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pharmacology 2 Flashcards

1
Q

what is the importance of clinical trials

A

they provide evidence for evaluation and sign guidelines

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2
Q

examples of drug treatment that is based on trial evidence

A

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

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3
Q

factors to consider when making a drug

A

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

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4
Q

reasons for conducting clinical trials

A

what works in theory might not work best in practise

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5
Q

what body regulates clinical trials

A

MHRA

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6
Q

what is tested when checking on clinical trials

A

safety
efficacy

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7
Q

aspects of efficacy that are tested on

A

compared with placebo
compared with another drug

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8
Q

stages in the development of a drug

A

drug discovery
preclinical development
clinical development
tegenero drug

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9
Q

phase 1 clinical development

A

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

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10
Q

phase 2 of drug development

A

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

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11
Q

how many people are involved in phase 2 clinical development

A

upto 500 patients

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12
Q

phase 3 clinical development

A

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

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13
Q

how many people involved in phase 3 clinical development

A

upto 10000 patients

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14
Q

phase 4 clinical development

A

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

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15
Q

examples of clinical trials

A

double blind
single blind
prospective
retrospective

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16
Q

factors to be considered during pre clinical development

A

animal pharmacology
animal toxicology
tissue culture

17
Q

factors under animal pharmacology

A

dose
adverse effects

18
Q

factors under toxicology

A

fertility
teratogenicity ‘
mutagenicity

19
Q

drugs that bypass phase 1 clinical development

A

. cytotoxics will bypass this phase

example chemotherapy

20
Q

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

A

pharmacokinetics and pharmacodynamics

21
Q

factors being considered in phase 2 clinical trials

A

evidence of efficacy
likely dosage range

22
Q

phase 4

A

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

23
Q

methods of controlled study

A

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.

24
Q

disadvantages of control trial

A

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

25
Q

what are the commonly used phase 3 designs

A

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

26
Q

superiority trials

A

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

27
Q

non-inferiority

A

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

28
Q

how to design a study

A

hypothesis
endpoints
number of subjects
safety endpoints

29
Q

exclusion and selection criteria

A

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

30
Q

challenges in conducting studies

A

declining renal function
multiple morbidities

31
Q

analysis of a study

A

p of 0.05 is usually taken as significance
choose statistical test

32
Q

interpreting an insignificant study

A
33
Q

what is a significance of a test

A

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

34
Q

interpreting an insignificant finding

A

No difference or just that the study hasn’t found one?

Two treatments may be clinically equivalent

35
Q

ethical factors to consider when conducting a study

A

Consent
Ethics committee
Placebos
Children
Study design
‘Policing’ studies

36
Q

what are the aims of a good clinical trial

A

Protect the public
Provide evidence to help rational prescribing

37
Q
A

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