Title
Randomized trials addressing a similar question are commonly published after a trial stopped early for benefit
Date Issued
01 February 2017
Access level
open access
Resource Type
review
Author(s)
Murad M.H.
Guyatt G.H.
Vernooij R.W.M.
Erwin P.J.
Meerpohl J.J.
Akl E.A.
Mueller K.
Bassler D.
Schandelmaier S.
Walter S.D.
Busse J.W.
Kasenda B.
Pagano G.
Pardo-Hernandez H.
Wang Z.
Briel M.
Publisher(s)
Elsevier USA
Abstract
Objective We explored how investigators of ongoing or planned trials respond to the publication of a trial stopped early for benefit addressing a similar question. Study Design and Setting We searched multiple databases from the date of publication of the truncated trial through August, 2015. Independent reviewers selected trials and extracted data. Results We identified 207 trials truncated for early benefit; of which 102 (49%) were followed by subsequent trials (262 subsequent trials, median 2 per truncated trial, range 1–13). Only 99 (38%) provided a rationale justifying conducting a trial despite prior stopping. The top reasons were to address different population or setting (33%), skepticism of truncated trials findings because of small sample size (12%), inconsistency with other evidence (11%), or increased risk of bias (7%). We did not identify significant associations between subsequent trials and characteristics of truncated ones (risk of bias, precision, funding, or rigor of stopping decision). Conclusion About half of the trials stopped early for benefit were followed by subsequent trials addressing a similar question. This suggests that future trialists may have been skeptic about the decision to stop prior trials. A more rigorous threshold for stopping early for benefit is needed.
Start page
12
End page
19
Volume
82
Language
English
OCDE Knowledge area
Medicina clínica
Scopus EID
2-s2.0-85010282475
PubMed ID
Source
Journal of Clinical Epidemiology
ISSN of the container
08954356
Sponsor(s)
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung 164750 SNF
Sources of information: Directorio de Producción Científica Scopus