System and method for evaluating and comparing medical treatments

• US 8,719,051 B2
• Filed: 10/31/2011
• Issued: 05/06/2014
• Est. Priority Date: 01/13/2011
• Status: Expired due to Fees

• Current Assignee: Gear Five Health Solutions Incorporated
• Original Assignee: Gear Five Health Solutions Incorporated
• Inventors: Trifunov, Patricia
• Primary Examiner(s): LAM, ELIZA ANNE
• Application Number:
  US13/286,184
• Publication Number:
  US 20120185266A1
• Time in Patent Office: 918 Days
• Field of Search: 705 2- 3
• US Class Current: 705/2
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

An evaluative software tool to support the assessment of health care-related technologies during development to facilitate making critical decisions for an optimized research, development and commercialization plan is provided. The software tool includes the ability to measure, weight, and integrate the critical factors that come into play in the development of a risk/benefit profile of a technology relative to its competitors, benchmarked around clinical trial measures, in order to determine its development and commercialization success.

Claims

1. A computer-implemented method for evaluating a drug, biologic or medical device in research and development, the method comprising:

using a computerized processor for;

defining a maximum benefit numerical score representing total benefits of a drug, biologic or medical device based on clinical trial data;

defining a maximum risk numerical score representing total risks of the drug, biologic or medical device based on clinical trial data;

receiving identification of a plurality of model categories, wherein the model categories are selected from;

a plurality of medical efficacy and safety categories;

a plurality of value proposition categories; and

a plurality of market dynamics categories;

receiving scaled adjustment values associated with the identified model categories, wherein the scaled adjustment values represent importance of factor elements within a model category;

apportioning the maximum benefit numerical score among the identified model categories based on the scaled adjustment values associated with the model categories;

apportioning the maximum risk numerical score among the identified model categories based on the scaled adjustment values associated with the model categories;

receiving an identification of one or more factor elements defined within one or more of the model categories;

receiving a plurality of risk scores and benefit scores for the identified factor elements;

generating an overall numerical benefit score based on the aggregate of the benefit scores for the identified factor elements as adjusted by the scaled adjustment values associated with the model categories;

generating an overall numerical risk score based on the aggregate of the risk scores for the identified factor elements as adjusted by the scaled adjustment values associated with the model categories;

storing the overall numerical risk and overall numerical benefit scores for the drug, biologic or medical device as separate benefit and risk values in a computerized storage device; and

displaying the stored overall scores on one or more axes.

2. The method of claim 1, wherein a feasibility evaluation is reviewed by a convened panel of relevant category experts in terms of a range of qualitative values ranging from substantially disagree to substantially agree, and incorporating those results as part of the feasibility evaluation.

3. The method of claim 1, wherein the overall numerical risk and overall numerical benefit scores represent a feasibility of the drug, biologic or medical device to meet regulatory approval and achieve commercialization success.

4. The method of claim 1, wherein the adjustment values associated with the model categories comprise one or more multipliers.

5. The method of claim 1, further comprising creating a two-dimensional representation of the overall numerical risk and overall numerical benefit scores.

6. The method of claim 1, wherein the overall numerical risk and overall numerical benefit scores are predictive of commercialization success of the drug, biologic or medical device.

7. The method of claim 1, wherein the overall numerical risk score represents a market risk to a developer of the drug, biologic or medical device.

8. The method of claim 1, further comprising presenting a graphical comparative display of a plurality of drugs, biologics or medical devices in relation to each other in a two dimensional space, wherein a first dimension represents an overall numerical risk and a second dimension represents an overall numerical benefit of each of the drugs, biologics or medical devices.

9. The method of claim 1, further comprising receiving a qualitative descriptor representing quantitative clinical trial data for scoring benefit and risk.

10. The method of claim 9, wherein the qualitative descriptor is selected from a plurality of predefined effectiveness ratings for a drug, biologic or medical device under development.

11. The method of claim 1, wherein each of the model categories further comprises multiple factor elements.

12. The method of claim 1, wherein each of the model categories available for identification is dependent upon the drug, biologic or medical device, and the therapeutic area for which that drug, biologic or medical device is intended.

13. A computer-implemented method for evaluating a drug, biologic or medical device in research and development, the method comprising:

using a computerized processor for;

defining a maximum benefit numerical score representing total benefits of a drug, biologic or medical device based on clinical trial data;

defining a maximum risk numerical score representing total risks of the drug, biologic or medical device based on clinical trial data;

receiving identification of a plurality of model categories, wherein the model categories are selected from;

a plurality of medical efficacy and safety categories;

a plurality of value proposition categories; and

a plurality of market dynamics categories;

apportioning the maximum benefit numerical score among the identified model categories;

apportioning the maximum risk numerical score among the identified model categories;

receiving an identification of one or more factor elements defined within one or more of the model categories;

receiving a plurality of risk scores and benefit scores for the identified factor elements;

receiving scaled adjustment values associated with the identified factor elements, wherein the scaled adjustment values represent the importance of factor elements within a model category;

generating an overall numerical benefit score based on the aggregate of the benefit scores for the identified factor elements as adjusted by the scaled adjustment values associated with the identified factor elements;

generating an overall numerical risk score based on the aggregate of the risk scores for the identified factor elements as adjusted by the scaled adjustment values associated with the identified factor elements;

storing the overall numerical risk and overall numerical benefit scores for the drug, biologic or medical device as separate benefit and risk values in a computerized storage device; and

displaying the stored overall scores on one or more axes.

14. The method of claim 13, wherein a feasibility evaluation is reviewed by a convened panel of relevant category experts in terms of a range of qualitative values ranging from substantially disagree to substantially agree, and incorporating those results as part of the feasibility evaluation.

15. The method of claim 13, wherein the overall numerical risk and overall numerical benefit scores represent a feasibility of the drug, biologic or medical device to meet regulatory approval and achieve commercialization success.

16. The method of claim 13, further comprising presenting a graphical comparative display of a plurality of drugs, biologics or medical devices in relation to each other in a two dimensional space, wherein a first dimension represents an overall numerical risk and a second dimension represents an overall numerical benefit of each of the drugs, biologics or medical devices.

17. A computer system, comprising:

an input device;

an output device;

a processor configured for;

defining a maximum benefit numerical score representing total benefits of a drug, biologic or medical device based on clinical trial data;

defining a maximum risk numerical score representing total risks of the drug, biologic or medical device based on clinical trial data;

receiving identification of a plurality of model categories, wherein the model categories are selected from;

a plurality of medical efficacy and safety categories;

a plurality of value proposition categories; and

a plurality of market dynamics categories;

receiving scaled adjustment values associated with the identified model categories, wherein the scaled adjustment values represent importance of factor elements within a model category;

apportioning the maximum benefit numerical score among the identified model categories based on the scaled adjustment values associated with the model categories;

apportioning the maximum risk numerical score among the identified model categories based on the scaled adjustment values associated with the model categories;

receiving an identification of one or more factor elements defined within one or more of the model categories;

receiving a plurality of risk scores and benefit scores for the identified factor elements;

generating an overall numerical benefit score based on the aggregate of the benefit scores for the identified factor elements as adjusted by the scaled adjustment values associated with the model categories;

generating an overall numerical risk score based on the aggregate of the risk scores for the identified factor elements as adjusted by the scaled adjustment values associated with the model categories;

storing the overall numerical risk and overall numerical benefit scores for the drug, biologic or medical device as separate benefit and risk values in a computerized storage device; and

displaying the stored overall scores on one or more axes.

18. The system of claim 17, wherein the adjustment values associated with the model categories comprise one or more multipliers.

19. The system of claim 17, further comprising creating a two-dimensional representation of the overall numerical risk and overall numerical benefit scores.

20. The system of claim 17, wherein the overall numerical risk and overall numerical benefit scores are predictive of commercialization success of the drug, biologic or medical device.