Clinical Trial Site Selection via Automated Data Merging

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Solution Overview

Problem

The process of selecting clinical trial sites and principal investigators is cumbersome due to the scattered nature of data, lack of standardized ranking methodologies, and difficulty in uncovering meaningful information, leading to inefficiencies in clinical trial operations.

Innovation Solution

A computer-implemented method that retrieves clinical trial records, maps them to payment records, merges the data, estimates imputed enrollees, aggregates ranking factors, determines scores, and generates visual representations to facilitate site and investigator selection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional manual site selection methods are used, then thorough evaluation of site capabilities can be conducted, but the process requires considerable time and manual effort

Engineering Contradiction:

Improvesite evaluation accuracyVSAvoidsite selection time

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The patent replaces manual mechanical evaluation processes with automated computer-based systems that retrieve, map, merge, and analyze clinical trial and payment data automatically, eliminating the need for manual data collection and site assessment while maintaining evaluation accuracy

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces an intermediary computational system that acts as a bridge between scattered data sources and decision-makers, automatically mapping clinical trial records to payment records and generating standardized site rankings and visualizations that would otherwise require extensive manual analysis

Inventive Principle:

Principle #24Intermediary (Mediator)

2Loss of information

If data is collected from various scattered sources, then comprehensive information can be obtained, but the data becomes difficult to access and analyze

Engineering Contradiction:

Improvedata completenessVSAvoiddata accessibility

Core Design Contradiction:

Loss of informationVSEase of operation

Solution Approach 1:

The patent merges scattered clinical trial data and payment data from multiple sources into a unified dataset by automatically mapping records through shared identification aspects, enabling comprehensive analysis while improving data accessibility through centralized processing

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent introduces an intermediary data mapping and merging system that connects disparate data sources, automatically matching clinical trial records with payment records through shared identifiers and generating unified, easily accessible datasets for analysis

Inventive Principle:

Principle #24Intermediary (Mediator)

3Adaptability or versatility

If no standardized ranking methodology is used, then flexible site assessment can be performed, but meaningful data comparison becomes difficult

Engineering Contradiction:

Improveassessment flexibilityVSAvoiddata comparability

Core Design Contradiction:

Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The patent transforms unstandardized site assessment data into standardized comparable metrics by calculating enrollment rates, payment efficiencies, and composite scores that enable precise comparison across different sites while maintaining the ability to assess various site characteristics

Inventive Principle:

Principle #35Parameter changes

4Measurement precision

If manual site selection process is used, then detailed site capabilities can be evaluated, but the overall productivity of clinical trial operations decreases

Engineering Contradiction:

Improvesite evaluation thoroughnessVSAvoidclinical trial operation efficiency

Core Design Contradiction:

Measurement precisionVSProductivity

Solution Approach 1:

The patent replaces manual site selection processes with automated computer-based systems that rapidly retrieve, map, merge, and analyze data from multiple sources, generating standardized rankings and visualizations that maintain evaluation thoroughness while dramatically improving operational efficiency

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent performs preliminary automated data retrieval, mapping, merging, and analysis before site selection decisions are made, preparing standardized rankings and visualizations in advance that enable faster, more informed decision-making without sacrificing evaluation quality

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS20240355433A1Clinical trial site selection and interactive visualization

Publication Date: 2024.10.24 SUMITOVANT BIOPHARMA INC

AI summary

A method comprising retrieving a plurality of clinical trial records from a clinical trial database; mapping each of the plurality of clinical trial records to one or more of a plurality of payment records from a payment database, manifesting a set of mapped records; merging each of the plurality of clinical trial records with the one or more of the plurality of payment records based on the set of mapped records, forming a merged dataset comprising a plurality of merged data entries; estimating imputed enrollees for each of the merged data entries; determining a ranking for each of the one or more ranking factors for each of the merged data entries; determining a score for each of the merged data entries based on the rankings; and generating a visualizer based on at least the score for each of the merged data entries.