Introduction and Clinical Trials Flashcards
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
