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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
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 con...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3874848/ https://www.ncbi.nlm.nih.gov/pubmed/24131702 http://dx.doi.org/10.1186/1745-6215-14-335 |
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author | Prutsky, Gabriela J Domecq, Juan Pablo Erwin, Patricia J Briel, Matthias Montori, Victor M Akl, Elie A Meerpohl, Joerg J Bassler, Dirk Schandelmaier, Stefan Walter, Stephen D Zhou, Qi Coello, Pablo Alonso Moja, Lorenzo Walter, Martin Thorlund, Kristian Glasziou, Paul Kunz, Regina Ferreira-Gonzalez, Ignacio Busse, Jason Sun, Xin Kristiansen, Annette Kasenda, Benjamin Qasim-Agha, Osama Pagano, Gennaro Pardo-Hernandez, Hector Urrutia, Gerard Murad, Mohammad Hassan Guyatt, Gordon |
author_facet | Prutsky, Gabriela J Domecq, Juan Pablo Erwin, Patricia J Briel, Matthias Montori, Victor M Akl, Elie A Meerpohl, Joerg J Bassler, Dirk Schandelmaier, Stefan Walter, Stephen D Zhou, Qi Coello, Pablo Alonso Moja, Lorenzo Walter, Martin Thorlund, Kristian Glasziou, Paul Kunz, Regina Ferreira-Gonzalez, Ignacio Busse, Jason Sun, Xin Kristiansen, Annette Kasenda, Benjamin Qasim-Agha, Osama Pagano, Gennaro Pardo-Hernandez, Hector Urrutia, Gerard Murad, Mohammad Hassan Guyatt, Gordon |
author_sort | Prutsky, Gabriela J |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-3874848 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-38748482013-12-31 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 Prutsky, Gabriela J Domecq, Juan Pablo Erwin, Patricia J Briel, Matthias Montori, Victor M Akl, Elie A Meerpohl, Joerg J Bassler, Dirk Schandelmaier, Stefan Walter, Stephen D Zhou, Qi Coello, Pablo Alonso Moja, Lorenzo Walter, Martin Thorlund, Kristian Glasziou, Paul Kunz, Regina Ferreira-Gonzalez, Ignacio Busse, Jason Sun, Xin Kristiansen, Annette Kasenda, Benjamin Qasim-Agha, Osama Pagano, Gennaro Pardo-Hernandez, Hector Urrutia, Gerard Murad, Mohammad Hassan Guyatt, Gordon Trials Study Protocol 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. BioMed Central 2013-10-16 /pmc/articles/PMC3874848/ /pubmed/24131702 http://dx.doi.org/10.1186/1745-6215-14-335 Text en Copyright © 2013 Prutsky et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Study Protocol Prutsky, Gabriela J Domecq, Juan Pablo Erwin, Patricia J Briel, Matthias Montori, Victor M Akl, Elie A Meerpohl, Joerg J Bassler, Dirk Schandelmaier, Stefan Walter, Stephen D Zhou, Qi Coello, Pablo Alonso Moja, Lorenzo Walter, Martin Thorlund, Kristian Glasziou, Paul Kunz, Regina Ferreira-Gonzalez, Ignacio Busse, Jason Sun, Xin Kristiansen, Annette Kasenda, Benjamin Qasim-Agha, Osama Pagano, Gennaro Pardo-Hernandez, Hector Urrutia, Gerard Murad, Mohammad Hassan Guyatt, Gordon 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3874848/ https://www.ncbi.nlm.nih.gov/pubmed/24131702 http://dx.doi.org/10.1186/1745-6215-14-335 |
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