PMID: 8595799Aug 1, 1995Paper

How reliable are clinical trials? The importance of the criteria for early termination

European Heart Journal
P J Schwartz

Abstract

The early termination of clinical trials, for either benefit or harm, often generates undue enthusiasm or alarm. The enhanced publicity attending early termination of a trial promotes inappropriate interpretations that are aided by the inherent difficulty of prompt and comprehensive data review. Furthermore, the process of monitoring the accumulating outcome data for early evidence of treatment benefit or harm is fraught with many statistical and methodological difficulties. This article is based on a report from a Task Force convened by the Working Group on Arrhythmias of the European Society of Cardiology. It reviews, as examples to illustrate the importance of suitable trial design and of proper stopping rules, a series of trials terminated appropriately or inappropriately for benefit or harm; it analyses the general design issues and it reviews the main issues in interim analysis with special reference to main strategies for reducing the rate of false-positive claims that could result from early trial termination.

Citations

Aug 8, 2002·Therapeutic Apheresis : Official Journal of the International Society for Apheresis and the Japanese Society for Apheresis·Sebastian Schulte-EistrupYukihiko Nosé

❮ Previous
Next ❯

Related Concepts

Related Feeds

Cardiology Journals

Discover the latest cardiology research in this collection of the top cardiology journals.

Arrhythmia

Arrhythmias are abnormalities in heart rhythms, which can be either too fast or too slow. They can result from abnormalities of the initiation of an impulse or impulse conduction or a combination of both. Here is the latest research on arrhythmias.

Atrial Fibrillation

Atrial fibrillation is a common arrhythmia that is associated with substantial morbidity and mortality, particularly due to stroke and thromboembolism. Here is the latest research.