07 Jun 2021
Setting it Straight: the ultimate clinical trial
Over the past weeks, we’ve been considering the various types of trials, both in animals and in humans, that are required before a drug or vaccine can be approved for human use (#53-#59). That discussion ended with a brief account of the penultimate trial, in this case the double-blind, randomised Phase III vaccine trial that involve tens of thousands of volunteers who vary in age, ethnicity, gender and, as such trials can only be done in sites where the virus is circulating at a high level, location (#59). All that data has to be cumulated, analysed and presented by the company conducting the trial – with central input from the trial’s fully independent DSMB (data safety monitoring board) – to key regulatory agencies like the US FDA, the European EMA and Australia’s TGA.