CRCs 'growth opportunity' in Japan

According to Takatoshi Sato, chairman of Hyclips Japan, CRCs are critically needed to cope with Japan's growing clinical trials industry, which is currently being heavily promoted by the government, attendees heard at last week's Drug Information Association (DIA) conference in Vienna. CRCs work under the direction of clinical research associates (CRAs) and principle investigators with responsibilities including arranging a study site; recruiting, screening and enrolling participants; arranging follow-ups; maintaining and dispensing drugs and other supplies; completing and ensuring the accuracy of case report forms (CRFs) and regulatory documents; and ensuring the adherence to good clinical practice (GCP) guidelines. "700 CRCs are currently hired by Japansese hospitals but 5000 more are needed to help in the clinics which are all very busy at the moment,"​ said Noriaki Muraro, representative director of Schwarz Pharma Japan who was presenting Sato's presentation in his absence. CRCs are being brought into the fray to assist and help manage clinical trial investigators who are extremely short of time and need help - CRAs are unable to do this as their role is to act as a "referee" during the trial process. The Japanese clinical trial environment has typically been burdened by red tape (sometimes up to 150 essential documents being required as part of good laboratory practice (GLP) paperwork), slow patient recruitment and trial duration (often 2-2.5 times longer than in the US and Europe). Serious efforts are now being made within Japan to achieve a cost and speed that is comparable to the US and Europe and attract a comparable number of global clinical studies to other Asian countries. ​​As a result, SMOs (including hospitals), who provide CRCs among other related services, have been springing up all over Japan - there are now 200 and the Japanese Association of SMOs (JASMO) was established in 2003 with 58 members. ​ ​In addition, the types of trials currently being run in Japan are usually confirmatory or post-marketing studies because of Japan's cumbersome clinical trial regulatory climate, coupled with the inter-ethnic differences in dose-response between Japanese and Caucasian populations, and these types of trials are typically much less interesting for investigators, said Sato. "Because of this CRCs are also becoming important in helping to stimulate investigators during the trial process." ​ Although the use of SMOs adds to the cost of the trial, sponsors are now taking measures to minimise this, usually by negotiating performance-based forms of payment such as milestones. "This is tough for the SMOs but they are able to survive this way because clinical research in Asia is booming,"​ said Sato. "Many are adapting by basing their offices in cheaper neighbouring locations such as China." ​