2
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: not found

      Continuous safety monitoring for randomized controlled clinical trials with blinded treatment information. Part 4: One method.

      1
      Contemporary clinical trials
      Elsevier BV

      Read this article at

      ScienceOpenPublisherPubMed
      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Standard methods for testing safety data are needed to ensure the safe conduct of clinical trials. In particular, objective rules for reliably identifying unsafe treatments need to be put into place to help protect patients from unnecessary harm. DMCs are uniquely qualified to evaluate accumulating unblinded data and make recommendations about the continuing safe conduct of a trial. However, it is the trial leadership who must make the tough ethical decision about stopping a trial, and they could benefit from objective statistical rules that help them judge the strength of evidence contained in the blinded data. We design objective early stopping rules for harm that act as continuous safety screens for randomized controlled clinical trials using the accumulating data with blinded treatment information, which could be used by anyone, including trial investigators and trial leadership. A Bayesian framework, with emphasis on the likelihood function, is used to allow for continuous monitoring without adjusting for multiple comparisons. Close collaboration between the statistician and the clinical investigators will be needed in order to design safety screens with good operating characteristics. Though the math underlying this procedure may be computationally intensive, implementation of the statistical rules will be easy and the continuous screening provided will give suitabley early warning when real problems were to emerge. Trial investigators and trial leadership need these safety screens to help them to effectively monitor the ongoing safe conduct of clinical trials with blinded data.

          Related collections

          Author and article information

          Journal
          Contemp Clin Trials
          Contemporary clinical trials
          Elsevier BV
          1559-2030
          1551-7144
          Sep 2011
          : 32 Suppl 1
          Affiliations
          [1 ] Astellas Pharma Global Development, 3 Parkway N, Deerfield, IL 60015, USA. greg.ball@us.astellas.com
          Article
          S1551-7144(11)00134-0
          10.1016/j.cct.2011.05.008
          21651993
          1c40a146-1865-41fc-8aaf-0efe4f77c437
          Copyright © 2011 Elsevier Inc. All rights reserved.
          History

          Comments

          Comment on this article