New drugs are tested and trialled before they can be licensed to treat patients - AQA - GCSE Biology Combined Science - Question 6 - 2020 - Paper 1
Question 6
New drugs are tested and trialled before they can be licensed to treat patients. Figure 6 shows how much time the different stages of testing took for one new drug.
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Worked Solution & Example Answer:New drugs are tested and trialled before they can be licensed to treat patients - AQA - GCSE Biology Combined Science - Question 6 - 2020 - Paper 1
Step 1
How much more time did the clinical trials take compared with the preclinical testing?
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Answer
The clinical trials took 3 years more time compared with the preclinical testing.
Step 2
Suggest one reason why low doses of the drug are used in Phase 1 clinical trials.
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Answer
Lower doses are used to reduce any risk of harm to the healthy volunteers participating in the trial.
Step 3
Suggest two reasons why healthy volunteers are used in Phase 1 clinical trials.
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Healthy volunteers allow researchers to understand the effects of the drug without complications from pre-existing health conditions.
Healthy individuals are less likely to have adverse reactions that could confound the results.
Step 4
Suggest one reason why the results must be reviewed by other scientists.
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Peer review is necessary to ensure accuracy and reliability of the research findings before publication.
Step 5
Evaluate the decision to allow the use of drug C to treat AMD in the UK.
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The decision to allow drug C for AMD treatment should be evaluated on several grounds.
Arguments for use:
Drug C is significantly less expensive (£28) compared to drugs A (£561) and B (£800), making it a more feasible option for patients and the NHS.
It has the potential to treat a larger number of patients with AMD, considering its lower cost, thus addressing a larger public health need.
It could save the NHS money overall by allowing more widespread treatment without increasing costs excessively.
Arguments against use:
Drug C has not been tested specifically for AMD in the UK which raises concerns about its efficacy in treating this condition.
There is uncertainty regarding the side effects and the safety profile for AMD patients, as the drug has previously only been used in cancer treatment.
Prescribing untested drugs may set a precedent that could lead to further unregulated prescriptions, which is risky for patient safety.
Conclusion:
The decision seems reasonable given the potential benefits; however, further research and testing specifically on AMD patients might be essential before widespread use.