Clinical Scorecard: Empowerment through Representation: Outcomes of Traditional, Hybrid, and Digital Recruitment Methods in a Non-Randomized Clinical Trial Involving Adolescents

At a Glance

Key Highlights

• Digital recruitment accounted for the largest proportion of enrolled participants (39.1%), followed by traditional (34.2%) and targeted hybrid (23.2%) methods.
• Targeted hybrid recruitment, despite lower enrollment numbers, achieved the highest inclusion of historically underrepresented groups (87.5%) compared to traditional (48.5%) and digital (32.3%) methods.
• Multipronged recruitment approaches with quota sampling can enhance inclusivity and population representativeness in clinical trials involving adolescents and young adults.

Guideline-Based Recommendations

Diagnosis

• Not applicable – study focuses on recruitment strategies rather than diagnosis.

Management

• Implement multipronged recruitment strategies combining traditional, hybrid, and digital methods to improve diversity and representativeness in clinical trial enrollment.

Monitoring & Follow-up

• Use quota sampling to balance enrollment by age, gender, race, and ethnicity to monitor and ensure population representativeness.

Risks

• Be aware of potential digital divide and ethical concerns in fully decentralized trials that may limit access for some populations.
• Address mistrust, health literacy, and access barriers that contribute to underrepresentation in clinical research.

Patient & Prescribing Data

Adolescents aged 13–17 and young adults aged 18–21 participating in genomic research trials

Recruitment via targeted hybrid methods (letters and text messages) is effective for enrolling participants from historically underrepresented groups, supporting equitable trial participation.

Clinical Best Practices

• Combine traditional, hybrid, and digital recruitment methods to maximize enrollment and inclusivity.
• Apply quota sampling to ensure demographic balance reflective of the target population.
• Engage community advocates and use institutional resources to support outreach efforts.
• Report social determinants of health data comprehensively to assess inclusivity and representativeness.
• Consider ethical implications and access barriers when designing decentralized or digital recruitment strategies.

References

• ClinicalTrials.gov - Engaging Adolescents in Decisions about Return of Genomic Research Results (EAS) Trial
• Healthy People 2030 Initiative
• Coss et al. SDoH Guidelines for DHT-enabled Clinical Research