EDITORIAL: Rules for clinical trials

Clinical trials are a form of experimentation on humans. Researchers conducting clinical trials to evaluate the efficacy and safety of new drugs and medical treatments are required to provide people participating in the trials with an adequate explanation about the risks involved.

This is crucial to ensuring that individuals make informed and independent decisions about whether or not they take part in these studies and experimental treatments.

This is one of the basic principles of human subject medical research established by the Declaration of Helsinki, an ethical code developed by the World Medical Association. The rules were created following the bitter lessons learned from the evil human experiments conducted by Nazi Germany.

Revelations about a clinical test of a peptide-based cancer vaccine developed by the University of Tokyo's Institute of Medical Science have raised concerns about the safety of its subjects and the extent to which their human rights were respected.

One of the enrolled patients who received the vaccine at the institute's hospital suffered gastrointestinal hemorrhage, or bleeding in the digestive tract. The institute reported the bleeding as "a serious adverse event" to the hospital, but failed to alert any of the other university hospitals to which it had supplied similar peptides.

The institute's hospital subsequently revised the clinical test plan to exclude patients considered to be at risk of such bleeding, and added a description of the change to the written explanation provided to potential participants before obtaining their consent.

At other university hospitals which were not informed of the situation, the subjects of similar trials were not given this important piece of information when making decisions about voluntary participation in the trials.

The University of Tokyo's institute collected information about adverse events from the university hospitals to which it had supplied peptides. It claims it was not obliged to report the bleeding event to them.

From the viewpoint of protecting the safety and rights of trial subjects, however, it is clear that the lab should have provided this important information to the other universities. Health, Labor and Welfare Minister Rituso Hosokawa has promised to launch an investigation. That inquiry should be conducted as a matter of urgency and should find out whether the participants in the institute's trial were actually told about the case of gastrointestinal bleeding.

In Japan, clinical trials to gather data needed to obtain government approval for the production and sale of new drugs are rigorously regulated by the Pharmaceutical Affairs Law and other legislation.

In contrast, researcher-led clinical tests like the peptide-based cancer vaccine trial are regulated only by health ministry administrative guidelines. These guidelines are not legally binding and do not stipulate any punishment for violations.

In order to guarantee the safety of clinical trial participants, this double standard should be eliminated. A system subjecting such research-oriented clinical trials to scrutiny by an independent body such as a government agency should be established.

Currently, data collected through general clinical tests cannot be used to help certify new drugs. Fresh clinical trials under the more heavily regulated system for obtaining government approval for the production and sale of drugs are required. This system imposes a heavy burden on researchers and can put Japanese pharmaceutical makers at a disadvantage against their Western rivals when competing to develop new drugs.

As one of the key components of its new growth strategy, the government has pledged to make efforts to promote the development of innovative pharmaceutical products and medical treatments based on university research.

As part of these efforts, the government should enact legislation to establish a unified system to evaluate clinical research and allow data collected from clinical trials, including those not specifically aimed at getting a particular medicine approved, to be used to get government certification.

Eliminating the double standard for clinical trials would help ensure the safety of participants in clinical trials, and lead to more efficient use of research results.

--The Asahi Shimbun, Oct. 16