Accelerated Approval of Cancer Drugs: Improved Access to Therapeutic Breakthroughs or Early Release of Unsafe and Ineffective Drugs?

Accelerated approval (AA) was initiated by the US Food and Drug Administration (FDA) to shorten development times of drugs for serious medical illnesses. Sponsors must confirm efficacy in postapproval trials. Confronted with several drugs that received AA on the basis of phase II trials and for whic...

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Veröffentlicht in:	Journal of clinical oncology 2009-09, Vol.27 (26), p.4398-4405
Hauptverfasser:	RICHEY, Elizabeth A, LYONS, E. Alison, CARSON, Kenneth R, EDWARDS, Beatrice J, GILCHRIST-SCOTT, Douglas, KUZEL, Timothy M, RAISCH, Dennis W, TALLMAN, Martin S, WEST, Dennis P, HIRSCHFELD, Steven, GRILLO-LOPEZ, Antonio J, BENNETT, Charles L, NEBEKER, Jonathan R, SHANKARAN, Veena, MCKOY, June M, THANH HA LUU, NONZEE, Narissa, TRIFILIO, Steven, SARTOR, Oliver, BENSON, Al B
Format:	Artikel
Sprache:	eng
Schlagworte:	Antineoplastic Agents - therapeutic use Biological and medical sciences Clinical Trials, Phase III as Topic Drug Approval - legislation & jurisprudence Drug Approval - methods Humans Kaplan-Meier Estimate Medical sciences Neoplasms - drug therapy Original Reports Orphan Drug Production - legislation & jurisprudence Orphan Drug Production - methods Orphan Drug Production - statistics & numerical data Proportional Hazards Models Time Factors Tumors United States United States Food and Drug Administration
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