Single-patient drug trials used with accumulated database: flowchart

• US 20020192159A1
• Filed: 06/01/2001
• Published: 12/19/2002
• Est. Priority Date: 06/01/2001
• Status: Abandoned Application

• Current Assignee: Opt-e-scrip, Inc.
• Original Assignee: Opt-e-scrip, Inc.
• Inventors: Reitberg, Donald P.
• Application Number:
  US09/872,815
• Publication Number:
  US 20020192159A1
• Time in Patent Office: Days
• US Class Current: 424/9.1
• CPC Class Codes: A61K 49/0004 Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients

Abstract

A method of evaluating and/or optimizing clinical outcomes and providing rational pharmacotherapy in an individual or animal requiring chronic drug therapy is provided.

Claims

1. A method of optimizing clinical outcomes and providing pharmacotherapy in an individual human patient for whom chronic drug therapy is contemplated, comprising:

a) determining a first drug for treatment of an individual human patient for whom chronic drug therapy is contemplated, and a second drug which may alternatively be useful for treatment of the individual human patient;

b) conducting a single patient cross-over drug trial in the individual human patient via a switchability test utilizing a supply of the first drug;

a supply of the second drug, and optionally a supply of placebo; and

accumulating information concerning the safety, effectiveness, patient compliance and desirability of the first drug, the second drug and optionally the placebo;

c) evaluating whether safety, effectiveness, patient compliance and desirability is acceptable for both the first drug and the second drug;

one of the first drug and the second drug;

or neither the first drug or the second drug, optionally as compared to the placebo, by comparing the results of the single patient drug trial of the individual human patient with a previously assembled patient population database of information concerning the safety, effectiveness, patient compliance and desirability of the first drug, the second drug and optionally the placebo administered in a plurality of cross-over single patient drug trials, to aid in the interpretation of the results for the new patient; and

d) optimizing treatment for the patient by taking one of the following actions;

(i) if safety, effectiveness, patient compliance and desirability is acceptable for both the first drug and the second drug, initiating chronic therapy for the individual human patient using the first drug or the second drug, taking into account the relative benefits of each drug based on the results of the evaluation of safety, effectiveness, patient compliance and desirability of the first drug and the second drug as compared to the patient population database, as well as the relative cost of the first drug and the second drug;

(ii) if safety, effectiveness, patient compliance and desirability are acceptable for only one of the first drug and the second drug, initiating chronic therapy for the individual human patient using the acceptable one of the first drug or the second drug;

(iii) if safety, effectiveness, patient compliance and desirability are not acceptable for either of the first drug and the second drug, discontinuing treatment or repeating steps (b)-(d) utilizing third and fourth alternative drugs, if available.

2. The method of claim 1, further comprising assembling said patient population database from a plurality of cross-over single patient drug trials prior to conducting step (a).

3. The method of claim 1, further comprising adding the results from the single patient drug trial of the individual human patient to the patient population database.

4. The method of claim 1, further comprising accumulating the information of step (b) via the use of objective testing methodologies selected from the group consisting of blood pressure, cholesterol, blood sugar, glycosylated hemoglobin and combinations of any of the foregoing.

5. The method of claim 1, further comprising including a questionnaire in said test, said questionnaire designed to elicit from said individual patient or caretaker information concerning the actual usage, safety, effectiveness and desirability of said drug and said second agent.

6. The method of claim 1, further comprising prescribing said first drug for chronic therapy in said patient.

7. The method of claim 1, further comprising prescribing said second drug for chronic therapy in said patient.

8. The method of claim 1, wherein said patient population database is stored on a computer.

9. The method of claim 8, wherein said computer database is accessible from a remote location.

10. The method according to claim 1, wherein said drug or said second drug is selected from the group consisting of a drug for treating hyperkinetic behavior, cancer, schizophrenia, minimal brain dysfunction, mania, alzheimer'"'"'s disease, attention deficit disorder (ADD), angina, congestive heart failure, cardiac arrhythmias, pain, metabolic disorders, endocrine disorders, obesity, neurologic disorders, immunologic diseases, eye disorders, ear disorders, sleep disorders, central nervous system disorders, urinary tract disorders, renal disorders, genito-urinary disorders, erectile dysfunction, podiatric disorders, chiropractic disorders, geriatric conditions, anti-asthmatic agents, dental agents, anti-epileptic agents, anti-psychotic agents, anti-depressants, cardiovascular agents, respiratory agents, neurological agents, antihypertensive agents, diabetic agents, steroidal and non-steroidal anti-inflammatory agents, opiates, narcotic and non-narcotic analgesics, hematologic agents, musculoskeletal agents, anti-anxiety agents, gastro-intestinal agents, dermatologic agents;

and anti-allergy medications.

11. The method according to claim 1, wherein said switchability test comprises a supply of a drug therapy;

a supply of a second drug therapy; and

a questionnaire designed to elicit from said individual or caretaker information concerning the actual usage, safety, effectiveness and desirability of said drug therapy and said second drug therapy.

13. The method of claim 12, further comprising assembling said patient population database from a plurality of cross-over single patient drug trials prior to conducting step a.

14. The method of claim 12, further comprising adding the results from the single patient drug trial of the individual human patient to the patient population database.

15. The method of claim 12, further comprising accumulating the information of step (b) via the use of objective testing methodologies selected from the group consisting of blood pressure, cholesterol, blood sugar, glycosylated hemoglobin and combinations of any of the foregoing.

16. The method of claim 12, further comprising including a questionnaire in said test, said questionnaire designed to elicit from said individual patient or caretaker information concerning the actual usage, safety, effectiveness and desirability of said drug and said second agent.

17. The method of claim 12, further comprising prescribing said drug for chronic therapy in said patient.

18. The method of claim 12, wherein said patient population database is stored on a computer.

19. The method of claim 18, wherein said computer database is accessible from a remote location.

20. The method according to claim 12, wherein said drug is selected from the group consisting of a drug for treating hyperkinetic behavior, cancer, schizophrenia, minimal brain dysfunction, mania, alzheimer'"'"'s disease, attention deficit disorder (ADD), angina, congestive heart failure, cardiac arrhythmias, pain, metabolic disorders, endocrine disorders, obesity, neurologic disorders, immunologic diseases, eye disorders, ear disorders, sleep disorders, central nervous system disorders, urinary tract disorders, renal disorders, genito-urinary disorders, erectile dysfunction, podiatric disorders, chiropractic disorders, geriatric conditions, anti-asthmatic agents, dental agents, anti-epileptic agents, anti-psychotic agents, anti-depressants, cardiovascular agents, respiratory agents, neurological agents, antihypertensive agents, diabetic agents, steroidal and non-steroidal anti-inflammatory agents, opiates, narcotic and non-narcotic analgesics, hematologic agents, musculoskeletal agents, anti-anxiety agents, gastro-intestinal agents, dermatologic agents;

and anti-allergy medications.

21. The method of claim 12, wherein said prescribability test kit comprises a supply of a drug therapy;

a supply of placebo; and

a questionnaire designed to elicit from said individual or caretaker information concerning the actual usage, safety, effectiveness and desirability of said drug therapy and said placebo.

12. A method of optimizing clinical outcomes and providing pharmacotherapy in an individual human patient for whom chronic drug therapy is contemplated, comprising:

a) determining a drug for treatment of an individual human patient for whom chronic drug therapy is contemplated;

b) conducting a single patient cross-over drug trial in the individual human patient via a prescribability test utilizing a supply of the drug and a supply of a placebo; and

accumulating information concerning the safety, effectiveness, patient compliance and desirability of the drug, and the placebo;

c) evaluating whether safety, effectiveness, patient compliance and desirability is more acceptable for the drug than the placebo;

more acceptable for the placebo than the drug;

or equivalent for both the drug and the placebo, by comparing the results of the single patient drug trial of the individual human patient with a previously assembled patient population database of information concerning the safety, effectiveness, patient compliance and desirability of the drug and the placebo administered in a plurality of cross-over single patient drug trials, to aid in the interpretation of the results for the new patient; and

d) optimizing treatment for the new patient by taking one of the following actions;

(i) if safety, effectiveness, patient compliance and desirability are more acceptable for the drug, initiating chronic therapy for the individual human patient using the drug, taking into account the relative benefits of the drug based on the results of the evaluation of safety, effectiveness, patient compliance and desirability of the drug and the placebo as compared to the patient population database;

(ii) if safety, effectiveness, patient compliance and desirability are more acceptable for the placebo, initiating chronic therapy for the individual human patient using the placebo or a low risk, less costly alternative therapy;

(iii) if safety, effectiveness, patient compliance and desirability are not acceptable for the drug and the placebo, discontinuing treatment or repeating steps (b)-(d) utilizing a second drug and placebo, if available; and

thereafter if safety, effectiveness, patient compliance and desirability are more acceptable for the second drug, initiating chronic therapy for the individual human patient using the second drug.

22. The method of claims 12, further comprising prescribing said second drug for chronic treatment of said patient.

24. The method of claim 23, further comprising assembling said patient population database from a plurality of cross-over single patient drug trials prior to conducting step a.

25. The method of claim 23, further comprising adding the results from the single patient drug trial of the individual human patient to the patient population database.

26. The method of claim 23, further comprising accumulating the information of step (b) via the use of objective testing methodologies selected from the group consisting of blood pressure, cholesterol, blood sugar, glycosylated hemoglobin and combinations of any of the foregoing.

27. The method of claim 23, further comprising including a questionnaire in said test, said questionnaire designed to elicit from said individual patient or caretaker information concerning the actual usage, safety, effectiveness and desirability of said drug and said second agent.

28. The method of claim 23, further comprising prescribing said first dose of drug for chronic therapy in said patient.

29. The method of claim 23, further comprising prescribing said second dose of drug for chronic therapy in said patient.

30. The method of claim 23, wherein said patient population database is stored on a computer.

31. The method of claim 30, wherein said computer database is accessible from a remote location.

32. The method according to claim 23, wherein said drug is selected from the group consisting of a drug for treating hyperkinetic behavior, cancer, schizophrenia, minimal brain dysfunction, mania, alzheimer'"'"'s disease, attention deficit disorder (ADD), angina, congestive heart failure, cardiac arrhythmias, pain, metabolic disorders, endocrine disorders, obesity, neurologic disorders, immunologic diseases, eye disorders, ear disorders, sleep disorders, central nervous system disorders, urinary tract disorders, renal disorders, genito-urinary disorders, erectile dysfunction, podiatric disorders, chiropractic disorders, geriatric conditions, anti-asthmatic agents, dental agents, anti-epileptic agents, anti-psychotic agents, anti-depressants, cardiovascular agents, respiratory agents, neurological agents, antihypertensive agents, diabetic agents, steroidal and non-steroidal anti-inflammatory agents, opiates, narcotic and non-narcotic analgesics, hematologic agents, musculoskeletal agents, anti-anxiety agents, gastroin-testinal agents, dermatologic agents;

and anti-allergy medications.

33. The method of claim 23, wherein said dosability test kit comprises a supply of a high dose of drug therapy;

a supply of a low dose of drug therapy; and

a questionnaire designed to elicit from said individual or caretaker information concerning the actual usage, safety, effectiveness and desirability of said high dose of drug therapy and said low dose of drug therapy.

34. The method of claim 23, further comprising prescribing said high dose of drug therapy.

35. The method of claim 23, further comprising prescribing said low dose of drug therapy.

23. A method of optimizing clinical outcomes and providing optimized pharmacotherapy in an individual human patient for whom chronic drug therapy is contemplated, comprising:

a) determining a first dose of a drug for treatment of an individual human patient for whom chronic drug therapy is contemplated, and a second dose of the same drug which may alternatively be useful for treatment of the individual human patient;

b) conducting a single patient cross-over drug trial in the individual human patient via a dosability test utilizing a supply of the first dose of drug and a supply of the second dose of the same drug; and

accumulating information concerning the safety, effectiveness, patient compliance and desirability of the first dose of drug, and the second dose of the same drug;

c) evaluating whether safety, effectiveness, patient compliance and desirability are more acceptable for the first dose of drug than the second dose of the same drug;

the second dose of drug than the first dose of the same drug;

or neither the first dose of drug or the second dose of the same drug, by comparing the results of the single patient drug trial of the individual human patient with a previously assembled patient population database of information concerning the safety, effectiveness, patient compliance and desirability of the first dose of drug and the second dose of the same drug administered in a plurality of crossover single patient drug trials, to aid in the interpretation of the results for the new patient; and

d) optimizing treatment for the new patient by taking one of the following actions;

(i) if safety, effectiveness, patient compliance and desirability is more acceptable for the first dose of drug, initiating chronic therapy for the individual human patient using the first dose of drug, taking into account the relative benefits of each dose of drug based on the results of the evaluation of safety, effectiveness, patient compliance and desirability of said first dose of drug and said second dose of said same drug as compared to the patient population database, as well as the relative cost of the first dose of drug and the second dose of the same drug;

(ii) if safety, effectiveness, patient compliance and desirability are more acceptable for the second dose of drug than the first dose of the same drug, initiating chronic therapy for the individual human patient using the second dose of drug;

(iii) if safety, effectiveness, patient compliance and desirability are not more acceptable for either of the first dose of drug and the second dose of the same drug, discontinuing treatment or repeating steps (b)-(d) utilizing new first and second dose of the same drug or a first and a second dose of a second alternative drug, if available; and

, thereafter, if safety, effectiveness, patient compliance and desirability are more acceptable for either the new or the first or second dose of the alternative drug, initiating chronic therapy for the individual human patient using that dose of the drug or second alterative drug.