SYSTEM AND METHOD FOR FACILITATING CENTRALIZED CANDIDATE SELECTION AND MONITORING SUBJECT PARTICIPATION IN CLINICAL TRIAL STUDIES

• US 20100100397A1
• Filed: 12/21/2009
• Published: 04/22/2010
• Est. Priority Date: 08/14/2003
• Status: Abandoned Application

• Current Assignee: MedAvante, Inc. (WCG Clinical, Inc.)
• Original Assignee: MedAvante, Inc. (WCG Clinical, Inc.)
• Inventors: Gilbert, Paul Michael, Kane, John Michael, Johnson, Livingston
• Application Number:
  US12/643,594
• Publication Number:
  US 20100100397A1
• Time in Patent Office: Days
• US Class Current: 705/3
• 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: G06Q 30/0203 Market surveys; Market polls
• CPC Class Codes: G06Q 99/00 Subject matter not provided for in other groups of this subclass
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage

Abstract

A system and method of facilitating centralized and standardized remote ratings of subjects in clinical trial studies includes providing training to raters located at one or more central rating sites such that the raters are trained to apply substantially similar criteria in determining whether a candidate is a qualified subject for the clinical trial and/or in the actual assessment, or information collection, phase of the clinical trail. By having centralized, consistently trained raters that are independent of clinical trial investigators, inter-rater reliability is enhanced and potential bias is reduced, thus increasing the effectiveness of the clinical trial results by providing more qualified subjects and more accurate results.

Claims

1. A method for conducting a clinical trial on a medicament which trial comprises at least one efficacy parameter that is subjective based on clinical judgment, comprising:

(a) training raters located at least one centralized site, remote from the site(s) at which the clinical trial study is conducted, such training involving having the raters apply substantially similar criteria for enrolling patients into the study based on said subjective parameter;

(b) enrolling patients into the study where the raters remotely gather information about the patients so that those patients that satisfy said criteria can be ascertained,

(c) assigning some patients who satisfy said criteria to a treatment comprising said medicament and assigning other patients who satisfy said criteria to a placebo in lieu of treatment with said medicament;

(d) treating patients with either medicament or placebo as the case may be for a treatment period;

(e) after the treatment period is over, having the trained raters remotely gather information from the patients so that it can be evaluated whether the patients receiving medicament are different in relation to said subjective efficacy parameter compared to patients receiving placebo; and

(f) evaluating whether the patients receiving medicament are different in relation to said subjective efficacy parameter compared to patients receiving placebo.

2. The method of claim 1 wherein the raters gather information on said patients over at least one communications link.

3. The method of claim 2 wherein a clinical trial sponsor or investigator performs step (d).

4. The method of claim 2 wherein a clinical trial sponsor or investigator performs step (f).

5. The method of claim 2 wherein a clinical trial sponsor or investigator performs step (c).