Sensitivity analysis for missing dichotomous outcome data in multi-visit randomized clinical trial with randomization-based covariance adjustment

2017 ◽  
Vol 27 (3) ◽  
pp. 387-398
Author(s):  
Siying Li ◽  
Gary G. Koch ◽  
John S. Preisser ◽  
Diana Lam ◽  
Matilde Sanchez-Kam
Keyword(s):  
Clinical Trial ◽  
Sensitivity Analysis ◽  
Randomized Clinical Trial ◽  
Outcome Data ◽  
Dichotomous Outcome ◽  
Covariance Adjustment

Time trends with response-adaptive randomization: The inevitability of inefficiency

2022 ◽  
pp. 174077452110657
Author(s):  
Edward L Korn ◽  
Boris Freidlin
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Patient Population ◽  
Time Trends ◽  
Time Trend ◽  
Outcome Data ◽  
Time Block ◽  
Adaptive Randomization ◽  
Analysis Methods ◽  
Randomization Analysis

Response-adaptive randomization, which changes the randomization ratio as a randomized clinical trial progresses, is inefficient as compared to a fixed 1:1 randomization ratio in terms of increased required sample size. It is also known that response-adaptive randomization leads to biased treatment effects if there are time trends in the accruing outcome data, for example, due to changes in the patient population being accrued, evaluation methods, or concomitant treatments. Response-adaptive-randomization analysis methods that account for potential time trends, such as time-block stratification or re-randomization, can eliminate this bias. However, as shown in this Commentary, these analysis methods cause a large additional inefficiency of response-adaptive randomization, regardless of whether a time trend actually exists.

Randomized clinical trial of LigasureTM versus open haemorrhoidectomy

2002 ◽  
Vol 89 (2) ◽  
pp. 154-157 ◽  
Author(s):  
F. F Palazzo ◽  
D. L Francis ◽  
M. A Clifton
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial

Ciprofloxacin is more effective in treating acute pouchitis than metronidazole: A randomized clinical trial

2001 ◽  
Vol 120 (5) ◽  
pp. A453-A453 ◽  
Author(s):  
B SHEN ◽  
J ACHKAR ◽  
B LASHNER ◽  
A ORMSBY ◽  
F REMZI ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial
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