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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Randomized trials addressing a similar question are commonly published after a trial stopped early for benefit
M Hassan Murad1, Gordon H Guyatt2, Juan Pablo Domecq3
1Evidence-Based Practice Center, Mayo Clinic, 200, 1st street, Rochester, MN 55905, USA; Knowledge and Evaluation Research Unit, Mayo Clinic, 200, 1st street, Rochester, MN 55905, USA; Division of Preventive Medicine, Mayo Clinic, 200, 1st street, Rochester, MN 55905, USA.
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.
Insights
Nearly half of clinical trials stopped early for benefit were followed by new trials. This suggests researchers may doubt early stopping decisions, highlighting a need for stricter benefit-stopping criteria in clinical research.
Area of Science:
- Clinical Trial Design
- Medical Research Ethics
- Evidence-Based Medicine
Background:
- Trials stopped early for benefit aim to expedite evidence dissemination.
- Subsequent trials may arise due to skepticism or differing research questions.
Purpose of the Study:
- To investigate the rate and reasons for subsequent trials following early stopping for benefit.
- To assess investigator responses to early-benefit trial publications.
Main Methods:
- Systematic search of multiple databases for trials published up to August 2015.
- Independent review and data extraction of identified trials.
Main Results:
- 207 trials stopped early for benefit were identified.
- 49% of these were followed by 262 subsequent trials.
- Reasons for subsequent trials included different populations, small sample sizes, and inconsistency with other evidence.
Conclusions:
- Approximately half of trials stopped early for benefit were followed by similar trials.
- This indicates potential skepticism regarding early stopping decisions.
- A more rigorous threshold for stopping trials early for benefit is recommended.
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