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For customers outside of Japan

The SMO plays a critical role in Japan's clinical trials landscape

Oct. 3, 2016

Japan’s clinical environment differs in many respects from other countries. Even within Asia, there are important differences between Japan and its closest neighbors Korea and Taiwan, with which it is often grouped. The SMO, or Site Management Organization, plays a crucial role, therefore, in mapping a route through this varied and extensive landscape.

Three major factors shape Japan’s clinical environment. The first is the predominance of testing in small sites, which reflects the large part played by specialized clinics and small hospitals in delivering healthcare in Japan. With the exception of cancer, orphan or CNS, which is generally undertaken in large facilities and teaching hospitals, many therapeutic areas that are the focus of current development are treated in smaller hospital and clinics.

A study in 2011 dramatically outlines the importance of small-site testing in Japan, largely because of the scale involved. It listed 803 study sites in Japan, compared to 108 on Korea and 114 in Taiwan. Significantly, sites of fewer than 20 beds accounted for the largest site size-category (312 sites) in Japan. This large presence of smaller units, however, presents a logistical and numerical challenge that is not present in Taiwan or Korea, where no clinical site is fewer than 200 beds. Also in 2011, a total of 5,766 patients were recruited in Japan, an accomplishment made possible by the SMO’s outreach to these smaller sites. Ensuring that Japan’s small sites do not fall ‘off the radar’ is an important part of the work of the SMO.

The second factor is the relatively smaller directional role government plays in the promotion of clinical trials in Japan. One aspect of this approach is that Japan does not require clinical trials to be conducted in teaching hospitals or pre-accredited sites. Trials can be conducted at smaller hospitals and clinics on a case-by-case basis. The advantage is that access to a trial is made widely available, regardless of size and location. The SMO provides the facility with the required CRC facilities and expertise. However, since there is no need for a hospital to maintain a permanent CRC facility, some large hospitals and teaching hospitals—as well as the smaller sites—may not have them. SMOs therefore play a valuable role in bringing these excellent hospitals into the trial. They also help potential developers, particularly those from overseas, ‘find the right front door’ in selecting a partner for a clinical trial.

The third factor is that the SMO plays a leadership role in preparing documentation, as well as coordinating between patients and hospitals. Small clinics are where many clinical trials take place, and as such the SMO is in possession of extensive information of vital importance to pharmaceutical companies.

Overall, however, Japan is a highly attractive market for clinical trials. By understanding the importance of, as well as the advantages of working with, SMOs, pharmaceutical companies can leverage their unique position in the Japan market for creating successful results.

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