Rationale and protocol for a prospective clinical trial enrollment improvement hybrid study within a trial

Area of Science:

• Clinical research methodology
• Health services research
• Translational science

Background:

• Clinical trial enrollment is a significant challenge, with limited evidence-based strategies for improvement.
• Provider-facing interventions, such as advertising campaigns, show potential but require rigorous evaluation.
• Prospective evaluation of such interventions within clinical trials is lacking.

Purpose of the Study:

• To evaluate the effectiveness of a provider-facing email advertising campaign on clinical trial enrollment.
• To assess implementation outcomes, including email engagement metrics (opens, clicks).
• To refine Study Within a Trial (SWAT) methodologies for evaluating future trial improvement interventions.

Main Methods:

• A randomized clinical trial was designed as a hybrid implementation-effectiveness Study Within a Trial (SWAT).
• The intervention involved a month-long email advertising campaign targeting potential enrollees.
• Effectiveness was measured by enrollment numbers, and implementation by email open and click-through rates.

Main Results:

• Preliminary data indicate the potential effectiveness of email advertising campaigns in enhancing clinical trial recruitment.
• The study established infrastructure for future research on enrollment improvement interventions.
• The protocol serves as a model for evaluating similar enrollment-enhancing strategies.

Conclusions:

• Email advertising campaigns represent a viable strategy for improving clinical trial enrollment rates.
• The Study Within a Trial (SWAT) framework is effective for evaluating interventions aimed at enhancing clinical trial participation.
• This research provides a foundation for future studies and methodological advancements in clinical trial recruitment.