System and method for determining a clinical trial patient burden

Patent metadata

Field	Value
Publication number	US-2016203296-A1
Application number	US-201514857373-A
Country	US
Kind code	A1
Filing date	Sep 17, 2015
Priority date	Jan 14, 2015
Publication date	Jul 14, 2016
Grant date	—

Abstract

An improved clinical trial patient burden calculating system includes a data analyzer to calculate scores and weights for patient burden components, a plurality of data calculators to calculate a respective plurality of sub patient burden indexes based on the patient burden component scores and weights, and an aggregator to calculate a procedure-level patient burden index based on aggregation of the sub patient burden indexes. An improved method for calculating clinical trial patient burden is also described and claimed.

First claim

1 . An improved clinical trial patient burden calculating system, comprising:
a data analyzer configured to calculate scores and weights for patient burden components; a plurality of data calculators configured to calculate a respective plurality of sub patient burden indexes based on the patient burden component scores and weights; and an aggregator configured to calculate a procedure-level patient burden index based on aggregation of the sub patient burden indexes.

2 . The improved system of claim 1 , further comprising a data filter configured to separate aggregated patient burden component scores and weights into component scores and weights.

3 . The improved system of claim 1 , wherein the patient burden components include invasiveness, pain, time, and privacy.

4 . The improved system of claim 3 , wherein the patient burden components include harmful exposure and location.

5 . The improved system of claim 1 , wherein the data analyzer is configured to determine clinical trial procedures based on clinical trial protocol design data.

6 . The improved system of claim 1 , wherein the data analyzer is configured to determine patient burden components based on clinical trial protocol design data.

7 . The improved system of claim 1 , further comprising a second aggregator configured to aggregate procedure-level patient burden indexes into a trial-level patient burden index.

8 . The improved system of claim 1 , wherein the data analyzer is configured to use feedback to calculate scores and weights for patient burden components.

9 . The improved system of claim 1 , wherein the aggregator calculates the procedure-level patient burden index by summing together the sub patient burden indexes.

10 . An improved method for calculating clinical trial patient burden, comprising:
receiving protocol design data from one or more clinical trial designs, the designs including at least one clinical trial procedure; determining patient burden components of said at least one clinical trial procedure; analyzing the burden components; calculating a score and a weight for at least two burden components; and calculating a procedure-level patient burden index based on a weighted score.

11 . The method of claim 10 , further comprising receiving industry data and calculating the procedure-level patient burden index based on the industry data.

12 . The method of claim 10 , further comprising receiving user input data and calculating the procedure-level patient burden index based on the user input data.

13 . The method of claim 12 , wherein the user input data comprises an age of a clinical trial patient and the age is used to calculate an adjustment factor for the score, the weight, or both.

14 . The method of claim 12 , wherein the user input data comprises an age of a clinical trial patient and the age is used to calculate the score, the weight, or both.

15 . The method of claim 10 , further comprising receiving survey data and calculating the procedure-level patient burden index based on the survey data.

16 . The method of claim 15 , wherein the survey data comprises patient-generated data received via a wearable, implantable, or ingestible device.

17 . The method of claim 10 , further comprising:
calculating a procedure-level patient burden index for each of a plurality of procedures; and calculating a trial-level patient burden index by aggregating said procedure-level patient burden indexes.

Assignees

• Medidata Solutions Inc

Inventors

• Bound Christopher
• Hartman Joshua
• Marlborough Michelle
• Zielinski Anne
• Mcnierney David
• Campo Rafael

Classifications

• G16H10/20

  for electronic clinical trials or questionnaires · CPC title

• G16H50/20 Primary

  for computer-aided diagnosis, e.g. based on medical expert systems · CPC title

• G06F19/363 Primary

  Physics · mapped topic

• G06F19/345

  Physics · mapped topic