Careers in academia: Different options
Guest contributor Gaia Donati … Read more
US research ethics agency upholds decision on informed consent
United States regulators are standing by their decision that parents were not properly informed of the risks of clinical trials in which premature babies received different levels of oxygen supplementation. Read more
Discrepancies in serious adverse event reporting may distort the medical evidence base
The worst thing that can happen to a person participating in a clinical trial is what’s known as a ‘serious adverse event’, which can describe anything from permanent kidney damage or liver failure to hospitalization or even death. Federal law in the US mandates that researchers conducting trials of drugs or other products regulated by the country’s Food and Drug Administration (FDA) report adverse events on ClinicalTrials.gov, a data repository open to the public. But a new study shows that many of these serious adverse events don’t appear in medical journals, making some interventions seem more favorable than they may actually be. Read more
One in six clinical trials might fall outside federal oversight, study estimates
Bioethicists have long known about a potential regulatory loophole that excludes certain types of clinical trials from federal regulations designed to protect the safety of human research subjects in the US. However, the number of clinical trials that fell into this gap remained unknown. Now, a letter published online today in the Journal of the American Medical Association reveals just how many trials may fall outside federal government supervision at present. Read more
