Clinical Trial Complexity Assessment Method
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Solution Overview
Problem
Current tools for planning and cost calculation in clinical trials are labor-intensive, arbitrary, and lack comprehensive methods to account for the complexity drivers of clinical studies, leading to empirical resource allocation and planning processes.
Innovation Solution
A computer-implemented method that assesses and calculates the complexity level of clinical trial studies by identifying key parameters, assigning score values based on a dynamic benchmark, and providing a breakdown of complexity across different pillars, enabling proactive optimization of clinical trial protocols.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If simple Excel-based spreadsheets are used for clinical trial planning, then ease of operation is improved, but measurement precision and reliability of complexity assessment deteriorates
Solution Approach 1:
The patent replaces manual Excel-based calculations with an automated computer-implemented method that systematically evaluates multiple parameters (study size, locations, therapeutic area, drug type, tests, procedures) to calculate complexity levels. This substitution of mechanical manual processes with automated computational algorithms enables both ease of operation through automated scoring and measurement precision through comprehensive parameter coverage and standardized evaluation criteria.
2Measurement precision
If comprehensive assessment of all complexity drivers is implemented, then measurement precision is improved, but device complexity and time required for planning increases
Solution Approach 1:
The patent segments the clinical trial complexity assessment into distinct parameters and pillars (e.g., study size, locations, therapeutic area, drug type, specific tests and procedures). Each parameter is evaluated independently and assigned a complexity level, which are then aggregated to produce an overall complexity score. This segmentation enables comprehensive assessment of all complexity drivers while maintaining manageable structure and reducing perceived system complexity through modular evaluation.
3Productivity
If automated complexity calculation method is implemented, then productivity is improved, but device complexity increases
Solution Approach 1:
The patent creates a universal complexity assessment system that can evaluate different types of clinical trial studies across various therapeutic areas and phases using the same standardized parameters and scoring methodology. This multi-functional approach enables automated calculation for diverse study types without requiring separate evaluation frameworks, thereby improving productivity across the board while the systematic nature of the complexity remains manageable through standardization.
Data Source
AI summary
The present invention relates to a computer-implemented method for assessing and determining a complexity level of at least a portion, or pillar, of a clinical trial study. The method may be implemented by a computing device including at least a processor; a memory and an input and/or output elements. It comprises the steps of selecting and/or defining a clinical trial protocol and, based on the selection and/or definition thereof, activating and/or generating data entries for a set of corresponding parameters correlated to a set-up of the portion of the clinical trial study. The parameters refer to objectives; and/or design; and/or methods; and/or patient assessment procedures and/or patient data collection schedules of the clinical trial study. The method further comprises the steps of automatically assigning a score value to each parameter in the set of parameters; applying statistical rules to the score value of each parameter to obtain a scaled score value; and calculating a complexity level for the portion of clinical trial study, based on the scaled score values of each parameter in the set of parameters.