SFDA Drafts Clinical Trial Ethical Review Guidelines

SHANGHAI - China's State FDA has opened a public consultation period for draft guidelines on ethical reviews for clinical trials.

The guidelines cover the establishment and responsibilities of ethics committees and the review system for multi-hospital clinical trials.

Under the new guidelines, informed consent forms for clinical trials must clarify the nature of the trials and their research purpose, the possibility of random assignment for treatment arms, potential invasive procedures and possible benefits and risks to participants.

In the event of research-related injuries, subjects may be compensated, and they are free to withdraw from the trials at any time without penalties.

"The guidelines aim to protect human subjects' lawful rights and interests," Shi Luwen, director of the Beijing-based International Research Center for Medicinal Administration, told PharmAsia News.

"Subjects must be fully informed and have all rights to choose," said Shi, "especially vulnerable groups such as children and mentally disabled persons who are unable to understand informed consent forms."

She said there must be a legitimate reason for including vulnerable patient populations in a clinical trial, and that for trials involving children and mentally disabled persons, ethics committees need to confirm that the study is dependent upon their participation. For example, ethics committees will need to confirm that the disease studied specifically targets these vulnerable groups, as well as obtain approval from trial participants' legal guardians before starting clinical trials.

Better Coordination For Multi-center Trials

The draft also issues guidelines about operating an ethical review system for multi-center clinical trials to examine the consistency and timeliness of ethics reviews. The guidelines stipulate that ethics committees from every center should establish a collaborative program to ensure an overarching review.

For multi-center clinical trials, the host ethics committee is responsible for the timely review of serious adverse events and to inform ethics committees of other centers about research findings.

"In China, before entering clinical trials, clinical trial applicants must obtain approval from ethics committees," said Shi. "But China's current regulations on the ethical review of clinical trials have not been clear about the guiding principles, and every region has varying levels of ethical reviews."

China's current informed consent process is not comprehensive enough, according to Shi.

To improve China's ethics review system, the new guidelines give ethics committees the power to approve clinical trials, the power to track reviews of the approved clinical trials and the power to terminate or suspend clinical studies that have been approved.

Clinical trials in China can only be conducted at SFDA-accredited sites. According to SFDA, as of August 2009, there were 335 clinical sites including hospitals and universities that were approved by SFDA to conduct clinical trials. Each site is required to have an ethics committee.

The dramatic growth in clinical trials for new drugs being staged in developing countries has generated demand for new national regulations and codes of ethical conduct of clinical research.

"The focus for the future of ethics committees in China is on more training, continued adoption of standard operating procedures and more harmonization," Shi said.

- Ying Huang ([email protected])