Tuesday, February 4, 2020
Clinical trials for CORONA VIRUS underway
With everyone around the globe on the watch for the novel corona virus, as the Laboratory insider, it's a privilege to inform you, that work has begun at multiple health organisations and research institutions to avail remedy against this new alarming virus.
One may ask, "WHAT DOES IT TAKE TO CARRY OUT A CLINICAL TRIAL and WHAT IS A CLINICAL TRIAL?"
1. Clinical Trial:
It is a research investigation in which humans (people) volunteer to test new treatments, interventions or tests as a means of detecting. treating, managing or preventing various diseases or medical conditions. It evaluates how people respond to the new intervention and looks out for the side effects that may occur.
2.What does it take to carry out a clinical trial?
A clinical trial involves about four phases for human clinical trials and we'll look at them briefly;
a] Phase I:
These studies evaluate the safety of the substance or drug and marks the initial phase of testing. It involves assessing the effect of the drug on human subjects thus its absorption, metabolism and excretion plus side effects occurring while dosage increases.
b] Phase II:
It is the second phase of testing and studies assess the efficacy of the drug. It involves a test group of patients that receive the experimental drug and a control group of patients that receives the standard treatment.
c] Phase III:
This study also involves randomized and blind testing whereby hundreds to thousand of patients are given the drug. The large sample size enables pharmaceutical companies and the FDA to thoroughly understand the effectiveness of the drug.
It is after this stage that the pharmaceutical company may seek FDA approval for marketing the drug.
d] Phase IV:
These studies are carried out after the drug , device or substance has been approved for consumer sale. This aims at comparing effectiveness with other drugs already on market and monitoring the drug's long term effectiveness.
In this phase, restrictions of usage could be imposed on the drug or device and also, it could be taken off the market depending on the findings from the study.
So now, two questions have been answered today and we'll end here for today.
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