Partridge Ann H, Hackett Nadia, Blood Emily, Gelman Rebecca, Joffe Steven, Bauer-Wu Susan, Knudsen Katherine, Emmons Karen, Collyar Deborah, Schilsky Richard L, Winer Eric P
Dana-Farber Cancer Institute, Boston, MA 02115, USA.
J Natl Cancer Inst. 2004 Apr 21;96(8):629-32. doi: 10.1093/jnci/djh096.
Despite recent interest on the part of advocates and researchers of oncology clinical trials in sharing study results, participants in these trials are not routinely informed about the results. We identified oncology physicians and nurses through the Cancer and Leukemia Group B database and surveyed them about sharing clinical trial results with participants. Of 1977 eligible members, 796 (40.3%) responded to the mailed survey, 497 (62.4%) of whom reported that they offer trial results to participants less than one-fifth of the time. A total of 576 (72.4%) of responders believed that most patients want to know the results of studies, and 634 (79.7%) of responders expressed willingness to offer results to most study participants in the future, believing that most patients want to know trial results and that routinely offering results would not have a negative effect on patients. Concerns of some responders about routinely offering trial results included negative emotional effect on patients, patient difficulty understanding the information, and resources required to offer the results. Of concern, 16.2% (129/796) of responders believed an obligation to offer results to study participants would make them less likely to enroll patients on studies. Future studies should consider sharing trial results with patients and evaluating the process and its effect on both patients and clinicians.
尽管肿瘤学临床试验的倡导者和研究人员最近对分享研究结果颇感兴趣,但这些试验的参与者却并未被常规告知试验结果。我们通过癌症与白血病B组数据库识别出肿瘤内科医生和护士,并就与参与者分享临床试验结果的情况对他们进行了调查。在1977名符合条件的成员中,796人(40.3%)回复了邮寄的调查问卷,其中497人(62.4%)报告称,他们向参与者提供试验结果的次数不到五分之一。共有576名(72.4%)回复者认为大多数患者想知道研究结果,634名(79.7%)回复者表示未来愿意向大多数研究参与者提供结果,他们认为大多数患者想知道试验结果,且常规提供结果不会对患者产生负面影响。一些回复者对常规提供试验结果的担忧包括对患者产生负面情绪影响、患者难以理解信息以及提供结果所需的资源。令人担忧的是,16.2%(129/796)的回复者认为,向研究参与者提供结果的义务会使他们招募患者参与研究的可能性降低。未来的研究应考虑与患者分享试验结果,并评估这一过程及其对患者和临床医生的影响。