Expanded access programmes: patient interests versus clinical trial integrity

The first-line phase 3 study with tremelimumab did not show an improvement in its primary endpoint, overall survival, and the drug was never licensed.2,7 At least a third of patients randomly assigned to the control group who were alive at the end of the study or censored at any point had received i...

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Veröffentlicht in:	The lancet oncology 2015, Vol.16 (1), p.15-17
Hauptverfasser:	Lorigan, Paul, Ascierto, Paolo A, Dummer, Reinhard, Eggermont, Alexander M, Flaherty, Keith T, Garbe, Claus, Gogas, Helen, Hauschild, Axel, Kefford, Richard F, Kirkwood, John M, Larkin, James, Long, Georgina V, Maio, Michele, McArthur, Grant A, Ribas, Antoni, Robert, Caroline, Schadendorf, Dirk, Sondak, Vernon K, Wolchok, Jedd D, Hudson, Andrew M
Format:	Artikel
Sprache:	eng
Schlagworte:	Clinical Trials as Topic - ethics Compassionate Use Trials - ethics Health Services Accessibility - ethics Hematology, Oncology and Palliative Medicine Humans Immunotherapy Medical research Patient Rights - ethics Patient Safety Pharmaceutical industry Risk Assessment Risk Factors Studies Treatment Outcome
Online-Zugang:	Volltext
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