000			01611nam a2200349 a 4500
001			vtls000046971
003			KUKTEM
005			20251117150230.0
008			100705t2009 flua f b 001 0 eng d
020			_a9781420070378 (hardcover : alk. paper)
020			_a1420070371 (hardcover : alk. paper)
039		9	_a201107132355 _bVLOAD _c201011021203 _dfauzi _y201007051638 _zshikin
040			_aUMP
090			_aRM301.27 .H47 2009
100	1		_aHerson, Jay
245	1	0	_aData and safety monitoring committees in clinical trials / _cJay Herson
260			_aBoca Raton, FL : _bChapman & Hall/CRC, _cc2009
300			_axviii, 173 p. : _bill. ; _c25 cm.
490	1		_aChapman & Hall/CRC biostatistics series ; _v30
504			_aIncludes bibliographical references (p. 155-166) and index
505	0		_aIntroduction -- Organization of a safety monitoring program for a confirmatory trial -- Meetings -- Clinical issues -- Statistical issues -- Bias and pitfalls -- Data monitoring committee decisions -- Emerging issues
650		0	_aDrugs _xTesting _xEvaluation
650		0	_aDrugs _xTesting _xStatistical methods _xEvaluation
650	1	2	_aClinical Trials Data Monitoring Committees _xorganization & administration
650	1	2	_aClinical Trials as Topic _xstandards
650	2	2	_aData Collection
650	2	2	_aDrug Industry _xstandards
650	2	2	_aResearch Design
650	2	2	_aSafety Management
830		0	_aChapman & Hall/CRC biostatistics series ; _v30
999			_aVIRTUA40 _c54143 _d54149
999			_aVTLSSORT0080*0200*0201*0400*0900*1000*2450*2600*3000*4900*5040*5050*6500*6501*6502*6503*6504*6505*6506*6507*8300*9991