Can response-adaptive randomization increase participation in acute stroke trials?

Area of Science:

• Clinical Trials
• Biostatistics
• Medical Research

Background:

• Response-adaptive randomization (RAR) trials dynamically adjust participant allocation to favor better-performing treatments.
• RAR designs offer potential advantages over standard clinical trials, particularly for improving patient participation in acute stroke studies.

Purpose of the Study:

• To evaluate patient willingness to enroll in a hypothetical acute stroke trial using response-adaptive randomization versus a standard trial design.
• To assess the impact of RAR on research participation rates and patient understanding.

Main Methods:

• A cross-sectional randomized survey of 418 adult emergency department patients (age ≥18) without acute conditions.
• Participants were randomized to view information on either an RAR or a standard hypothetical acute stroke trial.
• A multivariable logistic regression model analyzed consent rates, controlling for demographics and understanding.

Main Results:

• Participation was significantly higher in the RAR trial (67.3%) compared to the standard trial (54.5%), an absolute increase of 12.8%.
• The RAR group showed a higher odds ratio for agreeing to participate (OR, 1.89), indicating increased willingness to join research.
• Participants generally understood both trial designs well.

Conclusions:

• Hypothetical response-adaptive randomization trials demonstrated greater appeal to research participants than standard randomization.
• RAR designs hold significant potential for enhancing patient recruitment and benefiting future clinical trial participants, especially in acute stroke research.