Modelling and simulating early stopping of RCTs: a case study of early stop due to harm

Abstract
Despite efforts from regulatory agencies (e.g. NIH, FDA), recent systematic reviews of randomised controlled trials (RCTs) show that top medical journals continue to publish trials without requiring authors to report details for readers to evaluate early stopping decisions carefully. This article presents a systematic way of modelling and simulating interim monitoring decisions of RCTs. By taking an approach that is both general and rigorous, the proposed framework models and evaluates early stopping decisions of RCTs based on a clear and consistent set of criteria. The framework allows decision analysts to generate and quickly answer ‘what-if’ questions by simulating alternate trial scenarios. I illustrate the framework with a case study of an RCT that was stopped early due to harm. This was a trial of vitamin A supplement in relation to HIV transmission from mother-to-child through breastfeeding.
Keywords computer modeling and simulation  statistical evidence and inference  decision theory  counterfactual reasoning  Bayesian methods  randomized controlled trials  technology
Categories (categorize this paper)
Options
 Save to my reading list
Follow the author(s)
My bibliography
Export citation
Find it on Scholar
Edit this record
Mark as duplicate
Revision history Request removal from index Translate to english
 
Download options
PhilPapers Archive


Upload a copy of this paper     Check publisher's policy on self-archival     Papers currently archived: 11,361
External links
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
Through your library
References found in this work BETA

No references found.

Citations of this work BETA

No citations found.

Similar books and articles
Robyn Bluhm (2009). Some Observations on “Observational” Research. Perspectives in Biology and Medicine 52 (2):252-263.
Analytics

Monthly downloads

Added to index

2012-09-06

Total downloads

10 ( #148,332 of 1,102,717 )

Recent downloads (6 months)

1 ( #296,833 of 1,102,717 )

How can I increase my downloads?

My notes
Sign in to use this feature


Discussion
Start a new thread
Order:
There  are no threads in this forum
Nothing in this forum yet.