HOW PRELIMINARY DATA AFFECT PEOPLES STATED WILLINGNESS TO ENTER A HYPOTHETICAL RANDOMIZED CONTROLLED TRIAL

Purpose: To explore how preliminary trial data affect the general publ ic's stated willingness to enter a randomized clinical trial, Methods: We asked 165 prospective jurors to imagine that their physicians want ed them to enroll in a clinical trial, We then presented them with sce narios portraying preliminary trial results-for example, 9 out of 10 p atients get better with drug A and 5 out of 10 get better with drug B- and asked after each scenario, whether they would choose to be part of the trial. We designed the scenarios to test how stated willingness t o enter the trial would be influenced by: 1) the difference in effecti veness of the 2 treatments based on the patients enrolled thus far; an d 2) by the chance that the difference in effectiveness was random tie , the P value), The subjects' willingness to enter the trial at variou s decision points was analyzed using logistic regression. Results: Few er subjects were willing to enter the trial as preliminary data indica ted either an increasing difference in the effectiveness of the two tr eatments or an increasing statistical significance of that difference, For example 75% of subjects were willing to enter the research trial before any preliminary data were presented, but this number fell to 49 % when subjects were presented with preliminary data showing that 9 ou t of 10 patients improved with one treatment and 5 out of 10 with the other, Multivariable logistic regression revealed that higher P values (odds ratio = 4.29; P < 0.001; 95% CI: 2.22-8.28) and smaller differe nces in effectiveness (odds ratio = 0.02; P < 0.001; 95% CI: 0.00-0.07 ) implicit in preliminary data presented to subjects made subjects les s likely to agree to enter clinical trials. After adjustment for other relevant variables, male gender was associated with increased willing ness to enter the trial. Conclusion: A subjects' willingness to enter the hypothetical trial was influenced by preliminary data, Fewer subje cts were willing to enter the trial as the differences in benefit betw een 2 treatment groups increased, However, the majority of subjects we re willing to enter the hypothetical trial even when preliminary evide nce strongly favored one treatment over another, Given the importance of informed consent in entering patients in clinical trials, these res ults should be confirmed in actual trial settings.