Online, interactive evaluation of research performance

• US 8,620,677 B2
• Filed: 04/09/2002
• Issued: 12/31/2013
• Est. Priority Date: 04/09/2002
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: PCRS, Inc.
• Inventors: Blumenfeld, Tracy Harmon
• Primary Examiner(s): Borlinghaus, Jason M
• Assistant Examiner(s): GOTTSCHALK, MARTIN A
• Application Number:
  US10/118,369
• Publication Number:
  US 20030191664A1
• Time in Patent Office: 4,284 Days
• Field of Search: 705/2, 705/3
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/06393 Score-carding, benchmarking or key performance indicator [KPI] analysis
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients
• CPC Class Codes: G16H 70/00 ICT specially adapted for the handling or processing of medical references

Abstract

Medical and other research organizations, sites within those organizations, and physicians practicing at those sites register in an online database. The company providing the database posts a description of a clinical trial opportunity or other research opportunity. The company can search and match for physicians with research opportunities, or the physicians can browse the list of opportunities. Once it is determined who will perform the research and awarded a contract, performance data are collected at 30-day intervals over the life of the trial for computation of benchmarks. The benchmarks from one physician are compared anonymously to those from other physicians participating in the same opportunity.

Claims

1. A system for collecting metrics and calculating and communicating benchmarking information concerning the conduct of a clinical research trial among a plurality of research sites and a plurality of investigators participating in the conduct of said clinical research trial, the system comprising:

a database server for (i) providing a user interface for capturing and displaying investigator and research site metrics for a plurality of research sites and the plurality of investigators who are participating in said clinical research trial, such metrics including at least one of time to first patient enrolled, total patients enrolled after the first 30 days, actual enrollment as a percentage of the enrollment goal, enrollment rate, screen failure rate, completion rate, per-patient budget, number of queries per patient, enrollment as a percentage of patients screened, and elapsed time from irb submission to irb approval, (ii) storing said collected investigator and research site metrics useful at least for calculating benchmarking information regarding the conduct of said clinical research trial; and

(iii) automatically calculating said benchmarking information for each of said plurality of investigators and each of said plurality of clinical research sites participating in said clinical research trial using said collected investigator and research site metrics for said clinical research trial, said benchmarking information comprising information comparing each of said plurality of clinical research sites and each of said plurality of investigators to all clinical research sites and all investigators participating in said clinical research trial; and

a communication server, in communication with said database server, for providing a user interface for communicating some or all of said calculated benchmarking information in real time to one or more of said plurality of investigators and one or more of said plurality of clinical research sites, said calculated benchmarking information being viewable immediately after said investigator and research site metrics are received by said database server.

2. The system of claim 1, wherein the benchmarking information comprises investigator and research metrics continually received by said database server during the clinical research trial.

3. The system of claim 2, wherein the benchmarking information further comprises investigator and research site metrics received by said database server at a beginning of the clinical research trial, throughout the clinical trial, and at an end of the clinical research trial, aggregated for viewing by a sponsor or representatives of a sponsor.

4. The system of claim 2, wherein the benchmarking information further comprises investigator and research site metrics received by said database server at a beginning of the clinical research trial, throughout the clinical trial, and at an end of the clinical research trial.

5. The system of claim 2, wherein the benchmarking information comprises comprise a comparison between the benchmarks of a variety of investigator and research site metrics for the clinical research trial and the benchmarks for other clinical research sites involved in the same clinical research trial.

6. A method for collecting metrics, and calculating and communicating benchmarking information concerning conduct of a clinical research trial among a plurality of research sites and a plurality of investigators participating in the conduct of said clinical research trial, the method comprising the steps of:

(a) providing a user interface for capturing and displaying investigator and research site metrics on a database server for a plurality of research sites and the plurality of investigators who are participating in said clinical research trial, such metrics including at least one of time to first patient enrolled, total patients enrolled after the first 30 days, actual enrollment as a percentage of the enrollment goal, enrollment rate, screen failure rate, completion rate, per-patient budget, number of queries per patient, enrollment as a percentage of patients screened, and elapsed time from irb submission to irb approval;

(b) storing on said database server said collected investigator and research site metrics useful at least for calculating benchmarking information regarding the conduct of said clinical research trial;

(c) automatically calculating on said database server said benchmarking information for each of said plurality of investigators and each of said plurality of clinical research sites participating in said clinical research trial using said collected investigator and research site metrics for said clinical research trial, said benchmarking information comprising information comparing each of said plurality of clinical research sites and each of said plurality of investigators to all clinical research sites and all investigators participating in said clinical research trial; and

(d) providing a user interface for communicating some or all of said calculated benchmarking information in real time to one or more of said plurality of investigators and one or more of said plurality of clinical research sites, said calculated benchmarking information being viewable immediately after said collected investigator and research site metrics are received by said database server.

7. The method of claim 6, wherein said collected investigator and research site metrics stored on said database server comprise metrics received by said database server at multiple times during the clinical research trial in order to update the calculated benchmarking information.

8. The method of claim 7, wherein said collected investigator and research site metrics stored on said database server comprise metrics received at regular time intervals during the clinical research trial updated at any time once the clinical research trial has begun, and wherein updated benchmarking information is viewable automatically as the benchmarking information is updated throughout the duration of the clinical research trial.

9. The method of claim 8, wherein said collected investigator and research site metrics stored on said database server further comprise metrics received at a beginning of the clinical research trial, intervals throughout the clinical research trial, and at an end of the clinical research trial.

10. The method of claim 9, wherein the benchmarking information comprises benchmarks for the regular time intervals.

11. The method of claim 6, wherein the benchmarking information comprises a comparison between the benchmarks of a variety of collected investigator and research site metrics for the clinical research trial of one clinical research site to other clinical research sites involved in the same clinical research trial.

12. The method of claim 8, wherein said collected investigator and research site metrics stored on said database server comprise metrics received at a beginning of the clinical research trial, intervals throughout the clinical research trial, and at an end of the clinical research trial, aggregated for viewing by a sponsor or representatives of a sponsor.