Predicting Harms and Benefits in Translational Trials: Ethics, Evidence, and Uncertainty
2011
Understanding Risks in Clinical Trials
publication
Author Information
Author(s): James V. Lavery
Primary Institution: Centre for Research on Inner City Health & Centre for Global Health Research, Keenan Research Centre in the Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Canada
Hypothesis
How can institutional review boards better interpret preclinical data?
Conclusion
The study suggests that institutional review boards need to pay more attention to the quality of preclinical evidence to make better predictions about risks and benefits in clinical trials.
Supporting Evidence
- IRBs often struggle to predict net harm or benefit from clinical trial protocols.
- Kimmelman and London argue that IRB members may overlook threats to validity in preclinical studies.
- The TGN1412 trial illustrates the potential dangers of relying on animal data without proper scrutiny.
Takeaway
This study talks about how people who review medical trials need to be careful when looking at animal studies to make sure they understand the risks and benefits for humans.
Digital Object Identifier (DOI)
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