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Thoughtflow: Standards and Tools for Provenance Capture and Workflow Definition to Support Model-Informed Drug

J J Wilkins¹, Pls Chan², J Chard³

¹Occams, Amstelveen, The Netherlands.

CPT: Pharmacometrics & Systems Pharmacology

|May 16, 2017

Summary

Automating pharmacometric analysis documentation with the proposed "Thoughtflow" standard streamlines data management. This enhances reproducibility and decision-making in model-informed drug discovery and development.

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Area of Science:

Pharmacometrics
Computational Biology
Drug Development

Background:

Pharmacometric analyses generate vast, complex data requiring meticulous tracking for regulatory compliance and quality control.
Current manual documentation processes are time-consuming, error-prone, and divert scientific resources.
Reproducibility and knowledge transfer are critical challenges in model-informed drug discovery and development (MID3).

Purpose of the Study:

To propose a standardized approach for capturing, storing, and reporting knowledge in pharmacometric analyses.
To introduce "Thoughtflow," an open standard designed to facilitate documentation and enhance reproducibility.
To provide a prototype software implementation of the proposed standard.

Main Methods:

Development of the "Thoughtflow" standard by the Innovative Medicines Initiative (IMI) Drug Disease Model Resources (DDMoRe) consortium.
Focus on capturing and linking data, metadata, assumptions, and decisions within pharmacometric analyses.
Creation of a prototype software tool to demonstrate the practical application of the standard.

Main Results:

A proposed set of standards ("Thoughtflow") for comprehensive documentation of pharmacometric analyses.
Demonstration of how "Thoughtflow" can support knowledge capture, storage, and reporting.
A prototype software implementation illustrating the practical application of the "Thoughtflow" standard.

Conclusions:

Automating the documentation of pharmacometric analyses using "Thoughtflow" can save time and reduce errors.
The proposed standard supports reproducibility, knowledge retention, and good practice in MID3.
"Thoughtflow" offers a pathway to ensure pharmacometric analyses effectively inform critical decisions.