Drug information

• treatment trials
• prevention trials
• quality of life trials
• diagnostic trials

• determine metabolism and pharm actions
• evaluates SE associate w/ inc doses
• gain early evidence of effectiveness

• controlled CT
• evaluates effectivesness of the drug
• includes pt with disease or condition

• expanded controlled and uncontrolled trials
• evaluate the ben-risk relationship of drug
• provide adequate basis for labeling

• post marketing studies
• delineate additional drug info (risks, benefits)

any of the treatment groups in a randomized trial

the drug being tested is compared to the state of the art therapy for that condition

the drug being tested is compared to historical data of the use of another drug in pts that meet the same criteria

criteria everyone must have to join

characteristics taht people cannot have if they want ot join the trial

required by fed regulation at every institution that conducts or supports biomedical or behavioral research

usually NIH or drug manufacturers

• recall
• selection
• publication
• non response

• blinding
• randomization
• complete follow-up
• unambiguous endpoint

random numbers

randomization between bloacks of sequential participants

randomization with clusters of participants

usually an efficacy measure or routine and useful measure

important but not primary purpose of the study (usually ADEs, toxicity)

• -utilized when accessing efficacy for different endpoints
• -common with illnesses with high morbidity and mortality

includes all data from participants in the group to which they were randomized

evaluates data of only the subjects that completed the sudy per protocol

generalization of the results

refers to the extent to which the study results reflect what actually happened in the study

• randomization
• restriction
• matching

• asking focused questions
• finding evidence
• critical appraisal
• making a decision
• evaluating performance

• ACC/AHA
• IDSA
• ACCP
• AAP

• JNC VII
• ATP III

• quality of evidence
• strength of recommendations

• convened by the US public health service
• uses a systematic evidence-based methology to review the evidence of effectiveness of clinical preventive services

evidence obtained from at least one properly designed RCT

well-designed controlled trials without randomization

well designed cohort or case control studies

multiple time series with or without the intervention

opinions of selected authorities

good scientific evidence

benefits outweigh risks

balance between risk and benefits

risks outweigh benefits

scientific evidence is lacking

• patient/problem
• intervention
• comparison
• outcomes

• meta analysis
• RCT
• cohort studies
• case controlled studies
• case series/reports

• national guideline clearinghouse
• Peer reviewed lit
• cochrane reviews