Predicting Harms and Benefits in Translational Trials
Author Information
Author(s): Jonathan Kimmelman, Alex John London
Primary Institution: McGill University, Montreal, Quebec, Canada; Carnegie Mellon University, Pittsburgh, Pennsylvania, United States of America
Hypothesis
How can ethical decision-making in clinical trials be improved by better predictions of risks and benefits?
Conclusion
The study suggests that decision-makers should broaden their evidence base and improve the quality of preclinical research to make better ethical decisions in clinical trials.
Supporting Evidence
- Ethical judgments in clinical trials depend on accurate predictions of harm and benefit.
- Many preclinical studies do not adequately address threats to validity.
- Only 5% of products entering trials are eventually licensed.
Takeaway
This study says that when testing new medicines, researchers need to look at more evidence and make sure their tests are done well to keep patients safe.
Potential Biases
There is a risk of bias due to reliance on insufficiently validated preclinical studies.
Limitations
The study highlights the limitations of current preclinical research practices and the narrow evidence base used for predictions.
Digital Object Identifier (DOI)
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