The conscientious judgement of a DSMB - Statistical stopping rules re-examined

European Journal of Clinical Pharmacology

Volumn 64, Issue 1, 2008, Pages 69-72

  Hedenmalm, Karin ^a,b   Melander, Hans ^a   Alvan, Gunnar ^a  

^a MEDICAL PRODUCTS AGENCY   (Sweden)

^b UPPSALA UNIVERSITY   (Sweden)

Author keywords

Clinical trials; Data and Safety Monitoring Boards; Futility criterion; P value flags; Post hoc review; Safety; Statistical stopping rules

Indexed keywords

FIBRINOGEN RECEPTOR ANTAGONIST; LOTRAFIBAN; ORBOFIBAN; ROSIGLITAZONE; SIBRAFIBAN; TIBOLONE; TORCETRAPIB; UNCLASSIFIED DRUG; XERNILOFIBAN;

ANGINA PECTORIS; BREAST CANCER; CARDIOVASCULAR DISEASE; CONGESTIVE HEART FAILURE; DECISION MAKING; DRUG EFFICACY; DRUG FATALITY; DRUG MONITORING; DRUG SAFETY; HEART DEATH; HEART INFARCTION; HUMAN; ISCHEMIC HEART DISEASE; MORBIDITY; MORTALITY; PERIPHERAL VASCULAR DISEASE; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; STATISTICAL ANALYSIS; STROKE;

ANTICHOLESTEREMIC AGENTS; CARDIOVASCULAR DISEASES; CLINICAL TRIALS DATA MONITORING COMMITTEES; DATA INTERPRETATION, STATISTICAL; DECISION MAKING; HUMANS; QUINOLINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT;

EID: 38049053170     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-007-0403-4     Document Type: Review

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