exam questions

• Describe how scientists, after testing the salve on mice, could test whether the drug is an appropriate treatment for humans (4)

  -       Drug given to health humans 

  -       Double blind trial- treat one group of patients with drug and another with existing treatment 

  -       Neither doctor nor patient know which treatment is being used 

  -       Participants monitored for side effects

  -       Compare the outcomes of patient’s treatment with the salve and control group 
• Explain why healthy volunteers are given different doses of drug or a placebo (2) 

  -       Check for side effects 

  -       Different doses to determine a safe dose 

  -       Placebo to make sure that any side effects describe were due to the drug
• Compare and contrast this drug testing protocol with that used by William withering when he tested digitalis soup (3)

  -       Both trials used different doses to determine safe dosage 

  -       William withering did not use healthy volunteers and this drug trial did 

  -       William withering did not use a placebo while this trial did
• Describe how clinical trials of a vaccine would be conducted (3) 

  -       Small group of healthy volunteers are given the vaccine to test for side effects 

  -       Healthy volunteers tested for presence of antibodies to the virus following vaccination 

  -       A group of people at risk of contracting the disease is given the vaccine 

  -       The number of people who develop the viral disease following vaccination are monitored
• In modern drug testing protocols, the first stage that patients with an illness are involved in is (1)

  -       Phase 2
• Explain the role that a placebo and a double bind trial have in producing valid conclusions (4) 

  Placebo 

  -       Provides a control group for comparison 

  -       Therefore, ensuring the active ingredient is causing the effect 

  Double bind trial 

  -       Because neither doctors nor patients know who has been given the actual drug 

  -       Therefore, ensures that bias is removed from the trial
• Explain the purpose of each stage of protocol when developing drug (3) 

  Phase 1= to make sure drug is not harmful 

  Phase 2=to see if it is effective in treating the condition 

  Phase 3= to gather data to look for rare side-effects       Double bind trials 

  In phase 1 and 2 to test for side effects
• Describe how the safe dose of a cancer drug could be determined (3) 

  -       Test the drug on healthy individuals/animals/cell cultures 

  -       Then test on group of individuals with cancer 

  -       Gradually increasing the dose to determine dose that does not cause side effects 
• Explain 4 reasons why a contemporary drug testing protocol is an improvement on the trial used by William withering (4)

  -       Safer due to pretesting on cells/animals before and pure drug used rather than extract 

  -       More valid- placebo used as a comparison, involves double blind trials 

  -       More reliable- more people are tested, results analysed statistically
• Describe how double-blind trial can be carried out (4) 

  -       With a large group of people with illness 

  -       Of similar age/gender/lifestyle 

  -       Divided into 2 groups, one given the new drug and other given alternative treatment or placebo (inactive substance)

  -       Neither the patients nor doctor know who is in which group