NEW YORK (Reuters Health) - Clinical trial participants are interested in how the trials turn out, results of a small pilot study suggest.

Although many researchers think that study participants should be informed of trial results, this is often not the case (see Reuters Health report, April 20, 2004).

"Potential negative emotional effect on participants, participants' difficulty in understanding results, and concern about consumption of resources, including money and clinician time" are the biggest barriers to informing patients of clinical trial outcomes, lead author Dr. Ann H. Partridge told Reuters Health.

In the current study, Dr. Partridge at the Dana-Farber Cancer Institute in Boston and colleagues offered to inform patients who had participated in a phase II trial of breast excision alone for treatment of ductal carcinoma in situ. Out of 135 participants, 117 wanted to learn the results.

The authors then surveyed 94 of the subjects. They report their findings in the March 12th issue of The Lancet.

Women who were better educated were more likely to want results. Fifty-seven of 85 who wanted the results were college graduates, versus 2 of 9 who chose not to receive the results (p = 0.006). Seventy-one subjects found the lay summary explaining the study findings easy to understand.

The authors also found that 7% were "much more concerned" about the possibility that they would develop breast cancer in the future, while 10 expressed that they were "somewhat more concerned."

Other survey findings indicated that 90 were glad to have been offered trial results, 81 of those who learned results did not regret their decision, and 66 would recommend participation in a clinical trial to others.

"The bottom line," Dr. Partridge said, is that "while there was some increased anxiety among those who learned the results, overall the patients were glad to have been offered the results even if they did not decide to receive them."

She sees this process as a means to "increase communication, improve relationships between patients and doctors, and expand patients' trust in the system."

Lancet 2005;365:963-964

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