Abstract
Two similarly designed, placebo-controlled clinical trials are fully accrued and following patients for safety and outcome data. One trial is stopped at a planned interim analysis by its data safety and monitoring board (DSMB) due to a statistically significant treatment benefit. The statisticians and DSMB of the other trial are informed of these results. What are the responsibilities of the statistical center? How should the DSMB deal with the situation if the data do not support the stopped trial? What should the patients be told concerning the results of the two trials when one trial continues and the other is stopped? This DSMB case study reports on such a situation for two randomized clinical trials of oral ganciclovir for the prevention of cytomegalovirus disease in HIV/AIDS patients.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 85-91 |
| Number of pages | 7 |
| Journal | Controlled Clinical Trials |
| Volume | 24 |
| Issue number | 1 |
| DOIs | |
| State | Published - Feb 2003 |
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Keywords
- Clinical trial
- Data and Safety Monitoring Board (DSMB)
- Interim monitoring
ASJC Scopus subject areas
- Pharmacology
Cite this
DSMB case study : Decision making when a similar clinical trial is stopped early. / Hillman, David W.; Louis, Thomas.
In: Controlled Clinical Trials, Vol. 24, No. 1, 02.2003, p. 85-91.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - DSMB case study
T2 - Decision making when a similar clinical trial is stopped early
AU - Hillman, David W.
AU - Louis, Thomas
PY - 2003/2
Y1 - 2003/2
N2 - Two similarly designed, placebo-controlled clinical trials are fully accrued and following patients for safety and outcome data. One trial is stopped at a planned interim analysis by its data safety and monitoring board (DSMB) due to a statistically significant treatment benefit. The statisticians and DSMB of the other trial are informed of these results. What are the responsibilities of the statistical center? How should the DSMB deal with the situation if the data do not support the stopped trial? What should the patients be told concerning the results of the two trials when one trial continues and the other is stopped? This DSMB case study reports on such a situation for two randomized clinical trials of oral ganciclovir for the prevention of cytomegalovirus disease in HIV/AIDS patients.
AB - Two similarly designed, placebo-controlled clinical trials are fully accrued and following patients for safety and outcome data. One trial is stopped at a planned interim analysis by its data safety and monitoring board (DSMB) due to a statistically significant treatment benefit. The statisticians and DSMB of the other trial are informed of these results. What are the responsibilities of the statistical center? How should the DSMB deal with the situation if the data do not support the stopped trial? What should the patients be told concerning the results of the two trials when one trial continues and the other is stopped? This DSMB case study reports on such a situation for two randomized clinical trials of oral ganciclovir for the prevention of cytomegalovirus disease in HIV/AIDS patients.
KW - Clinical trial
KW - Data and Safety Monitoring Board (DSMB)
KW - Interim monitoring
UR - http://www.scopus.com/inward/record.url?scp=0037307422&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0037307422&partnerID=8YFLogxK
U2 - 10.1016/S0197-2456(02)00274-X
DO - 10.1016/S0197-2456(02)00274-X
M3 - Article
C2 - 12559646
AN - SCOPUS:0037307422
VL - 24
SP - 85
EP - 91
JO - Controlled Clinical Trials
JF - Controlled Clinical Trials
SN - 0197-2456
IS - 1
ER -