Optimizing Collection of Adverse Event Data in Cancer Clinical Trials Supporting Supplemental Indications

PURPOSE: Although much is known about the safety of an anticancer agent at the time of initial marketing approval, sponsors customarily collect comprehensive safety data for studies that support supplemental indications. This adds significant cost and complexity to the study but may not provide usef...

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Detalhes bibliográficos
Main Authors: Kaiser, Lee D., Melemed, Allen S., Preston, Alaknanda J., Chaudri Ross, Hilary A., Niedzwiecki, Donna, Fyfe, Gwendolyn A., Gough, Jacqueline M., Bushnell, William D., Stephens, Cynthia L., Mace, M. Kelsey, Abrams, Jeffrey S., Schilsky, Richard L.
Formato: Artigo
Idioma:Inglês
Publicado em: American Society of Clinical Oncology 2010
Assuntos:
Original Reports
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3018355/
https://ncbi.nlm.nih.gov/pubmed/20921453
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1200/JCO.2010.29.6608
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