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.

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 / G.J. Prutsky, J.P. Domecq, P.J. Erwin, M. Briel, V.M. Montori, E.A. Akl, J.J. Meerpohl, D. Bassler, S. Schandelmaier, S.D. Walter, Q. Zhou, P.A. Coello, L. Moja, M. Walter, K. Thorlund, P. Glasziou, R. Kunz, I. Ferreira-Gonzalez, J. Busse, X. Sun, A. Kristiansen, B. Kasenda, O. Qasim-Agha, G. Pagano, H. Pardo-Hernandez, G. Urrutia, M.H. Murad, G. Guyatt. - In: TRIALS. - ISSN 1745-6215. - 14:1(2013), pp. 335.1-335.8. [10.1186/1745-6215-14-335]

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

L. Moja;
2013

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.
Protocol; Randomized controlled trials stopped early for benefit; RCT; Systematic review; Humans; Information Dissemination; Randomized Controlled Trials as Topic; Time Factors; Early Termination of Clinical Trials; Evidence-Based Medicine; Periodicals as Topic; Research Design; Medicine (miscellaneous); Pharmacology (medical)
Settore MED/42 - Igiene Generale e Applicata
Article (author)
File in questo prodotto:
File Dimensione Formato  
STOPIT 3 TRIAL DESIGN Trials Initiation and continuation of randomized trials after the publication of a trial stopped early for benefit.pdf

accesso aperto

Tipologia: Publisher's version/PDF
Dimensione 964.47 kB
Formato Adobe PDF
964.47 kB Adobe PDF Visualizza/Apri
Pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/251995
Citazioni
  • ???jsp.display-item.citation.pmc??? 1
  • Scopus 4
  • ???jsp.display-item.citation.isi??? 4
social impact