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Helping Participants Access Aggregate Study Results

Participants may want to know what a study learned without knowing where or when results will be available.

Representative research photograph: Helping Participants Access Aggregate Study Results
Photo: U.S. Army photo by 1st Lt. Katherine Sibilla · License: Public domain · Cropped and resized.
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Participants may want to know what a study learned without knowing where or when results will be available. A results-access plan should distinguish aggregate findings from individual clinical results. Overall study findings should not be presented as a personal health assessment.

Define the workflow

The site can explain how to reach available approved results information. Avoid promising publication dates or personal benefit. Consider links, translations, accessible formats and question-routing. If contact information is used for results sharing, clarify that scope through the appropriate study arrangements.

Worked example

For example, a completed trial publishes a lay summary. Staff provide the approved access route and explain that it describes results across study groups. Questions about the individual’s treatment response or future care go to an appropriate clinical discussion, rather than being interpreted independently by the coordinator.

Practical checks

  • Clearly distinguish an aggregate summary from individual measurements or treatment information.
  • Confirm that a shared link points to the correct study and appropriate language version.
  • Establish separate routes for scientific questions and questions about personal clinical care.

Decision and boundaries

A good plan supports access and honestly describes the limits of available answers. If results are not published, do not invent a definite date; explain the current situation using appropriate information. Respect communication preferences and privacy. Responsibility for preparing and publishing the summary is distinct from a site’s role in helping people find it.

Frequently asked questions

Do aggregate results show personal treatment response?
No. A group-level finding is different from one individual’s result or a decision about their future care.
What if the publication date is unknown?
Explain the current situation without unverified dates or guarantees, and identify an appropriate channel for future information.

Sources

  1. EMA — ICH E6 Good Clinical Practice
  2. WHO — Guidance for best practices for clinical trials