM can be applied for similar multi-center registries with large numbers of participating centers.

Conduction of a Large-Scale Clinical Trial for a HMG-CoA Reductase Inhibitor / 薬剤疫学

A large-scale randomized prospective intervention study (Mega Study) was initiated by Ministry of Health and Welfare (MHW) Japan in 1993, and is on going with support from Sankyo Co., Ltd. This study is designed to test the hypothesis that reduction of serum cholesterol with pravastatin (a HMG-CoA reductase inhibitor) over an average of 5 years will reduce the incidence of fatal and nonfatal CHD (Coronary Heart Disease).<BR>As a CRO (Contract Research Organization), we have set up a data center that is responsible for the conduction of this study. The main functions of the data center are to do patient registration, treatment randomization, clinical monitoring, data management, and statistical analysis.<BR>This report outlines our some experiences with conduction of the data center, particularly relating to clinical monitoring, clinical data management, QA (Quality Assurance), and computer systems for such a data center.