𝔖 Bobbio Scriptorium
✦   LIBER   ✦

TESTING FOR TREATMENT DIFFERENCES WITH DROPOUTS PRESENT IN CLINICAL TRIALS – A COMPOSITE APPROACH

✍ Scribed by WEICHUNG JOSEPH SHIH; HUI QUAN

Publisher
John Wiley and Sons
Year
1997
Tongue
English
Weight
395 KB
Volume
16
Category
Article
ISSN
0277-6715

No coin nor oath required. For personal study only.

✦ Synopsis

A major problem in the analysis of clinical trials is missing data from patients who drop out of the study before the predetermined schedule. In this paper we consider the situation where the outcome measure is a continuous variable and the final outcome at the end of the study is the main interest. We argue that the hypothetical complete-data marginal mean averaged over the dropout patterns is not as relevant clinically as the conditional mean of the completers together with the probability of completion or dropping out of the trial. We first take the pattern-mixture modelling approach to factoring the likelihood function, then direct the analysis to the multiple testings of a composite of hypotheses that involves the probability of dropouts and the conditional mean of the completers. We review three types of closed step-down multiple-testing procedures for this application. Data from several clinical trials are used to illustrate the proposed approach.

📜 SIMILAR VOLUMES

Testing for treatment differences with d
Testing for treatment differences with dropouts present in clinical trials – a composite approach by Weichung J. Shih and Hui Quan, Statistics in Medicine, 16, 1225–1239 (1997)
✍ James F. Troendle 📂 Article 📅 1998 🏛 John Wiley and Sons 🌐 English ⚖ 61 KB 👁 2 views

standardized I\* , as described in Oden and Oden et al. The following lines of Dr. Tango's tables are affected: i) I\* normal approximation and I\* chi-square approximation for alpha"0)05 and alpha"0)01 in Tango's tables I and III. ii) I\* critical values for alpha"0)05 and alpha"0)01 in Tango's Tab

Test Equality and Sample Size Calculatio
Test Equality and Sample Size Calculation Based on Risk Difference in a Randomized Clinical Trial with Noncompliance and Missing Outcomes
✍ Kung-Jong Lui; Kuang-Chao Chang 📂 Article 📅 2008 🏛 John Wiley and Sons 🌐 English ⚖ 124 KB 👁 1 views

## Abstract In a randomized clinical trial (RCT), noncompliance with an assigned treatment can occur due to serious side effects, while missing outcomes on patients may happen due to patients' withdrawal or loss to follow up. To avoid the possible loss of power to detect a given risk difference (RD