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Decision support tools for clinical trial design.

S Modgil1, P Hammond

  • 1Department of Biomedical Informatics, Eastman Institute for Oral Health Care Sciences, University College London, 256 Gray's Inn Road, WC1X 8LD, London, UK. s.modgil@eastman.ucl.ac.uk <s.modgil@eastman.ucl.ac.uk>

Artificial Intelligence in Medicine
|March 15, 2003
PubMed
Summary

Poorly designed clinical trials led to the creation of decision support tools for randomized controlled trials. These tools, including Design-a-Trial (DaT), ensure scientifically and ethically sound trial design and protocol generation.

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Area of Science:

  • Clinical Trial Design
  • Medical Informatics
  • Health Research Methodology

Background:

  • Many published clinical trials suffer from poor design, indicating incomplete, disorganized, or erroneous protocols.
  • This highlights a critical need for improved methodologies in clinical trial development.

Purpose of the Study:

  • To introduce a suite of decision support tools designed to aid in the development of robust randomized controlled clinical trials.
  • To detail the theoretical underpinnings and practical application of these novel design tools.

Main Methods:

  • Development of Design-a-Trial (DaT), a core tool that critiques user input to ensure scientific and ethical soundness.
  • Integration of tools for authoring trial plans, featuring macros for common constructs.
  • Implementation of a tool generating solutions to Prolog queries for plan revision based on safety and efficacy requirements.

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Main Results:

  • DaT generates textual protocols and symbolic representations of trial designs.
  • The plan authoring tool facilitates the creation of trial components with reusable macros.
  • The query-based tool offers interactive natural language navigation for plan optimization, yielding symbolic and textual outputs.

Conclusions:

  • The developed decision support tools offer a structured approach to designing scientifically and ethically sound clinical trials.
  • These tools enhance protocol completeness and consistency, addressing common design flaws.
  • The system provides flexibility in generating and refining trial plans and protocols through interactive querying.