Drug testing

Question 1

William Withering’s drug trial protocol

Answer 1

1. drugs tested on patients with symptoms of disease
2. side effects recorded
3. standard procedure used to discover effective dosage (slowly increase dose until patient experiences diarrhoea and vomiting then slightly reduce it - most effective dose)
4. recorded all the results and published them

Question 2

what are the 5 stages of the contemporary drug testing protocol

Answer 2

pre-clinical trials
clinical trials - phase 1
clinical trails - phase 2
clinical trails - phase 3
after licensing

Question 3

what occurs in the pre-clinical trials of drug testing

Answer 3

lab testing on animals or cells/tissue cultures
done to assess symptoms or side affects and if drug is effective against disease

Question 4

what occurs in the clinical trials - phase 1

Answer 4

small group of healthy human volunteers given drug to look for side affects
different doses are trialled the find which one is safest and most effective
need to see if drug is absorbed, distributed and excreted in the way it is expected

Question 5

what occurs in the clinical trials - phase 2

Answer 5

drug is tested on a small group of volunteer human patients who have disease (100-300)

Question 6

what occurs in the clinical trials - phase 3

Answer 6

double-blind randomised control trail
larger group of around 1000-3000 patients are assigned to either a test group who are given the new drug or a control group who are given a placebo
this checks for effectiveness and side affects
control group for comparison with the test group to prove any improvement is due to new drug (improves validity)
statistical analysis of data which checks if drug is effective by seeing if there is a significant improvement in patients taking it compared to an existing drug

Question 7

what occurs in after licencing

Answer 7

drug is licensed
data on effectiveness and safety continues to be collected and monitored

Question 8

why is the contemporary drug testing protocol safer

Answer 8

serious side affects are picked up in pre-clinical trails (animals)
use of specific active ingredient allows a precise dose to be given

Question 9

why is the contemporary drug testing protocol more reliable

Answer 9

larger sample sizes removes effects due to chance
random assignment of patients removes bias
double-blind trial removes bias from researcher and doctors prescribing the drug
statistical analysis help distinguish effective drugs and doses

Question 10

why is the drug tested on healthy individuals in clinical trial phase 1

Answer 10

check there are no unexpected side affects
to establish absorption, distribution and excretion rates of drug

Question 11

what is a double blind trail and why is it used

Answer 11

what is it:
some people given new drug and some people not given new drug
use placebo (inactive drug or sugar coated dummy pill)
doctors and patients do not know who is on what drug
why it is used:
to see if drug works better than placebo
reduces bias