Formal approaches to safety monitoring of clinical trials in life-threatening conditions

Statistics in Medicine

Volumn 19, Issue 21, 2000, Pages 2899-2917

  Bolland, Kim ^a   Whitehead, John ^a  

^a UNIVERSITY OF READING   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

DOFETILIDE;

ANALYTIC METHOD; ARTICLE; CONGESTIVE HEART FAILURE; DATA ANALYSIS; HEAD INJURY; HEART INFARCTION; HUMAN; MEDICAL DECISION MAKING; MEDICAL ETHICS; OUTCOMES RESEARCH; PATIENT MONITORING; PRACTICE GUIDELINE; SEQUENTIAL ANALYSIS; STROKE;

CEREBROVASCULAR ACCIDENT; CLINICAL TRIALS; CLINICAL TRIALS, PHASE III; CRANIOCEREBRAL TRAUMA; DATA INTERPRETATION, STATISTICAL; HUMANS; MODELS, STATISTICAL; MULTICENTER STUDIES; MYOCARDIAL INFARCTION; NORMAL DISTRIBUTION; PROBABILITY; SAFETY;

EID: 0034669939     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/1097-0258(20001115)19:21<2899::AID-SIM597>3.0.CO;2-O     Document Type: Article

References (24)

1. Interim analysis in clinical trials
2. Practical issues in data monitoring of clinical trials
3. Data and safety monitoring boards
4. Clinical trial data and safety monitoring boards: The search for a constitution
5. On being the statistician on a data and safety monitoring board
6. Sample size calculations for ordered categorical data
7. Sample size review in a head injury trial with ordered categorical responses
8. Discrete sequential boundaries for clinical trials
9. The choice of sequential boundaries based on the concept of power spending
10. A multiple testing procedure for clinical trials
11. A general parametric approach to the meta-analysis of randomized clinical trials
12. Group-sequential analysis incorporating covariate information
13. A unified theory for sequential clinical trials
14. Overrunning and underrunning in sequential clinical trials
15. Dofetilide in patients with congestive heart failure and left ventricular dysfunction
16. Group sequential designs for one-sided and two-sided hypothesis testing with provision for early stopping in favour of the null hypothesis
17. Guidelines for monitoring efficacy and toxicity responses in clinical trials
18. Group-sequential tests for bivariate response: Interim analysis of clinical trials with both efficacy and safety endpoints
19. Sequential designs for monitoring two endpoints in a clinical trial
20. Confidence intervals for secondary parameters following a sequential test
21. Sequential monitoring of clinical trials: The role of information and Brownian motion