4 - drug testing

what is William Witherings drug testing protocol (4)

• a potentially useful plant chemical substance is identified,

• trial on a small group of patients with disease to see side effects,

• trial on a larger group to discover most effective dose,

• results are recorded and published for general use

what are the stages of contemporary drug testing protocol

• pre-clinical trials,

• clinical trials phase 1,

• clinical trials phase 2,

• clinical trials phase 3,

• after licensing

describe what’s involved in pre-clinical trials

lab testing on animals or tissue cultures are used to assess the safety/side effects and to determine if the drug is effective

describe what’s involved in clinical trial phase 1

small group of healthy human volunteers given drug to look for side effects and different doses are trialled to find one which is both effective and safe

describe what’s involved in clinical trial phase 2

drug is tested on a small group of volunteer human patients with the disease

describe what’s involved in clinical trial phase 3

a double bind randomised controlled trial is carried out to make comparisons with the control group so prove that any improvements are due to the new drug

describe a double bind randomised controlled trial

large group of patients are assigned randomly to a:

• test group - given new drug

• or control group - given existing drug or placebo,

what does a double bind randomised controlled trial allow

greater validity and statistical analysis of data to see if there’s a significant difference

describe what’s involved in after licensing

the drug is licensed and data of efficacy and safety are continued to be collected/monitored