24 May 2021
Setting it Straight: Confronting the virus: human challenge studies and Phase II trials
Over (#53 - #57) the past weeks we’ve looked at basic issues, including ethical approvals, that determine the conduct of Observational (#54) and double blind, randomised, Interventional clinical trials (#56, #57). Earlier discussion of Phase I safety trials mentioned the current absence of background SARS-CoV-2 infection in the Australian community, plus advantages conferred by our comprehensive, tax-payer-funded Medicare scheme. A further strength when it comes to Phase I clinical trials is the ethnic diversity of our population. Regulatory authorities in different Nation States are increasingly mandating that clinical trial data must be available for their predominant ethnic and cultural groups, not just for Caucasians, especially Caucasian males.