System and method for determining site performance

Patent metadata

Field	Value
Publication number	US-2016180276-A1
Application number	US-201514855145-A
Country	US
Kind code	A1
Filing date	Sep 15, 2015
Priority date	Dec 18, 2014
Publication date	Jun 23, 2016
Grant date	—

Abstract

An improved system for determining clinical trial site performance includes a site data filter for separating data corresponding to a clinical trial site into at least one site performance factor category data stream, where each site performance factor category comprises at least one site performance factor and each factor comprises at least one factor choice, a data stream analyzer for analyzing the site performance factor category data stream to determine a factor choice met for each site performance factor and to output a value for the determined factor choice, where the determined factor choice is multiplied by a weighting value, and an aggregator for aggregating the weighted, determined factor choices into a site performance index, where the weighting value is adjusted based on a user's input. An improved method for determining clinical trial site performance is also described and claimed.

First claim

1 . An improved clinical trial site performance calculating system, comprising:
a site data filter configured to separate data corresponding to a clinical trial site into at least one site performance factor category data stream,
each site performance factor category comprising at least one site performance factor,
each factor comprising at least one factor choice;
a data stream analyzer configured to analyze the site performance factor category data stream to determine a factor choice met for each site performance factor and to output a value for the determined factor choice, the determined factor choice being multiplied by a weighting value; and an aggregator for aggregating the weighted, determined factor choices into a site performance index, wherein the weighting value is adjusted based on a user's input.

2 . The improved system of claim 1 , wherein the factor takes into account historic data in addition to clinical trial site data.

3 . The improved system of claim 1 , wherein the factor takes into account demographic data in addition to clinical trial site data.

4 . The improved system of claim 1 , wherein the site performance factor category comprises financial data.

5 . The improved system of claim 4 , wherein the financial site performance factor category comprises a factor comprising a budget percentile.

6 . The improved system of claim 5 , wherein the budget percentile factor choice is at or near the average budget percentile of all sites within the same trial.

7 . The improved system of claim 1 , wherein the site performance factor category comprises subject pool and enrollment history data.

8 . The improved system of claim 7 , wherein the subject pool and enrollment history site performance factor category comprises a percentage achievement of enrollment target factor.

9 . The improved system of claim 8 , wherein the percentage achievement of enrollment target factor choice is between 50% and 90%.

10 . The improved system of claim 1 , wherein all of the weighting values are adjusted.

11 . The improved system of claim 1 , wherein fewer than all of the weighting values are adjusted.

12 . An improved method for calculating clinical trial site performance, comprising:
receiving data from one or more clinical trial sites; associating said clinical trial site data with at least two site performance factors; calculating a weighting value for each site performance factor; calculating at least two factor choices for each site performance factor; analyzing the clinical trial site data and calculating which factor choice is met for each site performance factor; outputting a value for each calculated factor choice; multiplying each calculated factor choice by the weighting value; and generating a site performance index based on aggregating said weighted site performance factor choices.

13 . The improved method of claim 12 , further comprising receiving historic data and generating a site performance index based on the historic data.

14 . The improved method of claim 12 , further comprising filtering said clinical trial site data based on at least one filtering factor.

15 . The improved method of claim 14 , wherein the filtering factor is selected from the type of site, geography of the site, the claimed patient population for a given indication, clinical trial experience, and the specialty of the principal investigator.

16 . The improved method of claim 12 , wherein the generating a site performance index is performed in real time.

17 . The improved method of claim 12 , further comprising
calculating a site performance index for at least two sites; and selecting one of the sites based on the site performance index calculated for each site.

18 . The improved method of claim 17 , wherein filter criteria are used to narrow down site choices.

19 . The improved method of claim 12 , further comprising receiving clinical trials data from publicly and privately supported clinical studies of human participants conducted around the world.

20 . The improved method of claim 12 , further comprising receiving demographic data and generating a site performance index based on the demographic data.

Assignees

• Medidata Solutions Inc

Inventors

• Bound Christopher
• Hartman Joshua
• Piazza Richard

Classifications

• G06Q10/06393 Primary

  Score-carding, benchmarking or key performance indicator [KPI] analysis · CPC title

• G06Q50/22

  Social work or social welfare, e.g. community support activities or counselling services · CPC title

• G06F19/363

  Physics · mapped topic

• G16H10/20

  for electronic clinical trials or questionnaires · CPC title