Applying survival methodology to adverse experience occurrences in controlled clinical trials.
On the basis of calculated cumulative hazard rates for initial occurrence of adverse experiences of patients following treatment for rheumatoid arthritis and osteoarthritis, a simple function is evolved that fits such cumulative hazard rate data very well. From this simple function, we obtain the estimated hazard rate in terms of two physically meaningful parameters. These two parameters can be used to describe the rate of occurrence of adverse experiences, and to convey the concept of risk of adverse experience associated with duration of exposure to a drug. The parameters are rho 1, which represents the risk of adverse experience at baseline, and rho 2, which defines the rate of occurrence of adverse experience immediately following drug administration. A method of estimating rho 1 and rho 2 is the maximum likelihood approach, and the estimated parameters are given for series of data referring to patients treated for arthritis.
Bortey
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EB
Norwich Eaton Pharmaceuticals, Inc., Proctor & Gamble Company, Biometric Systems, New York 13815.
Gould
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AL
D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D016019:Survival Analysis