8 3 William Withering tested his digitalis ‘soup’ by an early form of drug testing. Withering reported that his first patient found that the digitalis “made him very sick, the sickness recurring at intervals for several days.” Modern drug testing protocols include four stages. (a) (i) In modern drug testing protocols, the first stage that patients with an illness are involved is (1) A preclinical trials B phase 1 C phase 2 D phase 3 (ii) In modern drug testing protocols, side effects such as nausea will first be identified in healthy volunteers during (1) A preclinical trials B phase 1 C phase 2 D phase 3 Turn over 9 (b) Modern drug testing protocols must ensure that new drugs are effective at treating patients. Explain the role that a placebo and a double blind trial have in producing valid conclusions. (4) Placebo .................................................................................................................................................................................................................................................................................... .................................................................................................................................................................................................................................................................................... .................................................................................................................................................................................................................................................................................... .................................................................................................................................................................................................................................................................................... .................................................................................................................................................................................................................................................................................... .................................................................................................................................................................................................................................................................................... Double blind trial .................................................................................................................................................................................................................................................................................... .................................................................................................................................................................................................................................................................................... .................................................................................................................................................................................................................................................................................... .................................................................................................................................................................................................................................................................................... .................................................................................................................................................................................................................................................................................... .................................................................................................................................................................................................................................................................................... 10 (c) Drug trials may last 15 years before the drug is licensed. The results of each stage are analysed before the drug trial can progress. The results of a trial of a drug for lowering blood pressure are shown in the table. Mean reduction in blood pressure / mmHg People given the drug People given a placebo 7 ± 12 4 ± 8 Testing of this drug did not proceed beyond this stage. Deduce why the drug trial was stopped at this stage. (3) .................................................................................................................................................................................................................................................................................... .................................................................................................................................................................................................................................................................................... .................................................................................................................................................................................................................................................................................... .................................................................................................................................................................................................................................................................................... .................................................................................................................................................................................................................................................................................... .................................................................................................................................................................................................................................................................................... .................................................................................................................................................................................................................................................................................... .................................................................................................................................................................................................................................................................................... .................................................................................................................................................................................................................................................................................... (Total for Question 3 = 9 marks) Turn over 11 BLANK PAGE