Incorporating data received after a sequential trial has stopped into the final analysis: implementation and comparison of methods.
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.
Department of Statistics, University of Colombo, Sri Lanka.
Marina Roshini
MR
Sooriyarachchi
John
J
Whitehead
Tatsuru
T
Matsushita
Kim
K
Bolland
Anne
A
Whitehead
D001699:Biometry; D002121:Calcium Channel Blockers / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D007172:Erectile Dysfunction / Q000188:drug therapy; D006801:Humans; D017275:Isradipine / Q000627:therapeutic use; D008297:Male; D015233:Models, Statistical; D010879:Piperazines / Q000627:therapeutic use; D011687:Purines; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D000068677:Sildenafil Citrate; D020521:Stroke / Q000188:drug therapy; D013450:Sulfones; D013997:Time Factors; D014665:Vasodilator Agents / Q000627:therapeutic use
D002121:Calcium Channel Blockers; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D014665:Vasodilator Agents; D000068677:Sildenafil Citrate; D017275:Isradipine