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Initiation and continuation of randomized trials after the publication of a trial stopped early for benefit asking the same study question: STOPIT-3 study design
Wayne State University Associated BioMed Central Scholarship
  • Gabriela J Prutsky, Knowledge and Evaluation Research Unit, Mayo Clinic
  • Juan Domecq, Knowledge and Evaluation Research Unit, Mayo Clinic
  • Patricia J Erwin, Knowledge and Evaluation Research Unit, Mayo Clinic
  • Matthias Briel, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel
  • Victor M Montori, Knowledge and Evaluation Research Unit, Mayo Clinic
  • Elie A Akl, McMaster University
  • Joerg J Meerpohl, German Cochrane Centre, Institute of Medical Biometry and Medical Informatics, University Medical Center Freiburg
  • Dirk Bassler, Center for Pediatric Clinical Studies, University Children’s Hospital Tuebingen
  • Stefan Schandelmaier, Academy of Swiss Insurance Medicine, University Hospital Basel
  • Stephen D Walter, McMaster University
  • Qi Zhou, McMaster University
  • Pablo Coello, Iberoamerican Cochrane Center, CIBER de Epidemiología y Salud Pública
  • Lorenzo Moja, University of Milan
  • Martin Walter, University Hospital Bern
  • Kristian Thorlund, McMaster University
  • Paul Glasziou, University of Oxford
  • Regina Kunz, Academy of Swiss Insurance Medicine, University Hospital Base
  • Ignacio Ferreira-Gonzalez, Vall d’Hebron Hospital and CIBER de Epidemiología y Salud Publica (CIBERESP)
  • Jason Busse, McMaster University
  • Xin Sun, Center for Health Research, Kaiser Permanente Northwest
  • Annette Kristiansen, Norwegian Knowledge Centre for the Health Services
  • Benjamin Kasenda, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel
  • Osama Qasim-Agha, Knowledge and Evaluation Research Unit, Mayo Clinic
  • Gennaro Pagano, Federico II University of Naples
  • Hector Pardo-Hernandez, Iberoamerican Cochrane Center, CIBER de Epidemiología y Salud Pública
  • Gerard Urrutia, Epidemiology and Public Health CIBER (CIBERESP), Hospital de la Sant Pau Creu i
  • Mohammad Murad, Knowledge and Evaluation Research Unit, Mayo Clinic
  • Gordon Guyatt, McMaster University
Document Type
Article
Publication Date
1-1-2013
Abstract

Abstract

Background

Randomized control trials (RCTs) stopped early for benefit (truncated RCTs) are increasingly common and, on average, overestimate the relative magnitude of benefit by approximately 30%. Investigators stop trials early when they consider it is no longer ethical to enroll patients in a control group. The goal of this systematic review is to determine how investigators of ongoing or planned RCTs respond to the publication of a truncated RCT addressing a similar question.

Methods/design

We will conduct systematic reviews to update the searches of 210 truncated RCTs to identify similar trials ongoing at the time of publication, or started subsequently, to the truncated trials ('subsequent RCTs’). Reviewers will determine in duplicate the similarity between the truncated and subsequent trials. We will analyze the epidemiology, distribution, and predictors of subsequent RCTs. We will also contact authors of subsequent trials to determine reasons for beginning, continuing, or prematurely discontinuing their own trials, and the extent to which they rely on the estimates from truncated trials.

Discussion

To the extent that investigators begin or continue subsequent trials they implicitly disagree with the decision to stop the truncated RCT because of an ethical mandate to administer the experimental treatment. The results of this study will help guide future decisions about when to stop RCTs early for benefit.

Citation Information
Prutsky et al.: Initiation and continuation of randomized trials after the publication of a trial stopped early for benefit asking the same study question: STOPIT-3 study design. Trials 2013 14:335.