Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
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TY - JOUR
T1 - Incorporating data received after a sequential trial has stopped into the final analysis: implementation and comparison of methods.
AU - Whitehead, John
AU - Bollard, Kim
AU - Matsushita, Tatsuru
AU - Sooriyarachchi, Marina Roshini
AU - Whitehead, Anne
N1 - RAE_import_type : Journal article RAE_uoa_type : Statistics and Operational Research
PY - 2003/9
Y1 - 2003/9
N2 - In a sequential clinical trial, accrual of data on patients often continues after the stopping criterion for the study has been met. This is termed "overrunning." Overrunning occurs mainly when the primary response from each patient is measured after some extended observation period. The objective of this article is to compare two methods of allowing for overrunning. In particular, simulation studies are reported that assess the two procedures in terms of how well they maintain the intended type I error rate. The effect on power resulting from the incorporation of "overrunning data" using the two procedures is evaluated.
AB - In a sequential clinical trial, accrual of data on patients often continues after the stopping criterion for the study has been met. This is termed "overrunning." Overrunning occurs mainly when the primary response from each patient is measured after some extended observation period. The objective of this article is to compare two methods of allowing for overrunning. In particular, simulation studies are reported that assess the two procedures in terms of how well they maintain the intended type I error rate. The effect on power resulting from the incorporation of "overrunning data" using the two procedures is evaluated.
U2 - 10.1111/1541-0420.00081
DO - 10.1111/1541-0420.00081
M3 - Journal article
VL - 59
SP - 701
EP - 709
JO - Biometrics
JF - Biometrics
SN - 1541-0420
IS - 3
ER -