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This study introduces a new tool to streamline clinical trial (CT) protocol design by improving communication between CT sponsors and clinical investigators. The system facilitates feasibility assessments, making CT development more efficient.

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Area of Science:

  • Health Informatics
  • Clinical Trial Management
  • Medical Research Methodology

Background:

  • Clinical trial (CT) protocol design is a complex and time-consuming process.
  • Existing Electronic Health Records for Clinical Research (EHR4CR) platforms aid in patient cohort identification but require improvement in clinician engagement.
  • There is a need for enhanced tools to facilitate input from clinical investigators during protocol design.

Purpose of the Study:

  • To develop and integrate a tool within the EHR4CR platform to improve communication between CT sponsors and clinical investigators.
  • To support the collection of feasibility data for CT protocol design.
  • To streamline the process of obtaining expert input for clinical trial development.

Main Methods:

  • A technical architecture was designed based on specific requirements for feasibility assessments.
  • A system was developed to enable users to generate, send, and complete feasibility questionnaires.
  • The developed system was integrated into the existing EHR4CR platform for multi-site use.
  • Functionality for visualizing the results of feasibility questionnaires was implemented.

Main Results:

  • A novel system was successfully developed and integrated into the EHR4CR platform.
  • The system facilitates direct contact between CT sponsors and clinical investigators.
  • The tool enables efficient generation, distribution, and completion of feasibility questionnaires.
  • Visualization of questionnaire results provides valuable insights for protocol design.

Conclusions:

  • The developed system significantly improves the current methods for clinical trial protocol design.
  • Enhanced communication and streamlined feasibility assessments lead to more efficient CT development.
  • The tool empowers clinical investigators to provide crucial input, optimizing protocol feasibility.