AQA · GCSE · Biology · Higher
Designing clinical trials for a treatment
The mAbs treatment for Candida albicans has been shown effective in the laboratory using infected tissue culture cells and infected live animals. It is now ready for clinical trials on people.
Describe how the clinical trials should be carried out.
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Marking points
- 1 Uses the official level descriptors and relevant clinical-trial steps to award 0-6 marks.
Full-mark answer
The treatment should first be given to healthy volunteers at a very low dose to check it is safe and to monitor side effects. It should then be tested on patients with Candida albicans to find the optimum dose and to see whether it works. A large double-blind trial should be used, with some patients receiving the mAbs and others receiving a placebo or alternative treatment, and variables should be controlled.