Study in a Sentence: A systematic review found that preclinical studies using animals fail to predict a drug’s potential to cause adverse health effects, despite being mandatory in safety and efficacy trials.
Healthy for Humans: A collaboration of researchers conducted a comprehensive evaluation of the in vivo and in vitro tests currently available to assess drug safety and compared their findings against actual adverse drug reactions (ADRs) among patients. The study focused on two diabetes drugs: troglitazone and rosiglitazone, neither of which showed a significant risk in either preclinical animal studies or human trials. However, in vitro data revealed considerable discrepancies in the two drugs’ toxicological profiles, suggesting illness and death due to ADRs could be prevented with available in vitro tests.
Redefining Research: Millions of ADRs occur every year, leading to more than one hundred thousand preventable deaths annually. Human-relevant technologies that are already available can help prevent ADRs and save patient and animal lives. However, this requires regulators to update their regulatory submission process and communicate guidance to industry so they can implement these technologies early on in the drug development process. The current system of drug development needs to be modernized and employ the use of tests that are more predictive of human outcomes.