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Unit 1 - Clinical Trial
Athletes are routinely drug tested by taking samples of blood.

Unit 1 - Clinical Trial

This GCSE Biology quiz explores how new drugs are tested, from early safety checks to clinical trials on volunteers, and why careful testing protects patients.

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(quiz starts below)

Fascinating Fact:

Before clinical trials, new drugs are tested in the laboratory on cells, tissues, and animals to check for toxicity, effectiveness, and best dose.

In GCSE Biology, you learn that clinical trials are carefully controlled tests on human volunteers and patients. They compare a new medicine with a control to check safety, effectiveness, suitable doses, and possible side effects before wider use.

  • Clinical trial: A controlled study that tests a new drug on people to check its safety and how well it works.
  • Placebo: A dummy treatment with no active drug, used so results can be fairly compared with the real medicine.
  • Double-blind trial: A trial in which neither the doctor nor the volunteer knows who receives the real drug or the placebo until the end.
What is a clinical trial in GCSE Biology?

In GCSE Biology, a clinical trial is a test of a new medicine on human volunteers or patients, designed to check that it is safe and that it treats the illness effectively.

Why are placebos used in clinical trials?

Placebos are used so that researchers can compare the effects of the real drug with a treatment that has no active ingredient, helping them see whether improvements are due to the medicine itself.

Why are some clinical trials double-blind?

Clinical trials are often double-blind so neither doctors nor volunteers know who has the real drug, which reduces bias and makes the results more reliable and scientifically fair.

1 .
In a double blind trial, who is allowed to know if the patient has taken the drug?
Both patients and doctors
Neither patients or doctors
Patients know but doctors do not
Only the doctors know
If the patient and doctors know they are being treated with the drug, this may influence their perception of the effects of the drug
2 .
Which of the following is a reason that patients must stop taking a prescribed drug?
If the benefits outweigh the side effects
If the drug has been shown not to work
If no toxicity is observed
If the optimum dose is achieved
With current laws, it is unlikely that a drug would ever reach the market unless it is shown to be effective
3 .
During a clinical trial, variables need to be controlled including age, state of health and what else?
Gender
Temperature
Hair colour
pH
It is possible that a drug could affect women differently to men
4 .
Before clinical trials, which of the following are new drugs not tested on for toxicity?
Cells
Humans
Tissues
Animals
It is a legal requirement for drugs to be tested on animals for toxicity
5 .
Statins are drugs which lower the blood concentration of what?
Cholesterol
Amino acids
Glucose
Insulin
High cholesterol is linked to heart disease. Eating a diet that is not balanced can increase the risk of suffering from high cholesterol levels. Some scientists have found that exercise can help to balance cholesterol levels in the blood but more research is needed
6 .
The drug thalidomide was banned because it caused which side effect?
Heart problems
Kidney disease
Limb deformities
Deafness
Other effects included deformed eyes, hearts, alimentary and urinary tracts, blindness and deafness. It was withdrawn from sale but not until at least 10,000 people around the world had been affected
7 .
A sample of what is taken when athletes are routinely drug tested?
A sample of hair
A sample of blood
A sample of faeces
A sample of muscle
Drug testing may be carried out on blood or urine samples
8 .
New drugs are all tested for efficacy, toxicity, dosage and what else?
Safety
Variables
Placebo
Double blind
New drugs are first tested for safety using computer models and then on non-human animals. Volunteers in clinical trials are carefully monitored just in case it proves to be unsafe for humans despite the previous research
9 .
What does a placebo consist of?
A drug
No drug
Salt
Water
A placebo must resemble the drug being tested so that clinical trial volunteers don't guess that they are not taking the real thing
10 .
Which word describes the effectiveness of a drug?
Its efficacy
Its ethics
Its dose
Its authority
Clinical trials are also used to determine the minimum dose needed for the drug to be effective
You can find more about this topic by visiting BBC Bitesize - Treating, curing and preventing disease

Author:  Donna Davidson (GCSE Biology Teacher & Examiner, Quiz Writer)

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