# US 2013/0159010 A1 · Endpoint development process

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- Number: US 2013/0159010 A1
- Document ID: US20130159010A1
- Status: Published application
- Kind: A1
- Application number: 13/670,151
- Filed: 2012-11-06
- Published: 2013-06-20
- Earliest claimed: 2008-07-25
- Assignees: eResearchTechnology, Inc.
- Inventors: Jean Paty; Alan Shields; Chad Gwaltney; Brian Tiplady
- Web page: https://patentgrep.com/patent/US20130159010A1

## CPC

- G16H 10/20: for electronic clinical trials or questionnaires
- G06Q 10/00: Administration; Management
- G06Q 30/0203: Market surveys; Market polls
- G16Z 99/00: Subject matter not provided for in other main groups of this subclass
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G06Q: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
- G16Z: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR

## Abstract

A system for developing and producing clinical endpoints based on patient reported outcome data utilizing algorithms to generate decision rules to evaluate patient reported outcome type questionnaire is provided. The questionnaires can include health-related quality of life questionnaires and can predict the reliability of endpoints in supporting one or more medical labeling claims.

## Claims

### Claim at position 1

-18. (canceled)

### Claim 19

A method of developing a questionnaire for use in a clinical trial comprising:
a. administering one or more questions to a subject who is administered a medical product or a placebo and recording said subject's response to said one or more questions as a first set of data;
b. analyzing said first set of data to determine validity or reliability of said one or more questions;
c. accepting said one or more questions for collection in step d), or modifying said one or more questions and providing it again in step a);
d. collecting said one or more questions into a questionnaire;
e. administering said questionnaire to a subject in a clinical trial, wherein said administering is by a portable electronic device, wherein said portable electronic device records said subject in a clinical trial's response as a second set of data; and
f. analyzing said second set of data to determine if a pre-determined clinical trial endpoint has been reached in said clinical trial.

### Claim 20 (depends on 19)

The method of claim 19, wherein said questionnaire comprises one or more health-related quality of life (HRQOL) questions.

### Claim 21 (depends on 19)

The method of claim 19, wherein step b) comprises analyzing said data for one or more evaluative indicators.

### Claim 22 (depends on 19)

The method of claim 19, wherein said first or second set of data comprises patient-reported outcome (PRO) data or metadata.

### Claim at position 6

23-30. (canceled)

### Claim 31

A computer program product comprising a computer readable medium having computer program logic encoded thereon for enabling a processor to develop a questionnaire for use in a clinical trial comprising:
a. a receiving procedure that enables a processor to receive data from a portable electronic device, wherein said data comprises a response to one or more questions responded to by a subject who was administered a medical product or a placebo;
b. an analyzing procedure to analyze said data to determine validity or reliability of said one or more questions, wherein said analyzing procedure collects a question determined to be valid or reliable and outputs for use in a clinical trial questionnaire or said analyzing procedure modifies a question determined to be invalid or unreliable and outputs it for administration to said subject who is administered a medical product or a placebo; and
c. an output procedure to provide a validated or reliable question for use in a clinical trial or to provide a modified question to said subject who is administered a medical product or a placebo.

### Claim 32 (depends on 31)

The computer program product of claim 31, wherein step b) comprises analyzing said data for one or more evaluative indicators.

### Claim 33 (depends on 31)

The computer program product of claim 31, wherein said data comprises PRO data or metadata.

### Claim at position 10

-35. (canceled)