Skip Navigation

JNCI Journal of the National Cancer Institute 2000 92(10):784-786; doi:10.1093/jnci/92.10.784
© 2000 by Oxford University Press
This Article
Right arrow Full Text Freely available
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Request Permissions
Google Scholar
Right arrow Articles by Finn, R.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Finn, R.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

Journal of the National Cancer Institute, Vol. 92, No. 10, 784-786, May 17, 2000
© 2000 Oxford University Press

NEWS

Why Were NIH Adverse Event Reporting Guidelines Misunderstood?

Robert Finn

The death of a patient in a gene therapy trial last October (see News, Jan. 19, p. 98) highlighted widespread confusion among investigators regarding adverse event reporting. In spite of the National Institutes of Health guidelines, many serious adverse events (SAEs) encountered over the last 7 years apparently were not reported to the Recombinant DNA Advisory Committee (RAC) when they occurred. In the months since the death threw a spotlight on clinical trials of gene therapy, the RAC has received a veritable blizzard of reports on SAEs, many of them years old.

In February, Rep. Henry A. Waxman (D-Calif.) claimed that 94% of 691 gene therapy SAEs had not been reported to the RAC in a timely fashion. Retrospective reports are continuing to mount. From January through mid-April 2000, the committee received 780 gene therapy SAE reports, said Amy P. Patterson, M.D., director of NIH’s Office of Biotechnology Activities, . . . [Full Text of this Article]

Staffing Issues

Increasing Reporting


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?