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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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.
Format: Artigo
Jezik:Inglês
Izdano: American Society of Clinical Oncology 2010
Teme:
Original Reports
Online dostop: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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