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.
Safety needs to be closely monitored and regularly reevaluated.
Increased attention is being paid to this issue. Both the NIH and the FDA are establishing new rules to assure that these needed improvements will be made. Health officials in Washington believe that more oversight is needed of gene therapy studies to assure that patients in studies are adequately protected. Even President Clinton has spoken on this matter. So, if you are considering participating in a gene therapy study, be sure that you fit into the medical criteria of the study.