ArticleJournal of medical ethics2016
Assessing risk/benefit for trials using preclinical evidence: a proposal.
Article in Journal of medical ethics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.
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
23 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Recommendations for robust and reproducible preclinical research in personalised medicine.BMC medicine · 2023Guideline
- Pooled it
- Innovative Multidimensional Quantitative Benefit-Risk Model for Effective Decision Making in Research and Development for Biopharmaceutical Industry.Therapeutic innovation & regulatory science · 2026Article
- More ethics in the laboratory, please! Scientists' perspectives on ethics in the preclinical phase.Accountability in research · 2025Article
- Preclinical assessment for translation to humans: The PATH approach for assessing supporting evidence for early-phase trials and innovative care.Med (New York, N.Y.) · 2024Review
- Optimizing mesenchymal stem cell extracellular vesicles for chronic wound healing: Bioengineering, standardization, and safety.Regenerative therapy · 2024Review
- Building reproducible bridges to cross the "valley of death".The Journal of clinical investigation · 2024Article
- Ethical challenges for a new generation of early-phase pediatric gene therapy trials.Genetics in medicine : official journal of the American College of Medical Genetics · 2021Review
- Do we really know how many clinical trials are conducted ethically? Why research ethics committee review practices need to be strengthened and initial steps we could take to strengthen them.Journal of medical ethics · 2021Review
- Levelling the Translational Gap for Animal to Human Efficacy Data.Animals : an open access journal from MDPI · 2020Review
- Rescuing Informed Consent: How the new "Key Information" and "Reasonable Person" Provisions in the Revised U.S. Common Rule open the door to long Overdue Informed Consent Disclosure Improvements and why we need to walk Through that door.Science and engineering ethics · 2020Article
- Systematic review of guidelines for internal validity in the design, conduct and analysis of preclinical biomedical experiments involving laboratory animals.BMJ open science · 2020Article
- Ethical development of stem-cell-based interventions.Nature medicine · 2019Review
- 3Rs missing: animal research without scientific value is unethical.BMJ open science · 2019Article
- Epigenetics Changes Nothing: What a New Scientific Field Does and Does Not Mean for Ethics and Social Justice.Public health ethics · 2018Article
- Preclinical efficacy studies in investigator brochures: Do they enable risk-benefit assessment?PLoS biology · 2018Article
- Ethics review of studies during public health emergencies - the experience of the WHO ethics review committee during the Ebola virus disease epidemic.BMC medical ethics · 2017Article
- Consider drug efficacy before first-in-human trials.Nature · 2017Article
- The Role of Intuition in Risk/Benefit Decision-Making in Human Subjects Research.Accountability in research · 2017Article
- First-in-human Phase 1 CRISPR Gene Editing Cancer Trials: Are We Ready?Current gene therapy · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
Abstract
Moral evaluation of risk/benefit in early phase studies requires assessing the clinical promise of a candidate intervention using preclinical evidence. Yet, there is little to guide ethics committees, investigators, sponsors or other stakeholders morally charged with making these assessments ('evaluators'). In what follows, we draw on published guidelines for preclinical study design to develop a structured process for assessing the clinical promise of new interventions. In the first step, evaluators gather all relevant preclinical studies, assess the magnitude of treatment effects and determine clinical promise in light of various threats to valid clinical inference. In the second step, evaluators adjust the assessments of clinical promise from preclinical studies by examining how other agents in the same reference class-and supported by similar evidence-have fared in clinical development. Assessments of clinical promise can then be fed into the moral evaluation of risk and benefit in early phase trials. Though our approach has limitations, it offers a systematic and transparent method for assessing risk/benefit in early phase trials of novel interventions.
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.