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Trial informativeness across research practices: initial findings from a mapping exercise.

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Summary

This study identified 12 good practice actions to improve trial informativeness across design, conduct, and knowledge mobilization. These actions involve multiple stakeholders and aim to enhance research systems for better clinical trial quality.

Keywords:
Clinical trial designEvidence mappingKnowledge mobilizationResearch systemsTrial conductTrial informativeness

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Area of Science:

  • Clinical Research
  • Health Systems Research
  • Trial Informativeness

Background:

  • Trial informativeness is affected by interconnected factors in design, conduct, and knowledge mobilization.
  • Current research practices' alignment of these factors is unclear.
  • This study clarifies shared processes for informative trials and research systems.

Purpose of the Study:

  • To identify areas of convergence across three research strands related to trial informativeness.
  • To clarify shared processes and actions underpinning informative trials.
  • To understand the broader research systems influencing trial quality.

Main Methods:

  • A mapping exercise comparing a rapid review of global insights, content analysis of clinical trial guidance, and qualitative interviews.
  • Extraction and organization of verbatim or conceptually similar actions to improve trial informativeness.
  • Synthesis of supporting descriptors to capture consistent learnings across evidence sources.

Main Results:

  • Identified 12 good practice actions spanning trial design, conduct, and knowledge mobilization.
  • These actions reflect consistent priorities across evidence, guidance, and stakeholder perspectives.
  • Implementation involves multiple actors, including funders, sponsors, investigators, and regulatory authorities.

Conclusions:

  • The 12 good practice actions strengthen research systems for informative trials.
  • These actions address broad drivers of trial quality within and beyond individual studies.
  • Future work should focus on applying, evaluating, and refining these actions in diverse settings.