✦ LIBER ✦

AN ALTERNATIVE TO THE USE OF TWO-SIDED TESTS IN CLINICAL TRIALS

✍ Scribed by CHARLES W. DUNNETT; MICHAEL GENT

Publisher: John Wiley and Sons
Year: 1996
Tongue: English
Weight: 700 KB
Volume: 15
Category: Article
ISSN: 0277-6715
DOI: 10.1002/(sici)1097-0258(19960830)15:16<1729::aid-sim334>3.0.co;2-m

No coin nor oath required. For personal study only.

✦ Synopsis

There is a controversy in the literature concerning the use of one-and two-sided tests in clinical trials. Some contend that, when the research question relates to improved efficacy or safety, that is, the expected change is in one direction only, the hypothesis test should reflect this by being one-sided. Others insist on the use of a two-sided test in case a treatment difference in the opposite direction to that expected might turn up. We propose an alternative procedure to the two-sided test which also provides protection against overlooking a negative effect. The proposed procedure tests simultaneously for a positive difference and for equivalence. We illustrate the procedure by applying it to the results of a recent clinical trial.

📜 SIMILAR VOLUMES

The contribution of an independent ethic

The contribution of an independent ethics committee to quality assurance in clinical trials

✍ Angela J. Bowen 📂 Article 📅 1997 🏛 John Wiley and Sons 🌐 English ⚖ 104 KB 👁 2 views

Comparing time to onset of response in a

Comparing time to onset of response in antidepressant clinical trials using the cure model and the Cramer–von Mises test

✍ Roy N. Tamura; Douglas E. Faries; Jin Feng 📂 Article 📅 2000 🏛 John Wiley and Sons 🌐 English ⚖ 167 KB 👁 2 views

Using covariates to reduce uncertainty i

Using covariates to reduce uncertainty in the economic evaluation of clinical trial data

✍ F. J. Vázquez-Polo; M. A. Negrín Hernández; B. González López-Valcárcel 📂 Article 📅 2005 🏛 John Wiley and Sons 🌐 English ⚖ 202 KB 👁 1 views

## Abstract As part of their practice, policymakers have to make economic evaluations using clinical trial data. Recent interest has been expressed in determining how cost‐effectiveness analysis can be undertaken in a regression framework. In this respect, published research basically provides a ge

The use of two linked scanning modes in

The use of two linked scanning modes in alternation to analyse metastable peaks

✍ Michael J. Lacey; Colin G. Macdonald 📂 Article 📅 1980 🏛 John Wiley and Sons 🌐 English ⚖ 425 KB

Using the bootstrap for estimation in gr

Using the bootstrap for estimation in group sequential designs: an application to a clinical trial for nasopharyngeal cancer

✍ Michael LeBlanc; John Crowley 📂 Article 📅 1999 🏛 John Wiley and Sons 🌐 English ⚖ 159 KB 👁 2 views

We investigate a resampling method for bias correction in group sequential designs with censored survival data using logrank testing. The method draws nested bootstrap samples of di!erent sizes from the observed data in order to mimic the large sample independent increment property of statistics res

Voting with their feet (VWF) endpoint: A

Voting with their feet (VWF) endpoint: A meta-analysis of an alternative endpoint in clinical trials, using 5-ASA induction studies in ulcerative colitis

✍ Sujal C. Rangwalla; Akbar K. Waljee; Peter D.R. Higgins 📂 Article 📅 2009 🏛 John Wiley and Sons 🌐 English ⚖ 149 KB

## Background: Strict clinical remission endpoints in ulcerative colitis (uc) trials produce low remission rates and do not reflect the good outcomes of uc therapy. we proposed the use of the vwf (voting with their feet) endpoint, the percentage of subjects leaving a randomized controlled trial (rc