We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Adverse event reporting in publications compared with sponsor database for cancer clinical trials.
- Authors
Scharf, Orit; Colevas, A Dimitrios
- Abstract
Prospectively planned collection and analysis of adverse event (AE) data are essential parts of well-conducted clinical trials. The AE data in a trial sponsor's database should be comparable with what is stipulated in the protocol and with the AE data published. We examined whether the published AE data differ from those in the sponsor's database and from the data collection requirements stated in study protocols.
- Publication
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006, Vol 24, Issue 24, p3933
- ISSN
1527-7755
- Publication type
Journal Article
- DOI
10.1200/JCO.2005.05.3959