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 - Databases, Factual/statistics & numerical data
KW - Early Termination of Clinical Trials
KW - Epidemiologic Studies
KW - Humans
KW - Publishing/statistics & numerical data
KW - Randomized Controlled Trials as Topic/statistics & numerical data
KW - Methodology
KW - Trial design
KW - Systematic review
KW - Trials stopped early for benefit
KW - Early termination of trials
KW - Randomized controlled trials
UR - http://www.scopus.com/inward/record.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
SN - 0895-4356
VL - 82
SP - 12
EP - 19
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
ER -