But experimental gene therapy is being tried, for the most part, in patients who are very sick, usually terminally ill. Some say they did not fully understand the reporting requirements. Improvement is needed. Some patients may not have been properly informed of the risks. That's one of the primary concerns in the death of Gelsinger.
Improvement is needed.
A consensus is developing that serious adverse events from gene therapy studies should be made available while the studies are taking place. This is different from what is required for other clinical studies, in which adverse events are not reported until the study is published or made public. But the government believes that it is in the public's interest to know about gene therapy trials as they are taking place. All indications are that the research community and the companies supporting research agree. As with any new therapy, there are issues of safety.