How preliminary data affect people's stated willingness to enter a hypothetical randomized controlled trial

Area of Science:

• Clinical Research
• Biostatistics
• Behavioral Science

Background:

• Informed consent is crucial for ethical clinical trial participation.
• Understanding public perception of preliminary trial data is essential for recruitment.

Purpose of the Study:

• To assess how preliminary clinical trial results affect the public's willingness to enroll.
• To investigate the impact of treatment effectiveness differences and statistical significance on trial participation decisions.

Main Methods:

• 165 prospective jurors were presented with hypothetical clinical trial scenarios.
• Scenarios varied treatment effectiveness (e.g., 9/10 vs. 5/10) and statistical significance (P value).
• Participant willingness to enroll was analyzed using logistic regression.

Main Results:

• Willingness to enroll decreased with larger treatment effectiveness differences and higher statistical significance (P values).
• For instance, willingness dropped from 75% to 49% with specific preliminary data.
• Higher P values (OR=4.29) and smaller effectiveness differences (OR=0.02) reduced enrollment likelihood; male gender increased willingness.

Conclusions:

• Preliminary data significantly impact willingness to join clinical trials.
• Despite this, a majority remained willing even with strong preliminary evidence favoring one treatment.
• Further validation in actual trial settings is recommended to refine informed consent processes.