Introduction and Clinical Trials Flashcards Preview

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Flashcards in Introduction and Clinical Trials Deck (4)
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1
Q

why do we need clinical trials?

  • clinical trials separate therapies which are true advances from false leads and clinical impressions
  • importantly, they also identify risks fo therapy:
  • -_____
  • -_____
  • -_____
  • -interactions with _____, _____, _____
A
safety 
efficacy 
adverse effects
drugs
foods
disease
2
Q

history of US food and drug law

  • 1906 pure food and drug act: _____ industry
  • 1938 food, drug and cosmetic act: _____ 100 people died after _____ + _____
  • 1962 Kefauver Harris amendment: proof of safety and efficacy (_____) reporting of adverse events
  • 2007 FDA amendments act: COX 2 inhibitors _____ (_____)
A
meat
strep-elixir 
sulfonamide 
antifreeze 
thalidomide 
rofecoxib (Vioxx)
3
Q

clinical trials

  • prospective studies comparing the effect and value of an _____ in humans or sometimes animals
  • -can involve _____, _____, _____, etc
  • _____ required
  • in some settings, these are considered the standard of care e.g. many pediatric malignancies
A
intervention 
drugs
devices
procedures
informed consent
4
Q
what is the focus of a clinical drug trial?
examples:
-\_\_\_\_\_ of intervention to treat a disease
-\_\_\_\_\_ of a new drug
-defining \_\_\_\_\_
-testing \_\_\_\_\_
-exploring \_\_\_\_\_
-evaluating effect of therapies on \_\_\_\_\_
A
effectiveness
safety
dose administration
drug formulation 
combination therapies 
quality of life