[Consent to enrollment in randomized clinical trials]

Area of Science:

• Oncology
• Clinical Research Methodology
• Health Services Research

Context:

• Multi-facility joint randomized clinical trials are a cornerstone of modern cancer treatment research.
• Variations in patient participation rates across different healthcare facilities can compromise the generalizability of trial findings.
• Understanding participation disparities is crucial for enhancing the validity and applicability of clinical trial outcomes.

Purpose:

• To investigate and compare the participation rates in randomized clinical trials between university hospitals and other general hospitals.
• To identify potential differences in patient willingness to enroll in clinical trials based on hospital type.
• To inform strategies for improving equitable participation in multi-facility clinical research.

Summary:

• A questionnaire-based study anonymously surveyed patients from university hospitals (744 participants) and general hospitals (339 participants).
• Results indicated minimal differences in participation willingness: 10.9% of university hospital patients and 10.6% of general hospital patients expressed willingness to participate.
• Conversely, unwillingness was similar: 28.1% from university hospitals and 27.4% from general hospitals were unwilling.

Impact:

• The study found no significant difference in participation rates between university and general hospitals, challenging assumptions of inherent disparities.
• Findings suggest that efforts to resolve participation differences in multi-facility trials should focus on physician-level factors rather than solely on institutional type.
• This research provides critical insights for optimizing the design and execution of future multi-facility clinical trials to ensure broader applicability and reduce bias.