Participant Recruitment in Decentralized Studies: Design, Execution, and Scale on Alethios

Participant recruitment is consistently cited as one of the primary drivers of delay, cost overruns, and early termination in clinical and real-world research. Estimates suggest that up to 80% of clinical trials fail to meet their original enrollment timelines, and approximately 20–30% of trials are terminated early due to insufficient recruitment (Suliman et al., 2019; Carlisle et al., 2015).

As trials have increasingly moved into decentralized and hybrid formats, recruitment has shifted toward digital and social media–based approaches. While these channels can dramatically expand reach, they also introduce new challenges: poorly matched participants, higher early attrition, inconsistent eligibility enforcement, and fragmented study infrastructure (Boger et al., 2022; Topol, 2019).

Alethios was designed with these realities in mind. Recruitment is not treated as a downstream marketing activity, but as an integral component of study execution—governed by the same systems that manage screening, consent, onboarding, and longitudinal participation.

Recruitment Begins With Eligibility Enforcement

Across all studies on Alethios, recruitment is anchored by a structured screening questionnaire that is enforced before consent.

Key characteristics of screening on Alethios include:

• Question-level inclusion and exclusion logic
  
  
• Eligibility determination prior to consent presentation
  
  
• Support for automatic eligibility or manual participant review
  
  
• Prevention of duplicate enrollment and questionnaire “gaming”
  
  
• Exclusive enrollment rules across concurrent studies
  
  
• Configurable washout periods for members of the Alethiad Participant Community
  
  

These screening mechanisms are system-level requirements. They apply uniformly regardless of how participants are sourced and are designed to preserve population integrity at scale.

For studies that are made available to the Alethiad Participant Community, Alethios also develops participant-facing landing pages aligned with the screening logic. These pages translate eligibility criteria, study expectations, and incentives into clear, compliant language, reducing early attrition and improving eligibility matching before consent.

Recruitment Models Supported by Alethios

Once eligibility criteria are finalized, researchers select how participants are sourced. Alethios supports three recruitment models. All participants, regardless of source, enter the same screening, consent, onboarding, and study execution workflows.

Self-Service Recruitment

Self-service recruitment is appropriate for teams that wish to control distribution while relying on Alethios for infrastructure and execution.

In this model:

• Screening, consent, onboarding, and study execution occur entirely within Alethios
  
  
• Researchers may use Alethios’ recruitment tools to generate compliant assets, or
  
  
• Researchers may direct traffic through their own channels (email lists, communities, social platforms, partner referrals)
  
  

Alethios’ AI-assisted recruitment framework generates image-based ads, captions, and flyers based directly on the study configuration, including eligibility criteria, incentives, onboarding steps, and study schedules. This allows teams to deploy consistent, compliant materials without duplicating work or paying for recruitment services they do not require.

External Partner Recruitment

Some studies require specialized populations or benefit from established third-party recruitment relationships. Alethios supports this model without fragmenting execution.

In this model:

• External partners direct prospective participants to Alethios
  
  
• All screening, eligibility determination, consent, and onboarding occur within the platform
  
  
• Eligibility logic and participant data remain centralized
  
  

This preserves consistency and auditability while allowing flexibility in sourcing.

Alethiad Participant Community Recruitment

For teams prioritizing speed and operational simplicity, Alethios offers recruitment through the Alethiad Participant Community.

In this model, Alethios:

• Develops customized recruitment assets aligned with the study design
  
  
• Generates large volumes of creative variations to prevent ad fatigue
  
  
• Runs paid digital campaigns and/or targeted email outreach
  
  
• Engages the Alethiad Participant Community directly
  
  
• Packages and submits recruitment materials for IRB review
  
  
• Launches recruitment on timelines measured in days rather than weeks
  
  

Participants recruited through the Alethiad Participant Community follow the same screening, consent, onboarding, and study execution workflows as all other participants.

Why Recruitment Timelines Are Shorter on Alethios

Faster recruitment on Alethios reflects architectural choices rather than relaxed standards.

Contributing factors include:

• Early eligibility filtering prior to consent
  
  
• Participant-facing explanations grounded in actual study configuration
  
  
• AI-assisted asset generation informed by prior recruitment performance
  
  
• Centralized enforcement of eligibility criteria across all sources
  
  
• Rapid iteration on messaging without modifying study logic
  
  

By aligning recruitment design with study execution, Alethios reduces mismatches between participant expectations and study requirements—one of the most common sources of early dropout in decentralized trials (Boger et al., 2022).

Recruitment as a Structural Component of Study Design

On Alethios, recruitment is not an isolated workflow. It is a structural component of study design.

Eligibility criteria, participant communication, and execution logic are defined once and enforced consistently across all recruitment pathways. This approach supports faster enrollment while maintaining population integrity, auditability, and reproducibility.

References

Carlisle B, Kimmelman J, Ramsay T, MacKinnon N. Unsuccessful trial accrual and human subjects protections: An empirical analysis of recently closed trials. Clinical Trials. 2015.

Suliman S, et al. Challenges and solutions in clinical trial recruitment. Contemporary Clinical Trials Communications. 2019.

Boger E, et al. Patient recruitment and retention in decentralized clinical trials. NPJ Digital Medicine. 2022.

Topol EJ. High-performance medicine: the convergence of human and artificial intelligence. Nature Medicine. 2019.