Offering participants results of a clinical trial: sharing results of a negative study

• Published in: The Lancet (British edition) 2005-03, Vol.365 (9463), p.963-964
• Main Authors: Partridge, Ann H, Wong, Julia S, Knudsen, Katherine, Gelman, Rebecca, Sampson, Ebonie, Gadd, Michele, Bishop, Karyn L, Harris, Jay R, Winer, Eric P
• Format: Article
• Language: English
• Subjects: Attitude to Health; Bioethics; Biological and medical sciences; Breast Neoplasms - psychology; Breast Neoplasms - therapy; Breasts; Clinical outcomes; Clinical trials; Clinical Trials as Topic - psychology; Comparative analysis; Disclosure; Educational Status; Female; General aspects; Humans; Medical research; Medical sciences; Middle Aged; Research Subjects - psychology
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(05)71085-0

In general, patients are not given information about the results of trials in which they have participated. We aimed to assess the process and effect of providing clinical trial participants with results of a negative study. We offered results to 135 participants in a phase II trial of breast excision alone for women with ductal carcinoma in situ, which was stopped early because of an early high rate of local recurrence. 85 (90%) of 94 respondents chose to receive results; these women were more educated (57 [67%] of 85 college graduates) than those who chose not to (two [22%] of nine, p=0·006). Most participants reported positive feelings about being offered results and about clinical trials in general. These preliminary findings from sharing clinical trial results are encouraging.