Welcome development: The Hindu Editorial on the ICMR and Controlled Human Infection Studies
The HinduWith the Bioethics Unit of the Indian Council of Medical Research placing a consensus policy statement on Controlled Human Infection Studies for comments, India has taken the first step in clearing the deck for such studies to be undertaken here. CHIS, also called human challenge studies, where healthy volunteers are intentionally exposed to a disease-causing microbe in a highly controlled and monitored environment, has been carried out for hundreds of years, an example being the yellow fever study in the early 1900s to establish that mosquitoes transmit the virus. Importantly, human challenge studies are not done as an alternative to phase-3 efficacy trials, but to help select the best candidate for testing in a conventional phase-3 clinical trial. Phase-3 clinical trials that follow human challenge studies often require fewer volunteers, speeding up the development process.