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Design and Evaluation of Smart Glasses for Food Intake and Physical Activity Classification
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Smart Program Design Through a Common Information Model.

Laszlo Vasko1, Mats Sundgren2, Peter Bachmann3

  • 11 AstraZeneca R&D, Wilmington, DE, USA.

Therapeutic Innovation & Regulatory Science
|September 18, 2018
PubMed
Summary

Clinical program information is unstructured and inconsistent. A new standardized information model is proposed to improve data sharing and decision-making for clinical research programs and trials.

Keywords:
Best practiceClinical program and trial designCollaborationInformation modelSuccess factors

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Area of Science:

  • Biomedical Informatics
  • Clinical Research Informatics
  • Health Data Standards

Background:

  • Current clinical trial data standards do not capture the full scope of clinical program design.
  • Existing information sharing initiatives provide unstructured, inconsistent, and incomplete data on clinical programs.
  • Bioscience companies, healthcare providers, academia, and government agencies need better access to clinical program information.

Purpose of the Study:

  • To propose a standardized information model for clinical programs.
  • To address the limitations of current data standards in capturing program-level objectives and rationale.
  • To facilitate improved information sharing and decision-making in clinical research.

Main Methods:

  • Development of a novel information model focused on clinical program design.
  • Examination of the merits of a clinical program-level information standard by a multicompany working group.
  • Presentation of an example information model to illustrate the proposed concept.

Main Results:

  • Identified a gap in current information standards for clinical program-level data.
  • Proposed an information model to capture the rationalization and decision-making in clinical program design.
  • Demonstrated the feasibility and utility of a program-level information standard through an example.

Conclusions:

  • A standardized information model is crucial for overcoming inconsistencies in clinical program data.
  • The proposed model enhances the capture of program objectives, rationale, and design thinking.
  • Implementing a clinical program-level standard will improve information sharing and support better clinical research decision-making.