Biology Case Study

Laboratory Tests

The disease needs to be studied and must be understood on how it makes people ill. This helps to understand what would be needed to treat it. Example in cancer there is a fault in the cells, so to treat cancer you would destroy the faulty cells.

The scientists search for natural ways of making the treatment as it may have similarities to the disease or because it can simply kill the disease. Example for cancer you would use radiation to rid of the cancerous cells by killing them. 

When there is a chemical that may be suitable. Many many tests are done on it. There must also be enough of the chemical or a lot of the people needing this treatment will suffer. There mustn’t be any problems found with the drugs in this stage or it will be impossible for the drug to go into the second stage.

Phase 1 of stage 1 is testing on human cells. Tests are done on human cells in a lab. Scientist would see the effects of different doses of the potential drug. They test it on different types of body cells with the disease. The whole point of this test is to see how well the chemical works against the disease and how effective it is. From here the scientist have a rough idea on how safe the drug is for the cells.

Phase 2 is similar to Phase 1. The only difference is that phase 2 is tested on animals (mostly rodents). These trials are carried out to make sure they work on a whole animal rather than cells grown in the lab.

Human testing

Perfectly healthy volunteers are selected to test the drug for safety, if this doesn’t happen there could be a chance of dangerous side effects on the other patients. After been tested on health humans they test them on the ones with illnesses. So this stage gives more data about the effectiveness and safety of the drug.

 New Molecular Entities are compounds which emerge from the process of drug discovery. These will have promising activity against a particular biological target thought to be important in disease; however, little will be known about the safety and toxicity of the NME in humans. The scientists behind the development of the drug have to assess the safety of the drug before putting it forward into clinical trials. Another thing the drug developers should do is to make a recommended dose for the patients or there could be catastrophic incidents.

The drug is now ready to be tested on human body cells. Most of these will be done in side a test tube or Petri dish. The drug and the human cell will be put together to see the effect of the drug, whether it will stop the disease from spreading and kill it or whether it will simply make it worse. This test will be carried out many times and until t works the variables will keep changing until a positive outcome.

If the drug doesn’t seem to work then the scientist will start all over again until it is successful. 

After the drug has been thoroughly analysed and successfully tested on human cells it will be tested on animals. When tested on animals most animals are euthanized, meaning they are killed after the drug is tested on them.  Animals are tested to see whether the drug works on full bodied animals as only testing it on a couple of human cells doesn’t really give us the scale on how it would react on a full human. But only testing on small animals such as rodents and frogs won’t let us know the full potential of the drug. Soon after testing on these smaller animals testing will be conducted on larger animals to see how their bodies react to the drug. If an animal reacts badly to the drug they will scrap the drug and try again from the very beginning. Soon the drug will be ready for release into the market. But before that there will be clinical trials.

Many animals are hurt and killed in the process of developing the drugs.

Clinical Trials are trials conducted to test safety data to be collected for health. These trials can only take place after thorough information has been collected on a quality that the country the trial is taking place can accept. Depending on the drug and the stage in its development, investigators will register healthy volunteers and patients with the illness the drug is meant to cure. The patients must approve of their name being added to the register or they have the legal obligation to refuse.

Clinical trials which involve new drugs are classified into four main phases. The first 3 phases will usually be approved by national regulatory authority for use in the general population but phase 4 will be after the approval studies.

Phase 1

Healthy volunteers will be selected, normally in groups of 20 to 100. This phase is to assess the safety of the drug.  The trials are often conducted in a hospital or an inpatient clinic where the volunteers can be observed by full time staff.

Patients in the control group receive small doses of the drug to see how the drug is processed within the body.

Another group will be given a single dose of the drug and tested to see if they would have any adverse side effects. The dose is made larger and given to another group for the same research.

A very small group will take a short trial to see how the drug will react by the body after eating.  Volunteers will be given two identical doses of the drug on different occasions. While being fasted and one after being fed.

Phase 2

Once the initial safety of the drug has been confirmed in phase 1, Phase 2 trials are performed on groups with 20 to 300 volunteers and are designed to assess how well the drug actually works and safety of the drug. Drugs tend to fail more often when in phase 2. This Phase of the clinical trial also sees the use of a placebo. Some patients will receive the drug while others will receive a placebo. Patients may or may not know that they are receiving the placebo. When a patient and the doctor both know who is taking the placebo it is known as an open trial. When only the doctor knows who has the placebo its known as a blind trial and when neither the doctor nor the patient know who’s on the placebo it’s called a double blind trial.

Sometimes both Phase 1 and Phase 2 are combined to test effectiveness and safety.

Phase 3

Phase 3 is when larger groups are tests and are aimed at being the group which will decide whether the drug can be released. The group will do all the same tests done in phase 2, but is decisive because there are many many more people taking part. Phase 3 is the most expensive, time consuming and difficult trials to run.

Phase 4

Phase 4 is also known as post marketing surveillance Trial. Phase 4 involves the safety surveillance and ongoing technical support of a drug after its legally available to the public. The surveillance is designed to detect any long term side effects and also whether it’s safe to be used by pregnant women.

After all these things are completed the drug is deemed safe and therefore safe to use.

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In conclusion I think drug trials should be allowed. Even though I have looked into the harmfulness of drug trials and how they may or may not be harmful. What i have learnt about drug trials during my research has made me think that these Clinical trials should be allowed as the benefits of them outweigh the risks.

The strongest answer for my question “Should Drug Trials be allowed?” is ‘Yes drug trials should be allowed because they help keep people alive and well. Without drug trials we would have no safe medicines, without any safe medicines we would all be ill, and eventually die.

Another factor as to why I decided that Drug trials should be allowed is that all the benefits outweigh the risks and that it’s saved millions and billions of lives.

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Twenty First Century Science GCSE Biology