Workshop Focuses on Ethics in Chinese Clinical Trials

May 16, 2008

Company News Release

Ethics in Chinese Clinical Trials workshop serves as a roadmap for sponsors and researchers.

Beijing, China-May 16, 2008-On May 4, 2008, in Beijing, China, a workshop was held on "Ethics in Chinese Clinical Trials: A Roadmap for Sponsors and Researchers" within the context of the Impact China: Pharmaceutical R&D Global Summit. The workshop was co-organized by the Professor Yali Cong of the Medical Ethics Program at the Peking University Health Science Center, Dr. Haitao Liu, who is the international officer of the Forum for Ethical Review Committees in China (FERCIC), and Francis P. Crawley of the Good Clinical Practice Alliance–Europe (GCPA) and member of the Applied Clinical Trials Editorial Advisory Board.

The workshop presented an overview of the current ethical considerations and procedures for effectively designing, conducting, and registering clinical trials in China. A general overview of the ethical considerations in designing clinical trial protocols and submissions was discussed in a context of the general framework for understanding ethical review and informed consent in China.

A key focus was on the clarifying the working procedures and challenges for ethics committees in China today. Most of the participants were working in the Chinese pharmaceutical and CRO industry, from both national and international companies. The discussion addressed the procedures and issues that arise when developing applications to ethics committees alongside the primary application for clinical trial approval to the State Food & Drug Administration (SFDA). Within this context, comparisons were made to the IRB-ERB review systems in the United States and Canada as well as regarding ethical committee review in Europe.

The SFDA has recently undergone some reorganization within the Ministry of Health (MoH) and the relationship between the ethics committees at the approved trials sites across China appears to be in need of further clarification. Most of the participants agreed that the ethics committees in major cities appeared to be operating both professionally and efficiently. There was some concerned expressed regarding the capacities of ethics committees away from what are currently the major trial centers in China.

Draft guidelines for ethics committees had been prepared by the SFDA in August of 2005, but these need to be further discussed and perhaps revisited within the context of the SFDA being re-housed within the MoH. Not all of the participants were convinced that guidelines, or guidelines alone, would address their major concerns. Some participants considered that more coordination between the ethics committees would go a long way to improving the environment for clinical trials. This included discussion on the possibility of "central ethics committees" within the current framework for clinical trial regulation in China. While this seemed expedient in overcoming the sometime large numbers of committees that need to be consulted, it was not altogether clear if the current regulatory structure would permit this.

A proposal was also made to develop a common application form and a common response form for ethics committees in China. This was seen to be potentially helpful in harmonizing requirements and expectations while also possibly expediting the process of receiving ethical approval for larger multi-center studies.

Last year the Chinese Medical Ethics Association (CMEA) carried out a survey among ethics committees across the country. This survey is currently being analyzed and used as the basis for the planning of developing education programs for members of ethics committees, the design of an evaluation program for ethics committees, and a general overall management approach to ethical review. A second survey to gage the experience of sponsors and researchers in their use of ethics committees in China is being drawn up.

While clinical trials in China have been recently at times dogged by questions regarding their ethical integrity, the participants in this workshop expressed confidence in the ethical review system within China as it is currently developing as well as in the professionalism and competence of the vast majority of ethical review committees active in China.