Monday, August 12, 2013

Japan's credibility questioned in clinical trials

Today in the Wall Street Journal, new revelations of Japan altering statistical analysis prompts author Kana Inagaki to ask whether or not it's time for Japan to elevate their clinical trial standards so that they are closer to those of the United States and the European Union. It was found that data in the studies for Diovan in two Japanese universities had been modified. Iwao Kuwajima, chair of the Japanese Organization of Clinical Research Evaluation and Review now believes that the credibility of Japanese clinical research has been compromised.

According to Novartis, at the time of the clinical trials on Diovan in 2001, there were no guidelines in Japan that clearly regulated conflict of interest in clinical research. They were later set up by the education ministry in 2006. Due to the lack of regulations, tampering could have been more common than if the studies were conducted in a country with more strict regulations. In the United States, it is required that statistical analysis be done by a third party and Inagaki points to the shortage in Japan of experts in statistical analysis.

What is Japan doing to correct these errors?
Japan’s health minister recently said a 12-member panel probing the studies — which includes Mr. Kuwajima–will consider revising ethical guidelines on clinical research. Separately, the Japanese government also plans to require universities and hospitals to retain their research data over the longer term so figures can be traced back if research results are later in doubt. Now, there are no guidelines on how long Japanese medical researchers must keep data.

How can companies overcome these errors in their sites in the future?  This September in Shanghai, Yi Yan, Director of Compliance Oversight at Pfizer will be joining Partnerships in Clinical Trials Asia to present Using a Cooperative Risk-Based Approach for Ensuring Quality and Compliance within a Strategic Partnership to look at how to control quality oversite in a a partnership with your sites in Asia.  For more information on this session and the rest of the program, download the agenda.  If you'd like to join us in Shanghai September 4-6, as a reader of this blog when you register to join us and mention code XP1875BLOG, you'll save 15% off the standard rate!  Have any questions or want to get involved?  Feel free to reach out to Jennifer Pereira.

Do you think that Japan needs to elevate their clinical trial standards to those of the United States and the European Union?  Who would this affect their standing in the clinical trials world?

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