Drug information

  1. types of clinical trials
    • treatment trials
    • prevention trials
    • quality of life trials
    • diagnostic trials
  2. phase 1 trials
    • determine metabolism and pharm actions
    • evaluates SE associate w/ inc doses
    • gain early evidence of effectiveness
  3. Phase II trials
    • controlled CT
    • evaluates effectivesness of the drug
    • includes pt with disease or condition
  4. Phase III trials
    • expanded controlled and uncontrolled trials
    • evaluate the ben-risk relationship of drug
    • provide adequate basis for labeling
  5. Phase IV trials
    • post marketing studies
    • delineate additional drug info (risks, benefits)
  6. what are arms
    any of the treatment groups in a randomized trial
  7. standard of care control
    the drug being tested is compared to the state of the art therapy for that condition
  8. historical control
    the drug being tested is compared to historical data of the use of another drug in pts that meet the same criteria
  9. inclusion criteria
    criteria everyone must have to join
  10. exclusion criteria
    characteristics taht people cannot have if they want ot join the trial
  11. Institutional Review Board
    required by fed regulation at every institution that conducts or supports biomedical or behavioral research
  12. who sponsors clinical trials
    usually NIH or drug manufacturers
  13. types of bias
    • recall
    • selection
    • publication
    • non response
  14. methods of eliminating bias
    • blinding
    • randomization
    • complete follow-up
    • unambiguous endpoint
  15. simple randomization
    random numbers
  16. blocked randomization
    randomization between bloacks of sequential participants
  17. stratified randomization
    randomization with clusters of participants
  18. primary endpoint
    usually an efficacy measure or routine and useful measure
  19. secondary endopoint
    important but not primary purpose of the study (usually ADEs, toxicity)
  20. composite endpoints
    • -utilized when accessing efficacy for different endpoints
    • -common with illnesses with high morbidity and mortality
  21. intent to treat analysis
    includes all data from participants in the group to which they were randomized
  22. per protocol
    evaluates data of only the subjects that completed the sudy per protocol
  23. external validity
    generalization of the results
  24. internal validity
    refers to the extent to which the study results reflect what actually happened in the study
  25. confounders are controlled by
    • randomization
    • restriction
    • matching
  26. 5 steps of EBM
    • asking focused questions
    • finding evidence
    • critical appraisal
    • making a decision
    • evaluating performance
  27. EBM guidlelines are usually sponsored by which organization
    • ACC/AHA
    • IDSA
    • ACCP
    • AAP
  28. examples of EB guideliness
    • JNC VII
    • ATP III
  29. the two types of grading
    • quality of evidence
    • strength of recommendations
  30. US preventive task force
    • convened by the US public health service
    • uses a systematic evidence-based methology to review the evidence of effectiveness of clinical preventive services
  31. level I
    evidence obtained from at least one properly designed RCT
  32. Level II-1
    well-designed controlled trials without randomization
  33. level II-2
    well designed cohort or case control studies
  34. level II-3
    multiple time series with or without the intervention
  35. level III
    opinions of selected authorities
  36. conclusion A
    good scientific evidence
  37. conclusion B
    benefits outweigh risks
  38. conclusion C
    balance between risk and benefits
  39. conclusion D
    risks outweigh benefits
  40. conclusion E
    scientific evidence is lacking
  41. what is PICO
    • patient/problem
    • intervention
    • comparison
    • outcomes
  42. evidence pyramid
    • meta analysis
    • RCT
    • cohort studies
    • case controlled studies
    • case series/reports
  43. where to find clinical practice guidelines
    • national guideline clearinghouse
    • Peer reviewed lit
    • cochrane reviews
Card Set
Drug information
PT 1 exam