Transforming patient recruitment in clinical trials: Communication training to manage uncertainties about risks and benefits.

Abstract

Purpose: Effective communication of risks and benefits is essential to ethical clinical trial recruitment, yet clinical research coordinators (CRCs) often lack formal training in how to navigate participant uncertainty. This study examined whether targeted communication training could enhance CRCs' ability to disclose risks and benefits clearly and ethically.

Approach or design: A mixed-methods, pre-post design compared CRCs who received communication training with those in a control group.

Setting: Standardized patient (SP) interactions simulating clinical trial recruitment conversations.

Participants: Twenty-four CRCs participated across intervention and control groups.

Intervention: A communication training program grounded, focusing on transparent disclosure, benefit framing, and participant engagement strategies.

Method: Qualitative content analysis of SP interaction transcripts guided by uncertainty management theory examined risk disclosure, mitigation strategies, benefit framing, and engagement. Frequency analysis tracked changes in the number and specificity of risk/benefit mentions over time.

Results: CRCs in the intervention group demonstrated more structured and transparent risk disclosure, greater use of participant-centered benefit framing, and improved interpersonal engagement. Frequency analysis showed significant increases in both the number and specificity of risk and benefit mentions post-training. Control group CRCs showed minimal change.

Conclusion: Targeted communication training enhances CRCs' ability to manage participant uncertainty, improving both ethical standards and informed consent quality in clinical trial recruitment.