- ►annals.org SN Goodman - Annals of Internal Medicine, 2007 - Am Coll Physicians This commentary reviews the argument that clinical trials with data monitoring committees that
use statistical stopping guidelines should generally not be stopped early for large observed efficacy
differences because efficacy estimates may be exaggerated and there is minimal ... Cited by 20 - Related articles - BL Direct - All 3 versions
XF Fan, DL DeMets, KK Lan - Journal of biopharmaceutical statistics, 2004 - ncbi.nlm.nih.gov Repeated significance testing in a sequential experiment not only increases the overall type
I error rate of the false positive conclusion but also causes biases in estimating the unknown
parameter. In general, the test statistics in a sequential trial can be properly approximated ... Cited by 8 - Related articles - BL Direct - All 3 versions
B Freidlin, EL Korn - Clinical Trials, 2009 - ctj.sagepub.com Background It has been suggested in the literature that the well-known bias of treatment-effect
estimators due to the possibility of early stopping for positive results is a major concern with interim
monitoring. Purpose To discuss approaches one might use to compare the inflation of the ... Cited by 4 - Related articles - All 2 versions
- ►ceb-institute.org [PDF] D Bassler, I Ferreira-Gonzalez, M Briel, DJ Cook, … - Journal of Clinical …, 2007 - Elsevier We searched the Cochrane Library and MEDLINE and evaluated systematic reviews that include
at least one tRCT. We documented approaches that authors used to address potential overestimates
of treatment effect introduced by including tRCTs. We assessed the impact of tRCTs in ... Cited by 18 - Related articles - All 10 versions
- ►angrylapdog.com PS Mueller, VM Montori, D Bassler, … - Annals of Internal …, 2007 - annals.org.p.angrylapdog.com Stopping randomized trials early because of an apparent benefit is becoming more
common. To protect and promote the interests of trial participants, investigators may feel obligated
to stop a trial early because of the apparent benefit of a study treatment (compared with ... Cited by 34 - Related articles - BL Direct - All 3 versions
SN Goodman - Journal of Clinical Epidemiology, 2008 - Elsevier This comment is made based on simulations where 100% of trials used in a meta-analysis use
a stopping rule (the same rule) that would maximally amplify any effect of such trials. What they
mean by “approximate unbiasedness” can be shown in this example. Let us assume a set ... Cited by 5 - Related articles - All 6 versions
J Wittes, E Barrett-Connor, E Braunwald, M Chesney, … - Clinical Trials, 2007 - ctj.sagepub.com In postmenopausal women, the randomized clinical trials of the Women's Health Initiative
(WHI) studied the risks and benefits of estrogen therapy, a low-fat diet, and supplementation
with calcium and vitamin D [1] as interventions for reducing the inci- dence of heart ... Cited by 9 - Related articles - BL Direct - All 4 versions
[CITATION] On behalf of the JUPITER Trial Study Group. Reduction in C-reactive protein and …
RA Wilcox, B Djulbegovic, GH Guyatt, VM … - Journal of Clinical …, 2008 - jcojournal.org Investigators conducting randomized controlled trials (RCTs) who find a large treatment effect
before the planned completion of the study may terminate the study early. A systematic review
of RCTs that were stopped early for benefit recently concluded that many of these trials ... Cited by 13 - Related articles - All 4 versions
SI George, MR Green - Data Monitoring in Clinical Trials. New York, NY, …, 2006 - Springer The role of adjuvant chemotherapy in the treatment of breast cancer has been the subject of
intense research activity in recent years.It is now gener- ally accepted that some types of adjuvant
therapy have a positive effect on disease-free and overall survival,but the effect size ... Cited by 2 - Related articles - All 2 versions
