There are several non-prescription cold and influenza medications currently bein
ID: 8171 • Letter: T
Question
There are several non-prescription cold and influenza medications currently being marketed. At least one of these medications has been subjected to human clinical trials. The manufacturer of this drug makes the following two claims that are derived directly from these trials. The medications "is safe and well tolerated", it "reduces the seventy and duration of cold and flu symptoms". Outline an experimental procedure, in reasonable detail, that could have been used in a stage 3 human clinical trial to establish the efficacy of the cold and flu medication cited above. Include all of the most important criteria that you can think of. For example, it would have to be a randomized double-blind procedure; what else? What measurements did the experimenters have to make in order to obtain the data necessary to support the two conclusions listed above? Comment on the reliability of such clinical trials. How confident are you about the data collected? Explain your reasoning.Explanation / Answer
1. -In stage 3 of human clinical trails hundreds or thousands of people are involved in the test. The time taken will be long often several years.
-It involve randomized and blind testing in several hundred to several thousand patients.
In stage 3 conditions like dosage of drug, safety and effectiveness should be tested and studied.
A control group of patients are used as standard for comparison.
-Stage 3 provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug or device, the benefits and the range of possible adverse reactions.
- 70% to 90% of drugs that enter Phase III studies successfully complete this phase of testing. Once Phase III is complete, a pharmaceutical company can request FDA approval for marketing the drug.
2. Reliability of drugs will be more once they pass the stage 3 of human clinical trails. Many tests will be conducted and approval from FDA is taken. They are marketed after testing on many human beings, so they can be trusted. The data collected is also authentic as researchers and officials will be dealing with them.
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