Transparency in the presentation of trial results may not increase patients' trust in medical researchers.

BACKGROUND: One of the expected benefits of sharing trial results with participants is that it may enhance trust in medical researchers (TMRs). PURPOSE: In a prospective study on a sample of clinical trial participants, we investigated the effect on the participants' TMRs of providing final trial results to participants via the Internet. METHODS: Participants in the FNCLCC-PACS04 trial (ClinicalTrials.gov Identifier: NCT00054587) were surveyed on average 6 years after enrollment, when the trial results were available. In the current study, they were randomized to receive (experimental group) or not to receive (control group) a letter informing them that the results of the trial could be consulted on a specific website. TMRs was measured before randomization and 6 months later using mailed self-administered questionnaires. RESULTS: The response rate was 93% (N = 107). TMRs remained unchanged in the control group (mean effect size = -0.06, 95% confidence interval (CI): -0.28 to 0.17, p = 0.617) but decreased in the experimental group (-0.30, 95% CI: -0.53 to -0.06, p = 0.015). However, the difference between the two effect sizes was not statistically significant (p = 0.144). LIMITATIONS: The results obtained here on the disclosure of final trial results to breast cancer patients via the Internet cannot be generalized to all situations involving the disclosure of phase III randomized controlled trial results. CONCLUSIONS: Transparency is an ethical research requirement, but it may not enhance participants' TMRs.

Patients' regrets after participating in a randomized controlled trials depended on their involvement in the decision making.

OBJECTIVE: To identify the factors associated with long-term regrets expressed a posteriori by randomized controlled trial (RCT) participants questioned about their decision to participate in an RCT. STUDY DESIGN AND SETTING: Participants were questioned 6 years on average after their inclusion in a breast cancer adjuvant therapy RCT. Among 115 women from 21 centers, 93 (81%) answered a self-administered questionnaire based on the Decision Regret Scale (DRS). RESULTS: Mean DRS score was 16.8 (standard deviation=15.9); 43.0% of participants expressed mild regret, and 25.8% expressed moderate to strong regret. A quarter of the women (25.6%) said that the decision was taken by the doctor alone, and 13.5% said it was not consistent with their own wishes. In the multivariate ordinal regression analysis, an involuntarily passive role in decision making was found to be associated with greater regret (cumulative proportional odds ratio=7.3, 95% confidence interval=2.0-27.6), regardless of age and being allotted or not to the standard treatment in the RCT. CONCLUSION: Whether patients' regret depended on their level of participation in the decision making or vice versa could not be determined in this cross-sectional survey, but efforts should be made to ensure that patients' participation in trials is always based on an active personal decision.