Human Studies as Alternatives

In 2006, a humanised monoclonal antibody that was tested in macaques and deemed to present no overt adverse risk to human volunteers, caused six otherwise healthy young men to be severely affected by what is thought to be a cytokine storm.

FRAME analysed this unfortunate incident and looked at reasons why animal studies were not able to predict the risks that materialised. One of the most important conclusions was that in the case of human-specific drugs with complex mechanisms of action, most, if not all, animal models are inadequate.

A second conclusion was that non-animal studies are needed which can help with the interpretation of information from animal studies. In many cases, such methods simply do not yet exist.

Other issues addressed were the way in which clinical trials are conducted, including the interval between giving a test drug to each volunteer, dose-setting and whether studies that involve giving very low doses (microdoses) locally, should preceed classical phase I clinical trials.