40 - Efforts to Streamline the IRB Reviews of Multicenter Clinical Trials in Japan

Background:  The introduction of central reviews in Japan is now struggling. The Japanese GCP regulation amendment in 2008 allows the investigational institutions to select IRBs and improved the efficiency by external review process, but it has stagnated for the last 10 years. Most large institutions, mainly AMCs, had very little experience with external IRBs.

Program

Description:  To introduce IRB environment in Japan, the R&D Head Club survey result was utilized. R&D Head Club is a meeting body consisting of the heads of clinical development of R&D-based pharmaceutical companies. Workgroup 3 was formed to promote the utilization of central IRBs and began its activities in 2018 (R&DHC WG3). Author is participating in R&DHC WG3 as one of the advisors. The workgroup analyzed the institutional environment and developed forceful awareness-raising activities at clinical trial-related conferences held in Japan. Through our speeches and other activities, we stressed the importance of central review, improving the efficiency of clinical trials, and increasing the competitiveness of facilities.

Program

Assessment:  The number of IRBs in Japan was estimated to be close to 4,000 in 2007, but as of January 2023, the number was 1,292. (Legal registration began in October 2008.) In the 2009-2011 survey, 30% of implementing institutions were using external IRBs, compared to 1% of AMCs.
In a survey of 185 facilities in August 2023, 93.2% had an IRB and 49.3% had procedures that allowed for external IRB use. The frequency of meetings was once a month for 92.8%, and 98.6% had no intention of increasing the frequency.
A symposium to discuss the central IRB was held at the national conference held in September 2023 with CRC and clinical trial office staff as the main target audience. In a survey of 101 participants in this symposium, 95% agreed that a central IRB is needed.
Since the data tabulation for each trial cannot be collected until the trial is completed, the results of the educational activities will not be known until 4-5 years later.

Limitations: Japanese regulatory agency believes the current rule is enough to promote central reviews because all institutions can already choose any IRB. Sponsors do not want to exert coercive power to designate IRBs. Even though the understanding of site staffs, many AMCs have not reached their behavioral change for central reviews. Now R&DHC WG3 is asking the agency to issue the guidance for central reviews.

Discussion:  Japan's IRB system follows the U.S. in many ways. By listening to the single IRB situation and the process of overcoming the situation at university hospitals and other IRBs in the U.S., we would like to have “KAIZEN” in our system, which enables us to avoid multiple reviews while maintaining a strong philosophy of human research subject protections and winning the trust of the investigational institutions and their staffs.