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Flashcards in Clinical trials Deck (22):
1

Name 4 different trials

Double blind
Single blind
Prospective
Retrospective

2

Double blind

Doctor nor patient know if active or placebo drug is given to the patient, kept secret to the end of the trial

3

Single blind

Patient doesn't know but doctor does id the patient is give the active or the placebo drug

4

What is the purpose of pilot studies

Not to estimate outcome but to study pilot design

5

Prospective

design study, recruit patient and follow them up = study over time

6

Reterospecive

Not the data you have collected for the trial but compare other data from previous medical history

7

Placebo contolled study

half patents are given active drug while the other half receive placebo - comparisons made between similar patients who differ in certain characteristics

8

Cross over design

Half study drug other compared therapy
Wash out period
swap over treatment and see if treatment is better

9

Disadvantages of randomised control clinical trials

Subjects may not represent general patients
Tend to be better at complying
Recruitment = need twice as many patients
Some patients or physicians will refuse to randomise
Administrative complexity

10

Designing a study

Clear hypothesis
Should have an End point
Randomised double blind comparison
Number of subjects - need enough to be able to detect or reject
Decide your placebo "control drug"

11

What is the choice of patients dependant on

age
sex
race
any concurrent diseases + medication or drugs /
will they comply or continue to follow instructions

12

What kind of people may need to be excluded from studies

pregnant
children
seriously ill
elderly
side-effect risk patients


13

What are the features of Ethics with clinical trials

consent
ehtics comittee
decide on placebo
Children
Study designs
Policing studies
Make sure you have insurance
follow the law

14

Why are clinical trial necessary

provide evidence (medical practise = evidence based; need to critically evaluate evidence)
what works in theory might not be best in practise
test efficacy compared with placebo / another drug /
test safety = protect public
provide evidence to help rational prescribing
help inform doctors treating patients appropriately

15

What do clinical trials provide

evidence

16

What is phase one clinical studies

volunteer studies = some given active drug whilst some given placebo; usually paid + regulated environment

17

What is phase two clinical studies

patient studies = involves a fixed number of patients to investigate kinetics / dynamics in patients

18

what is phase three clinical studies

formal therapeutic trials = evidence of safety obtained; involves much larger group of patients; data compiled + submitted as an application to a regulatory authority for a licence to sell the drug

19

what is phase four clinical studies

post-marketing surveillance of drug to ensure long term safety = involves thousands of patients
MHRA = medicines + healthcare devices regulatory authority (committee on safety of medicines); uses yellow card system = GPs / hospital doctors / pharmacists

20

what is phase five clinical studies

drug in widespread clinical use = relative comparisons (is X > Y / Z); exploration of new uses for the drug

21

what is the placebo effect

patient makes an improvement

22

what does p=0.05 mean

p-value less than 0.05 leads us to conclude that there is evidence against the hypothesis