Bridging studies are clinical trials to compare the safety and effects of IMPs in different ethnic groups. Bridging studies can help sponsors get earlier approval for their IMPs in Japan.
Since 1993, we’ve done many studies in healthy Caucasians for Japanese companies, large and small. Since 2002, we’ve also done bridging studies in healthy Japanese subjects, to compare results with those from Caucasians. We’ve even done three studies to compare Caucasians, Japanese, Koreans and Chinese.
About 65,000 Japanese people live in the UK. That’s enough to enable us to do bridging studies in a timely manner. The largest Japanese community in London is close to HMR.
Our Japanese-speaking staff have over 10 years’ experience of bridging studies and our dedicated team of 17 bilingual Japanese nurses and support staff have substantial experience of bridging studies. They recruit suitable subjects, translate trial documents and help do the studies. We’ve done over 30 bridging studies trials including:
- bioequivalence studies of new products not yet marketed in Japan;
- studies that can’t be done in Japan, such as studies of opioids;
- ‘add-on’ cohorts of Japanese subjects in large, complex, first-in-man single- and repeat-dose trials in Caucasians;
- studies of biological products, including monoclonal antibodies and siRNA;
- studies in Japanese poor and extensive metabolisers; and
- PET studies in Japanese subjects.
Those studies have helped sponsors satisfy Japanese bridging studies regulatory authority requirements.