Antibiotics - Developing Drugs: Trials and Placebos (GCSE Biology)
Developing Drugs: Trials and Placebos
Clinical Trials
Clinical trials are research studies which are used to investigate scientific theories. Many drugs enter clinical trials to test for safety and efficacy, and only a small proportion actually get approved for national use. There are five stages of testing for a new drug, and we will go through each of them below:
1. Preclinical Testing – Lab Testing
The first stage is preclinical testing and involves computer modelling and testing outside of the body in vitro. This stage aims to make sure that the drug is safe and effective before introducing it into animals or humans.
2. Preclinical Testing – Animal Testing
The next part of the preclinical stage is testing on animals. This stage poses ethical problems, because some people are against animal testing. However, animal testing is still necessary in the UK before the introduction of any drug, other than cosmetics and tobacco, into the market. After passing this stage, clinical testing on human healthy volunteers is done
3. Clinical Testing – Phase 1
The first stage of clinical testing of a drug on humans uses a very low dose. The number of patients is quite small (15 20 participants) and the aim is to check if the treatment is safe and to find the right dose. We start with a very low dose, and then the dose is slowly titrated up to find an optimum dose, balancing safety and efficacy.
4. Clinical Testing – Phase 2
The second stage of clinical testing involves testing how well the drug works in actually treating patients – the efficacy. This is a larger test involving more participants (20-150 participants).
5. Clinical Testing – Phase 3
The third stage of clinical testing involves comparison of the drug to the current treatment in a large trial. This trial can involve 100s or 1000s of participants.
Some trials are double blind. In double-blind trials, some of the patients are given a placebo, a sugar pill, so they do not know that they are not getting the medication, in order to compare against those who are getting the medication. In these trials, the scientists do not know either who is getting what treatment as the groups are randomised.
Antibiotics are medications that fight bacterial infections. They work by killing or stopping the growth of bacteria in your body.
Antibiotics are developed through a long and complex process that involves laboratory research, animal testing, and clinical trials. Scientists first identify the specific bacteria causing an infection, then they search for a substance that can kill or stop the growth of that bacteria. The substance is then tested in the lab and in animals to see if it is safe and effective.
A clinical trial is a study in which a new drug is tested in people to see if it is safe and effective. During a clinical trial, participants are divided into two groups: one group receives the experimental drug, while the other group receives a placebo (a fake treatment).
A placebo is used in clinical trials to compare the results of the experimental drug with a control group. By comparing the results of the two groups, scientists can determine if the experimental drug is having a real effect on the participants.
A double-blind trial is a type of clinical trial where neither the participants nor the researchers know which group is receiving the experimental drug and which is receiving the placebo. This helps to reduce any biases that may influence the results of the trial.
After a clinical trial is complete, the results are analyzed to determine if the experimental drug is safe and effective. If the drug is found to be safe and effective, it can be approved by the relevant regulatory body and made available to the public.
Clinical trials are important for developing antibiotics because they help to determine if the experimental drug is safe and effective for treating bacterial infections in humans. Without clinical trials, we would not have the antibiotics that we have today, and many people would still be suffering from bacterial infections.
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