drug testing- lqc 4

Question 1

historic drug testing- william withering’s protocol

Answer 1

• Potentially useful plant chemical/substance identified
• Trial on small group of patients with the disease – side effects recorded
• Trial on larger group of patients to discover the most effective dose
• Results recorded and published – general use

Question 2

pre clinical trials

Answer 2

Lab testing on animals or cells /tissue cultures – to assess safety /side effects and determine if drug is effective against disease.

Question 3

clinical trials phase 1

Answer 3

Small group of healthy human volunteers are given the drug to look for side effects in humans. Different doses are trialled to find one which is both safe and effective. Is the drug absorbed, distributed, metabolised, excreted as expected?

Question 4

clinical trials phase 2

Answer 4

Does the drug work? The drug is tested on a small group (100-300) of volunteer human patients who have the disease.

Question 5

clinical trials phase 3

Answer 5

A double-blind randomised controlled trial
A larger group (1000-3000) of patients are assigned randomly to either a test group, who are given the new drug or a control group, who are given the existing drug (or a placebo/sugar pill if no existing drug is available). Checks for effectiveness (efficacy) and side effects.
Control group for comparison with the test group, to prove that any improvement is due to the new drug – improves validity
Statistical analysis of data - checks if drug is effective by seeing if there is a significant difference/improvement in patients taking it compared to those taking the existing drug

Question 6

after licensing

Answer 6

Drug licenced. Data on efficacy and safety continues to be collected/monitored.

Question 7

what is placebo

Answer 7

• An inactive substance which does not contain the drug
• Used as a control to compare to the actual drug
• It removes the psychological effect taking a drug

Question 8

what is a double- blind trial

Answer 8

· Some people are given the drug and some are given a placebo (or existing drug)
· Neither the doctor nor the patient know who has been given the actual drug and who has been given the placebo
· This removes bias from the trial