Clinical Trial Flashcards

1
Q

Why are clinical trials important?

A

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

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2
Q

What is a problem with observation studies?

A

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

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3
Q

What are clinical trial?

A

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

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4
Q

What does the reliability depend on?

A

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

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5
Q

What is a double blinded clinical trial?

A

Patient and doctor both unaware of what drugs patient is on

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6
Q

What is a single blinded clinical trial?

A

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

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7
Q

What is a prospective clinical trial?

A

Protocol decided before hand

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8
Q

What is a retrospective clinical trial?

A

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

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9
Q

What is a placebo controlled study?

A

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

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10
Q

What is a study of comparison with other therapy?

A

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

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11
Q

What is a cross over trial?

A

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

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12
Q

What is a randomised control clinical trial?

A

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

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13
Q

Disadvantages of randomised control clinical trial

A
  • 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
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14
Q

What is a superiority design?

A

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

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15
Q

What is a non-inferiority design?

A

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
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16
Q

What are possible end points in drug trials?

A
  • Death
  • No. of hospital admissions
  • Lowering of blood pressure
  • Compare pain control or change in mood
17
Q

Stages in clinical trials

A
  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
Q

What does p<0.05 indicate?

A

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