pharmacology 2 Flashcards
what is the importance of clinical trials
they provide evidence for evaluation and sign guidelines
examples of drug treatment that is based on trial evidence
treatment for myocardial infarction
treatment for stroke
treatment for cancer
treatment for rheumatoid arthritis
factors to consider when making a drug
whether it works
the dose that is therapeutic
toxic dose
safe dose
whether or not it is necessary
reasons for conducting clinical trials
what works in theory might not work best in practise
what body regulates clinical trials
MHRA
what is tested when checking on clinical trials
safety
efficacy
aspects of efficacy that are tested on
compared with placebo
compared with another drug
stages in the development of a drug
drug discovery
preclinical development
clinical development
tegenero drug
phase 1 clinical development
volunteer are given the drug and there is also some that are given on a placebo effect
phase 2 of drug development
this occurs after the the volunteers have been found to be healthy , and it is given to confirm the kinetics and dynamics in patients.
how many people are involved in phase 2 clinical development
upto 500 patients
phase 3 clinical development
formal therapeutic trials where effective and they are established and the evidence of safety is obtained.
how many people involved in phase 3 clinical development
upto 10000 patients
phase 4 clinical development
includes post marketing surveillance which produces evidence of long term safety .
involves tens or hundreds patients
examples of clinical trials
double blind
single blind
prospective
retrospective
factors to be considered during pre clinical development
animal pharmacology
animal toxicology
tissue culture
factors under animal pharmacology
dose
adverse effects
factors under toxicology
fertility
teratogenicity ‘
mutagenicity
drugs that bypass phase 1 clinical development
. cytotoxics will bypass this phase
example chemotherapy
what are the factors being tested on in phase 11 clinical development
pharmacokinetics and pharmacodynamics
factors being considered in phase 2 clinical trials
evidence of efficacy
likely dosage range
phase 4
-post marketing surveillance to produce evidence of long term safety
-may involve tens or hundreds of patients .
methods of controlled study
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.
disadvantages of control trial
generalizable results
recruitment
acceptability of randomization process
administrative complexity of randomised methods
what are the commonly used phase 3 designs
Parallel
Withdrawal
Group/Cluster
Randomized Consent
Cross Over
Factorial
Large Simple
Equivalence/Non-inferiority
Sequential
superiority trials
Show that new treatment is better than the control or standard (maybe a placebo)
non-inferiority
Is not worse that the standard by more than some margin
Would have beaten placebo if a placebo arm had been included (regulatory)
how to design a study
hypothesis
endpoints
number of subjects
safety endpoints
exclusion and selection criteria
Exclude pregnant women
Children
Seriously ill patients
? Elderly patients
Patients at risk of side effects
challenges in conducting studies
declining renal function
multiple morbidities
analysis of a study
p of 0.05 is usually taken as significance
choose statistical test
interpreting an insignificant study
what is a significance of a test
whether or not they were by chance or there is an association
interpreting an insignificant finding
No difference or just that the study hasn’t found one?
Two treatments may be clinically equivalent
ethical factors to consider when conducting a study
Consent
Ethics committee
Placebos
Children
Study design
‘Policing’ studies
what are the aims of a good clinical trial
Protect the public
Provide evidence to help rational prescribing
