TY - JOUR
T1 - Randomized trials addressing a similar question are commonly published after a trial stopped early for benefit
AU - Murad, M. Hassan
AU - Guyatt, Gordon H.
AU - Domecq, Juan Pablo
AU - Vernooij, Robin W.M.
AU - Erwin, Patricia J.
AU - Meerpohl, Joerg J.
AU - Prutsky, Gabriela J.
AU - Akl, Elie A.
AU - Mueller, Katharina
AU - Bassler, Dirk
AU - Schandelmaier, Stefan
AU - Walter, Stephen D.
AU - Busse, Jason W.
AU - Kasenda, Benjamin
AU - Pagano, Gennaro
AU - Pardo-Hernandez, Hector
AU - Montori, Victor M.
AU - Wang, Zhen
AU - Briel, Matthias
N1 - Publisher Copyright:
© 2016 Elsevier Inc.
PY - 2017/2/1
Y1 - 2017/2/1
N2 - 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.
AB - 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.
KW - Early termination of trials
KW - Methodology
KW - Randomized controlled trials
KW - Systematic review
KW - Trial design
KW - Trials stopped early for benefit
UR - http://www.scopus.com/inward/record.url?scp=85010282475&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85010282475&partnerID=8YFLogxK
U2 - 10.1016/j.jclinepi.2016.10.006
DO - 10.1016/j.jclinepi.2016.10.006
M3 - Review article
C2 - 27832953
AN - SCOPUS:85010282475
SN - 0895-4356
VL - 82
SP - 12
EP - 19
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
ER -