Challenging Issues in Clinical Trial Design Part 4 of a 4-Part Series on Statistics for Clinical Trials

[摘要] As a sequel to last week's paper on the fundamentals of clinical trial design, this paper tackles related controversial issues: noninferiority trials, the value of factorial designs, the importance and challenges of strategy trials, Data Monitoring Committees (including when to stop a trial early), and the role of adaptive designs. All topics are illustrated by relevant examples from cardiology trials. (C) 2015 by the American College of Cardiology Foundation.

[发布日期] 2015-12-29

[关键词] adaptive designs;Data Monitoring Committees;factorial designs;noninferiority trials;randomized controlled trials as topic;statistical stopping guidelines;strategy trials