Should You Allow Participants to Pause Their Involvement?

Some participants fall behind. Life gets in the way... work stress, caregiving, illness and many other unpredictable things that crop-up. And in a decentralised trial, it is easier for people to drift. But instead of counting that as attrition, what if the protocol allowed for a pause?

This post explores that question from operational, ethical, and data quality perspectives:

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The Reality of Partial Participation

People often want to stay in a study, they just cannot keep up for a few days or weeks. Without a pause option, the only choices are full withdrawal or informal noncompliance. Neither is great for the study, and both feel rigid.

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What a Pause Could Look Like

• Participant marks themselves “on hold” in the app
• Site staff enter a pause code in the CRF
• Data collection tools temporarily stop sending prompts
• Participant is recontacted after a set interval

This is not a dropout, it is a documented pause. I.e. A scheduled gap, a structured option etc.

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Benefits

• Retains participants who might otherwise leave permanently
• Improves data integrity by distinguishing missed data from exited status
• Builds trust by respecting participants’ situations
• Gives study teams flexibility without rewriting the whole protocol

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Concerns to Address

• Re-engagement might not succeed
• Risk of introducing bias if pause use is uneven across groups
• Statistical methods must account for these windows in analysis
• Study timelines may stretch slightly if many pauses occur

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Where This Works Best

• Longitudinal studies (especially behavioral or nutritional)
• Minimal-risk interventions
• App-based trials where prompts are frequent

In short, any context where life interruptions are expected, and where a pause can preserve more data than it costs.

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Implementation Considerations

• Define maximum pause duration
• Limit how often pauses can be used
• Create standard language in consent forms
• Flag re-onboarding tasks if protocol requires them

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It is a new mindset: design for continuity, not just completion.

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