pharmacology 2

Question 1

what is the importance of clinical trials

Answer 1

they provide evidence for evaluation and sign guidelines

Question 2

examples of drug treatment that is based on trial evidence

Answer 2

treatment for myocardial infarction
treatment for stroke
treatment for cancer
treatment for rheumatoid arthritis

Question 3

factors to consider when making a drug

Answer 3

whether it works
the dose that is therapeutic
toxic dose
safe dose
whether or not it is necessary

Question 4

reasons for conducting clinical trials

Answer 4

what works in theory might not work best in practise

Question 5

what body regulates clinical trials

Answer 5

MHRA

Question 6

what is tested when checking on clinical trials

Answer 6

safety
efficacy

Question 7

aspects of efficacy that are tested on

Answer 7

compared with placebo
compared with another drug

Question 8

stages in the development of a drug

Answer 8

drug discovery
preclinical development
clinical development
tegenero drug

Question 9

phase 1 clinical development

Answer 9

volunteer are given the drug and there is also some that are given on a placebo effect

Question 10

phase 2 of drug development

Answer 10

this occurs after the the volunteers have been found to be healthy , and it is given to confirm the kinetics and dynamics in patients.

Question 11

how many people are involved in phase 2 clinical development

Answer 11

upto 500 patients

Question 12

phase 3 clinical development

Answer 12

formal therapeutic trials where effective and they are established and the evidence of safety is obtained.

Question 13

how many people involved in phase 3 clinical development

Answer 13

upto 10000 patients

Question 14

phase 4 clinical development

Answer 14

includes post marketing surveillance which produces evidence of long term safety .
involves tens or hundreds patients

Question 15

examples of clinical trials

Answer 15

double blind
single blind
prospective
retrospective

Question 16

factors to be considered during pre clinical development

Answer 16

animal pharmacology
animal toxicology
tissue culture

Question 17

factors under animal pharmacology

Answer 17

dose
adverse effects

Question 18

factors under toxicology

Answer 18

fertility
teratogenicity ‘
mutagenicity

Question 19

drugs that bypass phase 1 clinical development

Answer 19

. cytotoxics will bypass this phase

example chemotherapy

Question 20

what are the factors being tested on in phase 11 clinical development

Answer 20

pharmacokinetics and pharmacodynamics

Question 21

factors being considered in phase 2 clinical trials

Answer 21

evidence of efficacy
likely dosage range

Question 22

phase 4

Answer 22

-post marketing surveillance to produce evidence of long term safety
-may involve tens or hundreds of patients .

Question 23

methods of controlled study

Answer 23

placebo controlled study
comparison with other therapy
cross over design
randomised control clinical trial where the patients are assigned at random to either treatments or control.

Question 24

disadvantages of control trial

Answer 24

generalizable results
recruitment
acceptability of randomization process
administrative complexity of randomised methods

Question 25

what are the commonly used phase 3 designs

Answer 25

Parallel Withdrawal Group/Cluster Randomized Consent Cross Over Factorial Large Simple Equivalence/Non-inferiority Sequential

Question 26

superiority trials

Answer 26

Show that new treatment is better than the control or standard (maybe a placebo)

Question 27

non-inferiority

Answer 27

Is not worse that the standard by more than some margin Would have beaten placebo if a placebo arm had been included (regulatory)

Question 28

how to design a study

Answer 28

hypothesis endpoints number of subjects safety endpoints

Question 29

exclusion and selection criteria

Answer 29

Exclude pregnant women Children Seriously ill patients ? Elderly patients Patients at risk of side effects

Question 30

challenges in conducting studies

Answer 30

declining renal function multiple morbidities

Question 31

analysis of a study

Answer 31

p of 0.05 is usually taken as significance choose statistical test

Question 32

interpreting an insignificant study

Question 33

what is a significance of a test

Answer 33

whether or not they were by chance or there is an association

Question 34

interpreting an insignificant finding

Answer 34

No difference or just that the study hasn’t found one? Two treatments may be clinically equivalent

Question 35

ethical factors to consider when conducting a study

Answer 35

Consent Ethics committee Placebos Children Study design ‘Policing’ studies

Question 36

what are the aims of a good clinical trial

Answer 36

Protect the public Provide evidence to help rational prescribing