intro to clinical trials Flashcards
during clinical trials you always need to…
compare with a control group
what can you assess through clinical trials
devices, biomarkers, diagnostic tests, screening programmes
what are clinical trials
specific experimental ways of testing a clinical question
differences in outcomes between treatment groups may be due too
treatment effect
bias
chance
the best way to create a control group similar to the treatment group is too…
randmise all aspects
what are randomised clinical trials
therapies are allocated by a chance mechanism
what are the advantages of randomised control trials
- eliminates selection bias
- balance prognostic factors
- validity of statistical tests
what is a controlled clinical trials
prospective study comparing effects and value of intervention against a control of Human subjects
what are randomised clinical trials
controlled trials where therapies are allocated by a chance mechanism
what is an uncontrolled clinical trial
involves no control group
which is the best design that reduces bias
randomised control
randomisation reduces what type of bias
selection and allocation bias
what is a placebo
a control group receives on inactive substance that looks like the drug or treatment being tested
blind trials strengthen what…
randomisation
what is a single blind trial
patient does not know if they are in experimental or control group
what is a double blind trial
patient and clinical does not know the experimental or control group
a placebo must be
identical to the active drug in taste, appearance and texture
what is non-compliance
when not every participant remains in the trial or when not every patient complies with their allocated treatment
to understand if the new treatment is better than the standard treatment there are two things we need to address…
1- Is the physiological action of the new treatment better than the standard.
2. IS the new treatment better than the standard treatment in routine practise
what are explanatory trials
analyses only those who completed follow-up and complied with treatment
what is a negative of an explanatory trial
loses randomisation
explanatory trials are also called
as-treated analysis
pragmatic trials are also called
intention to treat
which type of trial gives a larger sample size
as-treated
which type of trial reflect effects in clinical practise
intention to treat
what is clinical equipoise
reasonable uncertainty that the person assigning people to groups does not know which treatment is better thus randomisation does not deny the patient the best treatment
