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STA 291 Spring 2007

STA 291 Spring 2007. Collecting Data --- Experiments Example: testing of new treatments or drugs via clinical trials. Testing a new product, etc. Clinical trial: Double blinded , placebo controlled , randomized .

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STA 291 Spring 2007

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  1. STA 291 - Spring 2007 - Lecture 7 STA 291Spring 2007 • Collecting Data --- Experiments • Example: testing of new treatments or drugs via clinical trials. • Testing a new product, etc.

  2. Clinical trial: Double blinded, placebo controlled, randomized. • recruit volunteers that met specific requirements (have certain conditions). Statistician will decide how much subjects is enough. (usually 100 to 1000, depending on what you are looking for, what is the budget, how certain the result need be ….)

  3. Randomly decide if a subject is given the new drug or placebo (sugar pill). Usually 50%-50% chance. • Neither the subject nor the attending doctor know which is given to the subject. (to minimize psychological effects, also called placebo effects) • Only a high level committee know.

  4. The idea is to match as closely as possible the subjects of the two groups. The only difference is the drug. • The phrase “if everything else remain the same, the use of the drug for XXX patients can reduce the 5 year mortality rate by X%” etc.

  5. Resulting data are analyzed by statistical procedure. (cover later) • Conclusion might be “proven beyond reasonable doubt that the new drug is better”. Or • Inconclusive…either no effect or the results too noisy that you do not see it clearly, or • Clearly No effect.

  6. More than 40% of clinical trials result in abandon of the drug. Very costly. (Hundreds of millions $) • Any drug company announcing the abandoning of a (phase III) clinical trial usually make their stock price go down significantly. • Vioxx, phen-fen, ……Purdue Pharma to Withdraw Palladone ….

  7. Martha Stewart went to jail because of selling a drug company stock with inside information and then lie about it. • Info: ImClone’s new drug was not statistically proven to be effective, Food and Drug Administration determined.

  8. STA 291 - Spring 2007 - Lecture 7 Attendance Survey Question • On a 4”x6” index card • Please write down your name and section number • Today’s Question:

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