Term
| What is a Clinical Trial? |
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Definition
-Design that allows comparison of Tx outcomes amon two or more groups evaluated simultaneously
-Strongest evidence for causation
-Least # of problems or biases
-Expensive/Time consuming
-Comparison of therapies, comparison of new therapy to placebo, or more than 2 Txs |
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Term
| What is Evidence-Based Medicine? |
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Definition
| -The integration of the current best evidence with clinical expertise, pathophysiological knowledge, and pt preferences to make healthcare decisions |
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Term
| What is Phase I of a Clinical Trial? |
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Definition
-1st studies in people that evaluate how a new drug should be given, how often, and what dose is safe
-Usually <12 healthy pts
-Must be studied for safety in animals first |
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Term
| What is Phase II of a Clinical Trial? |
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Definition
-Focuses on drug safety and secondarily evaluated efficacy
-<200 pts, healthy and sick
-Appropriate dose and route usually known |
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Term
| What is Phase III of a Clinical Trial? |
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Definition
-Test new drug, drug combo, or Sx in comparison to a "standard care" of tx
-250-10,000 with specific Dz
-Aimed at FDA approval
-Years, millions of dollars |
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Term
| What is Phase IV of a Clinical Trial? |
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Definition
-Post marketing surveillance trial on already approved drugs
-Safety surveillance
-Used to pursue a new indication, or a trial of a drug in a new population |
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