TY - JOUR
T1 - Initiation and continuation of randomized trials after the publication of a trial stopped early for benefit asking the same study question
T2 - STOPIT-3 study design
AU - Prutsky, Gabriela J.
AU - Domecq, Juan P.
AU - Erwin, Patricia J.
AU - Briel, Matthias
AU - Montori, Victor M.
AU - Akl, Elie A.
AU - Meerpohl, Joerg J.
AU - Bassler, Dirk
AU - Schandelmaier, Stefan
AU - Walter, Stephen D.
AU - Zhou, Qi
AU - Coello, Pablo A.
AU - Moja, Lorenzo
AU - Walter, Martin
AU - Thorlund, Kristian
AU - Glasziou, Paul
AU - Kunz, Regina
AU - Ferreira-Gonzalez, Ignacio
AU - Busse, Jason
AU - Sun, Xin
AU - Kristiansen, Annette
AU - Kasenda, Benjamin
AU - Qasim-Agha, Osama
AU - Pagano, Gennaro
AU - Pardo-Hernandez, Hector
AU - Urrutia, Gerard
AU - Murad, Mohammad H.
AU - Guyatt, Gordon
PY - 2013/10/16
Y1 - 2013/10/16
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84885437144&partnerID=8YFLogxK
U2 - 10.1186/1745-6215-14-335
DO - 10.1186/1745-6215-14-335
M3 - Article
C2 - 24131702
AN - SCOPUS:84885437144
SN - 1745-6215
VL - 14
JO - Trials
JF - Trials
IS - 1
M1 - 335
ER -