Clinical trials Current Affairs - 2020
On June 4, 2020, the World Health Organization resumed its clinical trials on exploring whether the Hydroxychloroquine (HCQ) drug is effective in treating COVID-19.
The clinical trial on Malaria Drug HCQ was earlier put on hold by the World Health Organization raising concerns of its efficacy.
Why were the trials put off?
The clinical trials were put off by the world organization considering the safety of the patients. WHO raised concerns about people in different parts of the world taking the drugs without proper medical guidance.
Why are the trials resumed now?
The trials were paused to analyze the results of using the drugs so far. The board set up by the WHO has reviewed the available mortality data of COVID-19 and now found that there are no reasons to stop the trials. There are more than 400 hospitals that are participating in the trials from 35 countries. It includes hospitals from Gujarat as well.
Why did the issue begin?
The Food and Drug Administration of US and other chief editorials like the Lancet have warned about the use of drugs without the advice of a medical professional. Thus, the WHO stepped in to make sure if the trials can be proceeded based on the success rate of the drug so far.
Tags: Clinical trials • COVID-19 • hydroxychloroquine • Malaria • U.S. Food and Drug Administration
The World Health Organization (WHO) recently announced eight candidates to enter human trials. Several people step forward to participate in human challenge trial as the race to develop new vaccine for the virus is increasing.
What is Human Challenge Trial?
The trial involves infecting volunteers intentionally with COVID-19 virus. This is done to speed up the process of vaccine development.
The Vaccine development takes several years to develop through three phases of clinical trials. This includes
Phase 1: During this phase small groups of people receive the vaccine
Phase 2: Vaccine is given to those people whose characteristics are similar to those for whom the new vaccine is intended.
Phase 3: Vaccine is given to several thousands to test the safety and efficacy. During this phase, the participants either receive placebo or vaccine. Placebo is something that looks like treatment but is not in reality. It can be a sugar solution or saline.
The Human Challenge Trial is not new. Earlier, similar trials were conducted for malaria as well.
The main benefit of the human challenge trial is that it accelerates testing. Many efficacious vaccines shall be available more quickly. Also, the number of people required in phase 3 of these trials is less than the regular trials.