Every antibiotic and drug you’ve ever been prescribed by doctors has gone threw testing and trials to ensure its effectiveness and safeness.
Before we start testing and developing drugs we study the pathogen.
We must know how the pathogen, grows, multiplies, causes damage and lives.
Once we have researched the pathogen, we begin human cell trials.
We cultivate human cells and grow them in a laboratory. Scientists try out different concentrations of the drug and study the effects on the cells.
These tests check how well the chemical works against the disease and if it is safe for the cells.
Stage 2 is animal testing.
If the drug passes human cell testing, it progresses to animal testing.
We do animal testing to see how the drug affects a whole organism.
Stage 3 is clinical trials.
The last stage is clinical trails. The drug is tested on people with the disease.
Quick Questions
1. What is a Drug?
2. What are the 3 stages to testing a drug.
3. Why is developing a new drug expensive
Human trials are not as simple as giving a group of people a drug and seeing the effect.
Often we divide the participants randomly into groups. One group will be given the drug, while the other group will not be given the drug (Control group). The control group can be given a placebo. A pill designed to look like the drug, but do nothing.
There are 3 types of trials.
Double blind - Both doctor and patient don’t know who has the drug
Blind - Only the doctor knows who has the drug
Open trial - Both patient and doctor know
A random double blind study is considered the best type of clinical trial. If the patient or doctor knew who is taking the drug, the results could be altered.
However, in rare cases, there may be no control group and all patients will receive the treatment.
Questions
1. What is a placebo and why is it used?
2. Why is it necessary to have a control group
3. What are the 3 types of trials and explain them
4. What are the ethical issues when doing human drug testing.
5. What could have been done prior to Thalidomide being released.
6. Under what circumstances is a no placebo required.
7. What is the best type of testing and why
Extension Task
8. Create a pamphlet or leaflet explaining to someone what to expect while entering a clinical trial and the steps involved in drug testing.
Thalidomide was a drug released in 1962 as a sleeping pill and cure for morning sickness.
The company who produced the drug had under gone a small number of animal trials, but insufficient human testing. However due to the lack of regulations in some countries the drug was released. 1000s of birth defects arose as a result.
