Review of the registration of clinical trials in UMIN-CTR from 2 June 2005 to 1 June 2010 - focus on Japan domestic, academic clinical trials

Abstract

BackgroundEstablished on 1 June 2005, the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) is the largest clinical trial registry in Japan, and joined the World Health Organization (WHO) registry network in October 2008. Our aim was to understand the registration trend and overall characteristics of Japan domestic, academic (non-industry-funded) clinical trials, which constitute the main body of registrations in UMIN-CTR. In addition, we aimed to investigate the accessibility of clinical trials in UMIN-CTR to people worldwide, as well as the accessibility of clinical trials conducted in Japan but registered abroad to Japanese people in the Japanese language.MethodsWe obtained the data for registrations in UMIN-CTR from the UMIN Center, and extracted Japan domestic, academic clinical trials to analyze their registration trend and overall characteristics. We also investigated how many of the trials registered in UMIN-CTR could be accessed from the International Clinical Trials Registry Platform (ICTRP). Finally, we searched ClinicalTrials.gov for all clinical trials conducted in Japan and investigated how many of them were also registered in Japanese registries. All of the above analyses included clinical trials registered from 2 June 2005 to 1 June 2010.ResultsDuring the period examined, the registration trend showed an obvious peak around September 2005 and rapid growth from April 2009. Of the registered trials, 46.4% adopted a single-arm design, 34.5% used an active control, only 10.9% were disclosed before trial commencement, and 90.0% did not publish any results. Overall, 3,063 of 3,064 clinical trials registered in UMIN-CTR could be accessed from ICTRP. Only 8.7% of all clinical trials conducted in Japan and registered in ClinicalTrials.gov were also registered in Japanese registries.ConclusionsThe International Committee of Medical Journal Editors (ICMJE) announcements about clinical trial registration and the Ethical Guidelines for Clinical Research published by the Japanese government are considered to have promoted clinical trial registration in UMIN-CTR. However, problems associated with trial design, retrospective registration, and publication of trial results need to be addressed in future. Almost all clinical trials registered in UMIN-CTR are accessible to people worldwide through ICTRP. However, many trials conducted in Japan but registered abroad cannot be accessed from Japanese registries in Japanese.

Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013

“…Details on events related to clinical trial registration were mostly derived from Pandey et al, 46 Shiokawa 80 and Tang et al . 48 Data are from our deduplicated data set that was downloaded from the ICTRP. A proportion (15.6%) of registered records of trials was excluded from this data set because the corresponding trials were registered at more than one registry.…”

“…Other local measures that have helped to stimulate trial registration include: enforcement of registration by funders, ethics committees and local journal editors; 46 47 national policies and ethical guidelines that encourage trial registration; 48 and self-regulation by universities 45 and the pharmaceutical industry. 40 Japan and India provide good examples of how clinical trial registration increased when a range of these measures were implemented ( figure 4 ).…”

Twenty‐two years’ experience registering trials in a low‐middle income country: The Peruvian Clinical Trial Registry

“…Both include rules that produce, respectively, the reducing and increasing of restrictions for the performance of RCT. Compared with other registries influenced by new regulations, there were growth trends in Japan's registry between 2004 and 2010, and also in Clinicaltrials.gov between 2005 and 2010 . However, there was a tendency to decrease in European countries due to the implementation of RCTs' regulation …”

Use of Kampo Diagnosis in Randomized Controlled Trials of Kampo Products in Japan: A Systematic Review

“…As for the limitations of the SR, firstly, there was possible publication bias. Clinical trial registration (the tool to prevent publication bias) was developed in 2005 in Japan [23] . The number of articles about the RCTs in this study is as follows: 1986-89: 11 (2.9%), 1990s: 180 (47.6%), 2000s: 157 (41.5%), 2010-11s:30 (7.9%).…”