Guideline on Missing Data in Confirmatory Clinical Trials

Guideline on the investigation of subgroups in confirmatory clinical trials

Response Profiles for Longitudinal Clinical Trial Data with Subject Dropout under Regulatory Considerations

Treatment effects are often evaluated by comparing change over time in outcome measures. However, valid analyses of longitudinal data can be problematic, particularly when subjects dropout prior to completing the trial for reasons related to the outcome. In choosing the primary analysis for confirmatory clinical trials, regulatory agencies have for decades favored the last observation carried f...

Assessing response profiles from incomplete longitudinal clinical trial data under regulatory considerations.

Treatment effects are often evaluated by comparing change over time in outcome measures. However, valid analyses of longitudinal data can be problematic, particularly when some data are missing for reasons related to the outcome. In choosing the primary analysis for confirmatory clinical trials, regulatory agencies have for decades favored the last observation carried forward (LOCF) approach fo...

تحلیل به قصد درمان در مطالعات کارآزمایی بالینی: یک مطالعه مروری

Background & Aim: Randomized controlled trials often suffer from two major problems, i.e., noncompliance and missing outcomes. One potential solution to this problem is using the intention-to-treat (ITT) analysis approach. Therefore, the aim of this study was to review the concept of ITT and the most important issues related to it in practice since RCT researchers utilize it as a guide in order...

A Critical Review of Kohlberg’s Theory of Moral Judgment and a Guideline on its Developmental Stages

A Critical Review of Kohlberg’s Theory of Moral Judgment and a Guideline on its Developmental Stages   A.R. Assaareh, Ph.D. * A. Mahdizaadeh Tehraani** A.R. Amini Zarrin*** S. Azimi****   Developmental theories describe and explain stages in which different aspects of human psyche develop. Among such theories is Kohlberg’s theory of moral judgment wherein a complex ...