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Flashcards in Clinical Trial Deck (18):
1

Why are clinical trials important?

-Provide evidence for: medical practice and SIGN guideline or formulary and many drug treatments (I.e. for stroke, cancer, rheumatoid arthritis)

2

What is a problem with observation studies?

Clinical impressions of the efficacy of a drug are often misleading because of bias, the selectivity of doctors’ memories and the placebo effect

3

What are clinical trial?

A way of testing the efficacy of a drug can be tested and proven
It may indicate the risks involved with drug use

4

What does the reliability depend on?

The trial design, trial procedure and conduct and trial analysis.

5

What is a double blinded clinical trial?

Patient and doctor both unaware of what drugs patient is on

6

What is a single blinded clinical trial?

Patient unaware of what drugs they are taking but doctor is aware (stent stud)

7

What is a prospective clinical trial?

Protocol decided before hand

8

What is a retrospective clinical trial?

A drug trial where data is collected from case record after treatment is given - less good as open to bias

9

What is a placebo controlled study?

Equal number of subjects and one given placebo and one given active drug and then outcomes of both groups compared

10

What is a study of comparison with other therapy?

Equal number of subjects that were part of a drug trial and others who were part of a comparitive therapy trial and then compare outcomes of both trial

11

What is a cross over trial?

Two groups of equal numbers which were either part of a compared therapy or drug study and in the cross over design (after 8 week wash out period) they swap trials

12

What is a randomised control clinical trial?

Patients assigned at random to either treatment(s) or control

13

Disadvantages of randomised control clinical trial

-Subjects may not represent general patient population and are better at complying
-Twice as many new patients required for study
-Accepting that it's random: some doctors refuse (PFO closure) and some patients will refuse treatment
-Administration complexity as its random

14

What is a superiority design?

Shows that the new treatment is better than the control or standard

15

What is a non-inferiority design?

Show that new treatments:
-is not worse that standard by more then certain margin
-would have beaten placebo if a placebo arm had been included

16

What are possible end points in drug trials?

-Death
-No. of hospital admissions
-Lowering of blood pressure
-Compare pain control or change in mood

17

Stages in clinical trials

1. Drug discovery
2. Preclinical development: animal pharmacology (ADRs), toxicology (teratogenicity, mutagenicity) and tissue culture
3. Volunteer studies (phase I) pharmacology in normal volunteers (Cmax, Vd, metabolism, elimination etc)
4. Volunteers (phase II): confirm kinetic and dynamics
5. Phase III: formal trials to determine efficacy
6. Phase IV: post-marketing surveillance for evidence of safety - tested on patients

18

What does p<0.05 indicate?

Taken as significant and indicates that no changes occurred due to chance