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

Gabriela J. Prutsky, Juan P. Domecq, Patricia J. Erwin, Matthias Briel, Victor M. Montori, Elie A. Akl, Joerg J. Meerpohl, Dirk Bassler, Stefan Schandelmaier, Stephen D. Walter, Qi Zhou, Pablo A. Coello, Lorenzo Moja, Martin Walter, Kristian Thorlund, Paul Glasziou, Regina Kunz, Ignacio Ferreira-Gonzalez, Jason Busse, Xin SunAnnette Kristiansen, Benjamin Kasenda, Osama Qasim-Agha, Gennaro Pagano, Hector Pardo-Hernandez, Gerard Urrutia, Mohammad H. Murad, Gordon Guyatt

Research output: Contribution to journalArticle

4 Scopus citations

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.

Original languageEnglish (US)
Article number335
JournalTrials
Volume14
Issue number1
DOIs
StatePublished - Oct 16 2013

Keywords

  • Protocol
  • RCT
  • Randomized controlled trials stopped early for benefit
  • Systematic review

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

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    Prutsky, G. J., Domecq, J. P., Erwin, P. J., Briel, M., Montori, V. M., Akl, E. A., Meerpohl, J. J., Bassler, D., Schandelmaier, S., Walter, S. D., Zhou, Q., Coello, P. A., Moja, L., Walter, M., Thorlund, K., Glasziou, P., Kunz, R., Ferreira-Gonzalez, I., Busse, J., ... Guyatt, G. (2013). 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, 14(1), [335]. https://doi.org/10.1186/1745-6215-14-335