IPC분류정보
국가/구분 |
United States(US) Patent
등록
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국제특허분류(IPC7판) |
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출원번호 |
US-0975814
(2001-10-11)
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발명자
/ 주소 |
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출원인 / 주소 |
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대리인 / 주소 |
Green, Esq., RezaBork, Esq., Richard W.Began, Esq., Marc A.
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인용정보 |
피인용 횟수 :
2 인용 특허 :
4 |
초록
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A method for clinical surveillance of a treatment group and an other group involves defining an adverse event, possible a serious adverse event, noting each occurrence of the adverse events, and, starting at zero, calculating a cumulative sum of the adverse events by updating the cumulative sum each
A method for clinical surveillance of a treatment group and an other group involves defining an adverse event, possible a serious adverse event, noting each occurrence of the adverse events, and, starting at zero, calculating a cumulative sum of the adverse events by updating the cumulative sum each time a further adverse event is reported and, when the adverse event is in the treatment group, adding 1 to the cumulative sum, and, when the adverse event is in the other group, adding 0 to the cumulative sum. This invention also involves subtracting a chosen quantity K from the cumulative sum, comparing the cumulative sum to a predetermined alarm limit, determining when the cumulative sum reaches at least the predetermined alarm limit, and indicating the predetermined alarm limit has been reached.
대표청구항
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1. A method for clinical surveillance of a treatment group and an other group, comprising the steps of: defining a type of an adverse event; noting each occurrence of the defined adverse event; obtaining a value by; calculating, starting at zero, a cumulative sum of the noted adverse events b
1. A method for clinical surveillance of a treatment group and an other group, comprising the steps of: defining a type of an adverse event; noting each occurrence of the defined adverse event; obtaining a value by; calculating, starting at zero, a cumulative sum of the noted adverse events by; updating the cumulative sum each time a further adverse event is noted; and when the noted adverse event is in the treatment group, adding 1 to the cumulative sum, and when the noted adverse event is in the other group, adding 0 to the cumulative sum; subtracting a chosen quantity K from the cumulative sum; comparing the cumulative sum to a predetermined alarm limit; and determining when the cumulative sum reaches at least the predetermined alarm limit. 2. A method for clinical surveillance according to claim 1, further comprising the step of indicating the predetermined alarm limit has been reached. 3. A method for clinical surveillance according to claim 1, wherein in the step of defining, plural types of adverse events are defined. 4. A method for clinical surveillance according to claim 1, wherein the predetermined alarm limit has a value H chosen to obtain a low risk of a false alarm where there is no safety problem. 5. A method for clinical surveillance according to claim 1, wherein the cumulative sum of the adverse events is determined using a formula Si=max{c,Si-1+Ni-K}, i=1,2, . . . where Siis the cumulative sum, S0=0, and Niis an indicator function of an ith event occurring in the treatment group. 6. A method for clinical surveillance according to claim 5, wherein an alarm event is a first event number (i) such that Si≥H. 7. A method for clinical surveillance according to claim 5, wherein c is a chosen constant and -∞≤c≤0. 8. A method for clinical surveillance according to claim 1, further comprising a step of unblinding those participants experiencing the adverse events when the cumulative sum reaches the predetermined alarm limit. 9. A method for clinical surveillance according to claim 1, wherein the step of calculating is performed for less than all of the adverse events. 10. A method for clinical surveillance according to claim 1, wherein the step of calculating is performed for each n adverse events, n being an integer having a value of at least 1. 11. A method for clinical surveillance according to claim 1, wherein the step of calculating is performed at regular intervals. 12. A method for clinical surveillance according to claim 1, wherein the step of calculating is performed at random intervals. 13. A computer-readable storage medium having a program for performing the method of claim 1. 14. A method for administering a clinical surveillance program to a treatment group and an other group, comprising the steps of: identifying an adverse event to be monitored in the clinical surveillance program; evaluating an expected number of years of observation for trials; setting a rate per year of the adverse events; determining an expected number of the adverse events; choosing an accepted proportion of the adverse events that may be in the treatment group; choosing an alternative value of the proportion in the treatment group; choosing K as a number near a value found in a formula K=-[log {(1-p0)/(1-p1)}]/log[p0(1-p1)/{p1(1-p0)}].
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