ReviewJournal of medical ethics2005
Stopping trials early for commercial reasons: the risk-benefit relationship as a moral compass.
Review in Journal of medical ethics, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed.
- Would tirofiban have been shown non-inferior to abciximab had the TENACITY trial not been terminated for financial reasons?Journal of interventional cardiology · 2013Trial
- Putting participants and study partners FIRST when clinical trials end early.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2022Article
- Practices and Attitudes of Swiss Stakeholders Regarding Investigator-Initiated Clinical Trial Funding Acquisition and Cost Management.JAMA network open · 2021Article
- Implications of product withdrawal on a post-approval pragmatic trial: The VOLUME study experience.Contemporary clinical trials communications · 2019Article
- Quantitative Framework for Retrospective Assessment of Interim Decisions in Clinical Trials.Medical decision making : an international journal of the Society for Medical Decision Making · 2016Article
- Wrongful termination: lessons from the Geron clinical trial.Stem cells translational medicine · 2014Article
- Risk-benefit analysis: from a logical point of view.Journal of bioethical inquiry · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Decisions by industry sponsors to end clinical trials early for commercial reasons have been the subject of controversy. I argue that the principal consideration in assessing these decisions ought to be the way in which the termination would affect the trial's risk-benefit relationship. If there is not yet sufficient benefit to be gained from the study to offset the risks to which participants were exposed and it is expected that important scientific information would be obtained if the trial were continued, early termination constitutes an unethical alteration of the risk-benefit relationship. This violates the grounds on which permission is given to conduct human research, patients consent to participate, and investigators agree to conduct studies. These knowable and avoidable changes in risk-benefit relationship should generally be seen as impermissible.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.