AQA GCSE Combined Science: Trilogy Biology Paper 1 (Foundation), 2020: Question 2
11 marks · Standard Demand difficulty · Short Answer
Interpret a drug trial on children with high body temperature, including a placebo comparison and the effect of paracetamol over time.
Practise this questionQuestion
Question text
02 New drugs are tested before they can be licensed for use with patients.
Figure 2 shows how much time the different stages of testing took for one new drug.
Figure 2
02.1 Preclinical testing is done in a laboratory.
What is the drug tested on in a laboratory?
Give one example.
[1 mark]
02.2 How many years did the clinical trials take for the drug in Figure 2?
[1 mark]
Time for clinical trials = years
02.3 During Phase 1 clinical trials, the drug is tested on healthy volunteers using
low doses.
What is the main purpose of Phase 1 testing?
*06* [1 mark]
Tick ( ) one box.
To find the best dose to use.
To see if the drug is safe to use.
To see if the drug works.
During clinical trials, half of the patients are given a placebo in a double blind trial.
02.4 What is a placebo?
[1 mark]
02.5 Who knows which patients are given the placebo and which patients are given the
drug in a double blind trial?
[1 mark]
Tick ( ) one box.
Not the patients or the doctors
The patients and the doctors
The patients but not the doctors 8
Paracetamol and ibuprofen are two medicines used to reduce a high
body temperature.
Doctors investigated which medicine was more effective at reducing high body
temperature in 200 children who were ill.
*07* The children were put into two groups, which were matched for:
• age
• gender
• body mass.
Each group had 100 children.
This is the method used.
1. Measure the body temperature of each child before any medicine is given.
2. Give children in Group 1 paracetamol.
3. Give children in Group 2 ibuprofen.
4. Measure the body temperature of each child every hour after the medicine is given.
02.6 Give two control variables in this investigation.
[2 marks]
02.7 None of the children was given a placebo.
Suggest one reason why.
[1 mark]
Figure 3 shows the results.
Figure 3
02.8 What was the mean body temperature after 6 hours for the children given ibuprofen?
[1 mark]
Mean body temperature = °C
02.9 The doctors concluded that children with a high body temperature should be
given ibuprofen and not paracetamol.
*09* Give two reasons for the doctors’ conclusion.
Use Figure 3.
[2 marks]
Mark scheme
Show the mark scheme
AO /
Question Answers Extra information Mark
Spec. Ref.
02.1 any one from: 1 AO1
• (live) cells 4.3.1.9
• (live) tissues
• (live) animals allow examples , eg mice / rats
02.2 7 / seven (years) 1 AO2
4.3.1.9
02.3 to see if the drug is safe to use 1 AO2
4.3.1.9
02.4 tablet that does not contain the allow a sugar pill 1 AO1
drug / active ingredient allow a fake drug 4.3.1.9
02.5 not the patients or the doctors 1 AO1
4.3.1.9
02.6 any two from: 2 AO2
• age 4.3.1.9
• gender
• body mass
• number of children (in group)
or
100 in group
• time (after taking medicine)
when temperature was
measured
allow all (children had a) high
body temperature (at the start)
allow dose of drug / medicine
ignore temperature unqualified
02.7 any one from: 1 AO3
• unethical not to treat ill 4.3.1.9
10 children
• children were ill so had to be
treated
• children may become more ill
if no drug given
02.8 37.4 (°C) 1 AO2
4.3.1.9
02.9 allow converse arguments AO3
any two from: 2 4.3.1.9
• reduced (body) temperature
faster
• decreased (body) temperature
more
• reduced (body) temperature allow paracetamol did not
to normal / 37 °C reduce (body) temperature to
normal
• maintained normal (body)
temperature / 37 °C for longer
or for several hours
Total 11
How to answer it
Drug Testing and Comparing Fever Medicines
What this question tests
This question tests your knowledge of how new drugs are tested, why clinical trials are done in stages, what a placebo and double-blind trial are, how to identify control variables in an investigation, and how to read graphs to compare the effect of two medicines on body temperature.
💡 Key knowledge
- New drugs are tested first in the lab, then on healthy volunteers, then on patients.
- Preclinical testing uses cells, tissues or live animals.
- Clinical trials test safety, dosage and effectiveness.
- A placebo does not contain the active drug.
- In a double-blind trial, neither the patients nor the doctors know who gets the real drug.
- When comparing medicines, only one variable should change.
- Graph questions often reward careful reading of values and direct comparisons.
🧠 Exam technique
- For 1-mark questions, give one precise statement only.
- Use wording close to the mark scheme where possible: safe to use , does not contain the active ingredient , neither doctors nor patients know .
- On graph questions, quote data if you can.
- For “give two variables” questions, choose things that are clearly controlled in both groups.
Part (a) / 02.1
Preclinical testing in the laboratory
✅ Correct answer
Any one of:
- live cells
- live tissues
- live animals
💡 Key knowledge
Before testing drugs on humans, scientists do preclinical testing to look for toxicity, efficacy and the best dose.
❌ Common errors
- Saying “humans” — that is clinical testing, not preclinical.
- Giving equipment instead of what is being tested on.
Part (b) / 02.2
Time from idea to the drug in Figure 2
✅ Correct answer
7 years
📐 How to read it
- Look at the bar for the drug in Figure 2.
- Read the start time and end time from the x-axis.
- Calculate duration = end − start.
- The total is 7 years.
❌ Common errors
- Giving the finishing year instead of the length of time.
- Miscounting the intervals on the axis.
Part (c) / 02.3
Why Phase 1 clinical trials use healthy adults on low doses
✅ Correct answer
To see if the drug is safe to use.
💡 Key knowledge
Phase 1 trials are mainly about safety. Low doses reduce risk while scientists watch for side effects.
🧠 Exam technique
If the question asks why healthy adults are used first, the safest exam wording is about safety, not cure or effectiveness.
Part (d) / 02.4
What is a placebo?
✅ Correct answer
A tablet that does not contain the drug / active ingredient.
💡 Key knowledge
A placebo is used for comparison so scientists can see whether the real drug actually works better than no active treatment.
❌ Common errors
- Saying “a weaker drug” — a placebo has no active ingredient.
- Saying “a control variable” — placebo is part of the trial design, not a variable.
Part (e) / 02.5
Who does not know who got the medicine in a double-blind trial?
✅ Correct answer
Not the patients or the doctors.
🧠 Exam technique
For double-blind, learn the exact phrase: neither the patients nor the doctors know.
💡 Key knowledge
This reduces bias when results are recorded and judged.
Part (f) / 02.6
Control variables in the investigation
✅ Correct answers
Any two from:
- age
- gender
- body mass
- number of children in each group / 100 in each group
- time after taking medicine when temperature was measured
💡 Key knowledge
A control variable is something kept the same so the comparison is fair.
The mark scheme also allows similar ideas such as all children starting with a high body temperature, or dose of medicine.
But “temperature” on its own is too vague and would not be credited.
🧠 Exam technique
Pick variables that are clearly stated in the method. This is safer than inventing your own.
Strong exam answers here are short and specific, for example:
- Age of children
- Time after taking the medicine when temperature was measured
❌ Common errors
- Writing the independent variable, such as type of medicine.
- Writing “temperature” without saying starting temperature or time temperature was measured.
- Giving just one variable when two are needed.
Part (g) / 02.7
Why there was no placebo group
✅ Correct answer
Any one from:
- It would be unethical not to treat ill children.
- The children were ill so had to be treated.
- Children may become more ill if no drug is given.
💡 Key knowledge
Ethics matter in clinical trials. If patients are sick, leaving them untreated can be unsafe and unfair.
🧠 Exam technique
Use the word unethical when appropriate — examiners like precise scientific vocabulary.
Part (h) / 02.8
Normal body temperature from Figure 3
✅ Correct answer
37.4 °C
📐 Reading the graph
- Find the horizontal line labelled as normal body temperature.
- Read its value from the y-axis.
- The value is 37.4 °C.
❌ Common errors
- Writing 37 °C from memory instead of reading the graph.
- Missing the decimal place.
Part (i) / 02.9
Why doctors concluded ibuprofen was better than paracetamol
✅ Correct answers
Any two from:
- Ibuprofen reduced body temperature faster.
- Ibuprofen decreased body temperature more.
- Ibuprofen reduced body temperature to normal / 37 °C.
- Ibuprofen maintained normal body temperature / 37 °C for longer or for several hours.
💡 Key knowledge
This is an AO3 graph interpretation question. You must compare the two lines, not just describe one line.
Top answers use comparative language such as faster, more, to normal temperature, and for longer.
🧠 Exam technique
A strong 2-mark answer could be:
- Ibuprofen lowered the children’s temperature faster.
- It brought temperature down to normal and kept it there for longer.
This scores well because it gives two clear comparisons.
❌ Common errors
- Saying only “ibuprofen worked better” with no evidence.
- Describing one line without comparing it to the other medicine.
- Using vague phrases like “it was lower” without saying faster, more, or to normal.
💡 Where students gained marks
- Using exact trial vocabulary: placebo, double-blind, safe, control variable.
- Reading graph values carefully instead of using remembered “facts” like 37 °C.
- Making direct comparisons in the final graph question.
❌ Where students lost marks
- Mixing up preclinical and clinical testing.
- Giving vague control variables.
- Not mentioning ethics for the placebo question.
- Forgetting that the question asks for why doctors concluded, so evidence from the graph is needed.
🧠 Full-mark strategy
- For 1-mark items: be short and exact.
- For 2-mark compare questions: make two separate comparison points.
- Always read the graph given, even if you think you know the science already.
Quick full-mark answers
- 02.1: live cells
- 02.2: 7 years
- 02.3: to see if the drug is safe to use
- 02.4: a tablet that does not contain the active ingredient
- 02.5: not the patients or the doctors
- 02.6: age; body mass
- 02.7: it would be unethical not to treat ill children
- 02.8: 37.4 °C
- 02.9: ibuprofen reduced temperature faster and brought it to normal for longer
Topics
Biology · B3: Infection and Response
Question and mark scheme from the AQA GCSE Combined Science: Trilogy examination, Biology Paper 1 (Foundation), 2020. QuestionVault is an independent revision resource; questions remain the copyright of the awarding body.