Method for administering clinical trail material

• US 5,898,586 A
• Filed: 11/04/1994
• Issued: 04/27/1999
• Est. Priority Date: 11/04/1994
• Status: Expired due to Fees

• Current Assignee: Eli Lilly and Company
• Original Assignee: Eli Lilly and Company
• Inventors: Solenberg, James Monroe Jr., Jeatran, Thomas L., Tamura, Roy N.
• Primary Examiner(s): Hayes, Gail O.
• Assistant Examiner(s): Mizrahi, Diane
• Application Number:
  US08/334,411
• Time in Patent Office: 1,635 Days
• Field of Search: 364/413.02, 235/101, 235/375, 705/1
• US Class Current: 705/2
• CPC Class Codes: G06Q 50/22 Social work or social welfare, e.g. community support activities or counselling services
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/13 delivered from dispensers

Abstract

A method for administering clinical trial material includes a method for administering clinical trial material, comprising the steps of providing at least one kit containing a plurality of bottles, each with two separate indicia appearing thereon, at least one of the bottles containing a quantity of clinical material at a first dosage, and another at least one of the bottles containing one of a quantity of the clinical material at a second dosage, a quantity of control drug and a placebo; identifying first and second study groups, each providing a treatment schedule for administering dosages of at least one of the clinical material, the control drug and the placebo, the first and second study groups having different treatment schedules; randomly assigning patients to the first and second study groups; assigning at least one investigator to administer the contents of the plurality of bottles; telephone means accessible to the investigator and having a keypad; providing sponsor computer means including telephony capabilities and for storing information, disseminating information, and instructions over the telephone to the investigators, and for receiving information and instructions over the telephone from the investigators, the computer means operable, upon being contacted by the investigator, to identify which of the plurality of bottle of the kit is to be disseminated to an identified patient, but requiring the investigator to confirm selection of the correct bottle by requesting the investigator to enter into the telephone keypad one of the identifying indicia appearing on the selected bottle; and distributing the at least one kit to said investigator.

Claims

1. A method for administering clinical trial material in a study, comprising the step of:

providing at least one carton containing a plurality of bottles, each bottle having two separate identifying indicia appearing thereon, at least one of said bottles containing a quantity of clinical material at a first dosage, and another at least one of said bottles containing one of a quantity of said clinical material at a second dosage, a quantity of control drug and a placebo and wherein each of said indicia of each of said plurality of bottles is unique within the study;

identifying at last first and second study groups, each having a treatment schedule for administering dosages of at least one of said clinical material, said control drug and said placebo;

randomly assigning patients to said first and second study groups;

assigning at least one investigator to administer the contents of said plurality of bottles to said patients, said investigator having access to telephone means, said telephone means having a keypad and being for inputting and receiving information;

providing sponsor computer means including telephone capabilities and for storing information, for disseminating information and instructions over the telephone to said investigator, and for receiving information and instructions over the telephone from said investigator, said computer means operable, upon being contacted by said investigator, to identify which of said plurality of bottles of said at least one carton is to be administered to an identified one of said patients by reciting one of said two separate identifying indicia appearing on the selected bottle, but requiring said investigator to confirm selection of the correct bottle by requesting the investigator to enter into the telephone keypad the other of said two identifying indicia appearing on the selected bottle; and

distributing said at least one carton to said investigator.

2. The method for administering clinical trial material of claim 1, wherein said first and second study groups have different treatment schedules.

3. The method for administering clinical trial material of claim 1, wherein said providing sponsor computer means step includes said computer being operable to collect information from said investigator over the telephone about a specific patient and to immediately thereafter instruct said investigator which bottle to administer, said instruction of which bottle to administer being based upon the collected information and predetermined study criteria.

4. The method for administering clinical trial material of claim 3, wherein said providing sensor computer means step includes said computer being operable during the course of a study to titrate the dosage of the clinical material it instructs the investigator to administer, said titration being based upon the information received from said investigator and upon predetermined study criteria.

5. The method for administering clinical trial material of claim 3, wherein said providing sponsor computer means step includes said computer being operable during the course of a study to re-randomize the specific patient to one of said at least first and second study groups, said re-randomization being based upon the information received from said investigator and upon predetermined study criteria.

6. The method for administering clinical trial material of claim 3, wherein said providing sponsor computer means step includes said computer being operable during the course of a study to adaptively randomize entry of new patients to one of said study groups in said randomly assigned step, said adaptive randomization being based upon the information received from said investigator and upon predetermined study criteria.

7. The method for administering clinical trial material of claim 6, wherein said providing sponsor computer means step includes said computer being operable to titrate the dosage of the clinical material it instructs the investigator to administer and re-randomize the specific patient to one of said first and second study groups, said titration and re-randomization being based on the information received from said investigator and upon predetermined study criteria, said computer being operable to perform dose titration, re-randomization of patients and adaptive randomization of new patients during an on-going study.

8. The method for administering clinical trial material of claim 6, wherein said providing sponsor computer means step includes said computer being operable during the course of a study to enroll a patient, said patient enrollment being accepted or rejected based upon the information received from said investigator and upon predetermined study criteria.

9. The method for administering clinical trial material of claim 6, wherein said providing sponsor computer means step includes said computer being operable during the course of a study to collect information from and issue instructions to the investigator identifying bad or missing bottles and being operable during the course of a study to direct issuance of replacement bottles therefor.

10. The method for administering clinical trial material of claim 6, wherein said providing sponsor computer means step includes said computer being operable during the course of a study to direct issuance of replacement bottles to an investigator before said investigator runs out of bottles of one of the first dosage, the second dosage, the control drug and the placebo.

11. The method for administering clinical trial material of claim 1 wherein the administering of clinical material is one of double blinding and triple blinding.