Question

Q1 .Researchers at GSK pharmaceutical company claims that they have developed a potential “candidate” drug to cure coronavirus infection. Using an experimental research design, explain how this drug should be tested in the clinical trials in order to ensure its safety and effectiveness.

Answer 1

Step 1: Select a set of voluneers having coronavirus infection.

Step 2: Randomly assign each of the volunteers to one of the two mutually exclusive groups: Group 1: Control Group and Group 2: Experimental Group. The random assignment will be carried out by an independent statistician. Neither the participant nor the researcher will know which participant is assigned to which group.Thus, the experiment is double blind.

Step 3: Group 1: Control Group participants will receive placebo, which resembles potential “candidate” drug but it has no effect. Group 2: Experimental Group. will receive potential “candidate” drug.

Step 4; The treatment (dosage, number of days etc.,) together with restrictions on food etc., will continue strictly as stipulated by the researchers at GSK pharmaceutical company

Step 5:

At the end of the exprimentation, all the participants will be tested for cure from coronavirus infection.

Step 6:
The statistician will consolidate the test results: those who have been treated with potential “candidate” drug and those who have been treated with placebo and their cure status.

Step 7:

Hypothesis Test will be conducted to test the significance of difference between cure from coronavirus infection between the two groups.

If the results indicate significant difference, we can conclude the safety and effectiveness of the potential “candidate” drug.