2012

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

Clinical Trials, 2012;9(1):90-3.

Mancini J, Genre D, Dalenc F, Maylevin F, Martin AL, Viens P, Julian-Reynier C.

 

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.

 

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