Physical Sciences and Mathematics Commons^™

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 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 Coello, Lorenzo Moja, Martin Walter, Kristian Thorlund, Paul Glasziou, Regina Kunz, Ignacio Ferreira-Gonzalez, Jason Busse, Xin Sun, Annette Kristiansen, Benjamin Kasenda, Osama Qasim-Agha, Gennaro Pagano, Hector Pardo-Hernandez, Gerard Urrutia, Mohammad Murad, Gordon Guyatt

Wayne State University Associated BioMed Central Scholarship

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 …