AQA · GCSE · Biology
Course version: 8461 · Version from Sept 2018
New medical drugs have to be tested and trialled before being used to…
Full specification wording
Discovery and development of drugs: New medical drugs have to be tested and trialled before being used to check that they are safe and effective.
Before a new medicine can be prescribed, it must pass through testing and clinical trials.
Checked against the AQA 8461 specification (opens in a new tab) on .
- Point 5 of 9
- 3 key terms
Study notes
From the checked teaching notes for this specification point.
The idea
Before a new medicine can be prescribed, it must pass through testing and clinical trials. Testing checks two main things: safety, meaning the drug does not cause unacceptable harm, and efficacy, meaning it actually treats the condition. Preclinical laboratory work uses cells, tissues and live animals to look for toxicity and biological activity. If results are promising, clinical trials then involve healthy volunteers and patients. Trials are often randomised, controlled and sometimes blinded so that results are reliable. The drug is compared with a placebo or existing treatment, and data are analysed before a licence is granted. Without this evidence, doctors cannot know whether a drug will help more than it harms.
What earns the marks
- State that new drugs are tested and trialled before use to check safety and effectiveness.
- Describe preclinical testing using cells, tissues and live animals to assess toxicity and activity.
- Describe clinical trials involving healthy volunteers and patients, often comparing the drug with a placebo or existing treatment.
- Explain why trials are controlled, randomised or blinded to produce valid and reliable results.
- Link the purpose of testing to protecting patients from harm and confirming that the drug works.
Common mistakes and how to put them right
Thinking that a drug only needs to be tested for safety.
Put it right by stating that efficacy must also be checked.
Confusing preclinical testing with clinical trials.
Put it right: Preclinical work uses cells, tissues and animals, while clinical trials involve human volunteers and patients.
Assuming that a successful laboratory result means the drug is ready for patients.
Put it right by explaining that clinical trials and licensing are still required.
Exam tips
- Define safety and efficacy in your answer rather than repeating the words without explanation.
- Sequence your answer: preclinical testing first, then clinical trials, then licensing or approval.
- Mention at least one feature of fair testing, such as a control group, placebo or blinding, and say what it controls for.
Try the lesson
The start of the Discovery and development of drugs: New medical drugs have to be tested and trialled before being used to check that they are safe and effective. lesson, made from checked teaching notes for this specification point.
Have a go first
Why must all new medical drugs be tested and trialled before they are given to patients?
Listen
Before a new medicine can be prescribed, it must pass through testing and clinical trials. Testing checks two main things: safety, meaning the drug does not cause unacceptable harm, and efficacy, meaning it actually treats the condition. Preclinical laboratory work uses cells, tissues and live animals to look for toxicity and biological activity. If results are promising, clinical trials then involve healthy volunteers and patients. Trials are often randomised, controlled and sometimes blinded so that results are reliable. The drug is compared with a placebo or existing treatment, and data are analysed before a licence is granted. Without this evidence, doctors cannot know whether a drug will help more than it harms. A strong answer earns marks for these points. State that new drugs are tested and trialled before use to check safety and effectiveness. Describe preclinical testing using cells, tissues and live animals to assess toxicity and activity. Describe clinical trials involving healthy volunteers and patients, often comparing the drug with a placebo or existing treatment. Explain why trials are controlled, randomised or blinded to produce valid and reliable results. A common slip: Thinking that a drug only needs to be tested for safety. Instead, stating that efficacy must also be checked. Exam tip: Define safety and efficacy in your answer rather than repeating the words without explanation.
See it
Key words
Say what each word means before you turn the card.
Safety and efficacy
Try answering aloud or in your head before turning the card.
Preclinical testing
Try answering aloud or in your head before turning the card.
Clinical trials
Try answering aloud or in your head before turning the card.
See every definition
- Safety and efficacy
- Testing checks that a drug does not cause unacceptable harm and that it actually treats the condition.
- Preclinical testing
- Laboratory work using cells, tissues and live animals to look for toxicity and biological activity.
- Clinical trials
- Testing involving healthy volunteers and patients, often comparing the drug with a placebo or existing treatment.
Label the diagram
Some boxes have lost their names. Pick the right name for each number.
1Box 1
2Box 2
3Box 3
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