Method and kit for treating illnesses
First Claim
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1. A method of evaluating the therapeutic response of individual human patients to chronic therapy with a drug, comprising:
- a) assembling from a plurality of crossover single patient drug trials a patient population database of information concerning the safety, efficacy and desirability of a drug administered according to a randomized, double-blind schedule with a placebo, said drug being selected from the group consisting of a drug for treating hyperkinetic behavior, an anti-depressant drug, an anti-anxiety drug, an anti-asthmatic drug, an anti-epileptic drug, an anti-psychotic drug, a cardiovascular drug, a respiratory drug, an antihypertensive drug, an anti-diabetic drug, a steroidal anti-inflammatory drug, a non-steroidal anti-inflammatory drug, an opioid analgesic, a non-narcotic analgesic drug, an anti-cancer drug, a hematologic drug, a musculoskeletal drug, a gastro-intestinal drug, and anti-allergy drug, an estrogen-containing drug, a drug for the treatment of urinary tract conditions, a drug for the treatment of genital conditions, a drug for the treatment of neurologic conditions, and a drug for the treatment of psychiatric conditions;
b) conducting a randomized, double-blind, cross-over, single patient drug trial of said drug and said placebo in a new patient who is a candidate for treatment with said drug;
c) comparing the information accumulated from the patient population database with the information from the single patient drug trial of said new patient to aid in the interpretation of the results for said new patient;
d) optimizing treatment for said new patient by taking one of the following actions;
(i) continuing therapy for said new patient using the same drug and dosage regimen;
(ii) changing the dosage regimen of the same drug in order to optimize the dosage regimen for said new patient;
or (iii) ceasing to treat said new patient with said drug if the patient is not achieving a desired benefit from treatment with said drug; and
e) adding the results from the single patient drug trial of said new patient to the patient population database.
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Abstract
Methods and kits for determining appropriate treatment for illnesses in humans or animals are disclosed. The method includes:
providing a test kit containing a random arrangement of drug(s) and placebo(s) and/or alternative treatment(s) along with a questionnaire or other instrument designed to elicit data concerning the safety, efficacy and desirability of a treatment;
administering the drug(s) and placebo(s) and/or alternative treatments to each member of the pool in a random, double blind fashion and following up on patient outcomes as appropriate post-study;
assembling a database from the completed pool questionnaires and revealing the random schedule to uncover drug and placebo treatment periods;
providing the same kit to a patient in need of the same treatment and comparing the results obtained from the single patient trial with those obtained from the pool to determine an optimal treatment for the patient with the drug; and
administering a treatment consistent with the optimal treatment.
22 Citations
47 Claims
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1. A method of evaluating the therapeutic response of individual human patients to chronic therapy with a drug, comprising:
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a) assembling from a plurality of crossover single patient drug trials a patient population database of information concerning the safety, efficacy and desirability of a drug administered according to a randomized, double-blind schedule with a placebo, said drug being selected from the group consisting of a drug for treating hyperkinetic behavior, an anti-depressant drug, an anti-anxiety drug, an anti-asthmatic drug, an anti-epileptic drug, an anti-psychotic drug, a cardiovascular drug, a respiratory drug, an antihypertensive drug, an anti-diabetic drug, a steroidal anti-inflammatory drug, a non-steroidal anti-inflammatory drug, an opioid analgesic, a non-narcotic analgesic drug, an anti-cancer drug, a hematologic drug, a musculoskeletal drug, a gastro-intestinal drug, and anti-allergy drug, an estrogen-containing drug, a drug for the treatment of urinary tract conditions, a drug for the treatment of genital conditions, a drug for the treatment of neurologic conditions, and a drug for the treatment of psychiatric conditions;
b) conducting a randomized, double-blind, cross-over, single patient drug trial of said drug and said placebo in a new patient who is a candidate for treatment with said drug;
c) comparing the information accumulated from the patient population database with the information from the single patient drug trial of said new patient to aid in the interpretation of the results for said new patient;
d) optimizing treatment for said new patient by taking one of the following actions;
(i) continuing therapy for said new patient using the same drug and dosage regimen;
(ii) changing the dosage regimen of the same drug in order to optimize the dosage regimen for said new patient;
or (iii) ceasing to treat said new patient with said drug if the patient is not achieving a desired benefit from treatment with said drug; and
e) adding the results from the single patient drug trial of said new patient to the patient population database. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 25, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44)
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24. A method of evaluating the therapeutic response of individual human patients to chronic therapy with a drug, comprising:
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a) assembling from a plurality of crossover single patient drug trials a patient population database of information concerning the safety, efficacy and desirability of a drug administered according to a randomized, double-blind schedule with a second agent selected from the group consisting of a placebo, a therapeutic alternative for said drug, and a generic equivalent for said drug;
said drug being selected from the group consisting of a drug for treating hyperkinetic behavior, an anti-depressant drug, an anti-anxiety drug, an anti-asthmatic drug, an anti-epileptic drug, an anti-psycotic drug, a cardiovascular drug, a respiratory drug, an antihypertensive drug, an anti-diabetic drug, a steroidal anti-inflammatory drug, a non-steroidal anti-inflammatory drug, an opioid analgesic, a non-narcotic analgesic drug, an anti-cancer drug, a hematologic drug, a musculoskeletal drug, a gastro-intestinal drug, a anti-allergy drug, an estrogen-containing drug, a drug for the treatment of urinary tract conditions, a drug for the treatment of genital conditions, a drug for the treatment of neurological conditions, and a drug for the treatment of psychiatric conditions;
by providing to each patient in said patient population a test kit containing a supply of said drug;
a supply of said second agent; and
a questionnaire designed to elicit from said patient population information concerning the actual usage, safety, efficacy and desirability of said drug;
b) conducting in a new patient who is a candidate for treatment with said drug a randomized, double-blind, cross-over, single patient drug trial of said drug and the same second agent administered to the patient population of step (a), by providing to said new patient a test kit containing a supply of said drug;
a supply of said second agent; and
a questionnaire designed to elicit from said new patient information concerning the actual usage, safety, efficacy and desirability of said drug;
c) comparing the information accumulated from the patient population database with the information from the single patient drug trial of said new patient to aid in the interpretation of the results for said new patient;
d) optimizing treatment for said new patient by taking one of the following actions;
(i) continuing therapy for said new patient using the same drug and dosage regimen;
(ii) changing the dosage regimen of the same drug in order to optimize the dosage regimen for said new patient;
(iii) ceasing to treat said new patient with said drug if said new patient is not achieving a desired benefit from treatment, or (iv) changing said new patient to chronic therapy using a therapeutic alternative or generic equivalent of said drug; and
e) adding the results from said single patient drug trial of said new patient to the patient population database. - View Dependent Claims (26, 27, 28, 45)
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46. A method of evaluating the therapeutic response of individual human patients to chronic therapy with a drug, comprising:
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a) assembling from a plurality of crossover single patient drug trials a patient population database of information concerning the safety, efficacy and desirability of a drug administered according to a randomized, double-blind schedule with a placebo, said drug being selected from the group consisting of a drug for treating hyperkinetic behavior, an anti-depressant drug, an anti-anxiety drug, an anti-asthmatic drug, an anti-epileptic drug, an anti-psychotic drug, a cardiovascular drug, a respiratory drug, an antihypertensive drug, an anti-diabetic drug, a steroidal anti-inflammatory drug, a non-steroidal anti-inflammatory drug, an opioid analgesic, a non-narcotic analgesic drug, an anti-cancer drug, a hematologic drug, a musculoskeletal drug, a gastro-intestinal drug, and anti-allergy drug, an estrogen-containing drug, a drug for the treatment of urinary tract conditions, a drug for the treatment of genital conditions, a drug for the treatment of neurologic conditions, and a drug for the treatment of psychiatric conditions;
b) conducting a randomized, double-blind, cross-over, single patient drug trial of said drug and said placebo in a new patient who is a candidate for treatment with said drug;
c) comparing the information accumulated from the patient population database with the information from the single patient drug trial of said new patient to aid in the interpretation of the results for said new patient;
d) optimizing treatment for said new patient by taking one of the following actions;
(i) continuing therapy for said new patient using the same drug and dosage regimen;
(ii) changing the dosage regimen of the same drug in order to optimize the dosage regimen for said new patient;
or (iii) ceasing to treat said new patient with said drug if the patient is not achieving a desired benefit from treatment with said drug.
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47. A method of evaluating the therapeutic response of individual human patients to chronic therapy with a drug, comprising:
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a) assembling from a plurality of crossover single patient drug trials a patient population database of information concerning the safety, efficacy and desirability of a drug administered according to a randomized, double-blind schedule with a second agent selected from the group consisting of a placebo, a therapeutic alternative for said drug, and a generic equivalent for said drug;
said drug being selected from the group consisting of a drug for treating hyperkinetic behavior, an anti-depressant drug, an anti-anxiety drug, an anti-asthmatic drug, an anti-epileptic drug, an anti-psychotic drug, a cardiovascular drug, a respiratory drug, an antihypertensive drug, an anti-diabetic drug, a steroidal anti-inflammatory drug, a non-steroidal anti-inflammatory drug, an opioid analgesic, a non-narcotic analgesic drug, an anti-cancer drug, a hematologic drug, a musculoskeletal drug, a gastro-intestinal drug, a anti-allergy drug, an estrogen-containing drug, a drug for the treatment of urinary tract conditions, a drug for the treatment of genital conditions, a drug for the treatment of neurologic conditions, and a drug for the treatment of psychiatric conditions;
by providing to each patient in said patient population a test kit containing a supply of said drug;
a supply of said second agent; and
a questionnaire designed to elicit from said patient population information concerning the actual usage, safety, efficacy and desirability of said drug;
b) conducting in a new patient who is a candidate for treatment with said drug a randomized, double-blind, cross-over, single patient drug trial of said drug and the same second agent administered to the patient population of step (a), by providing to said new patient a test kit containing a supply of said drug;
a supply of said second agent; and
a questionnaire designed to elicit from said new patient information concerning the actual usage, safety, efficacy and desirability of said drug;
c) comparing the information accumulated from the patient population database with the information from the single patient drug trial of said new patient to aid in the interpretation of the results for said new patient;
d) optimizing treatment for said new patient by taking one of the following actions;
(i) continuing therapy for said new patient using the same drug and dosage regimen;
(ii) changing the dosage regimen of the same drug in order to optimize the dosage regimen for said new patient;
(iii) ceasing to treat said new patient with said drug if said new patient is not achieving a desired benefit from treatment, or (iv) changing said new patient to chronic therapy using a therapeutic alternative or generic equivalent of said drug.
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Current AssigneeOpt-e-scrip, Inc.
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Original AssigneeOpt-e-scrip, Inc.
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InventorsReitberg, Donald P.
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Primary Examiner(s)Geist, Gary
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Assistant Examiner(s)CHAUDHRY, MAHREEN F
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Application NumberUS08/331,913Time in Patent Office2,409 DaysField of Search514/317, 514/654, 514/652US Class Current514/317CPC Class CodesG16H 10/20 for electronic clinical tri...G16H 10/60 for patient-specific data, ...G16H 20/00 ICT specially adapted for t...G16H 20/10 relating to drugs or medica...
