Oncology Physician and Nurse Practices and Attitudes Regarding Offering Clinical Trial Results To Study Participants

Abstract

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.

How do patients want to learn of results of clinical trials? A survey of 1431 breast cancer patients

“…Two further studies (Partridge et al, 2004(Partridge et al, , 2005 both show that the majority of cancer patients would like to receive results, but provide conflicting data on whether patients want results conveyed by their doctor or they are comfortable receiving them by post. For trials with survival as an endpoint, the issue of how, when and whether to disseminate results to the next of kin of those who have died has not been fully explored.…”

Disclosure of Research Results from Cancer Genomic Studies: State of the Science

“…2 The above scenario, although currently rare, is likely to increase in frequency as researchers worldwide generate data and gain access to a growing resource of large specimen banks and linked databases containing genotypic and phenotypic profiles in diseased and healthy populations (e.g., dbGAP, caBIG, PharmGkb). 3 Access to this information, coupled with the expansion of efficient and reliable tools at lower costs, such as whole genome sequencing, will offer unparalleled potential to integrate vast amounts of information to understand etiology, progression, and treatment of cancer. Some information revealed in these efforts will have substantial health or clinical value.…”

Researcher Practices on Returning Genetic Research Results

“…Any combination of these factors may increase the obligation or duty of care to return research results, although these factors are not unique to medical researchers. Previous studies indicated that a substantial proportion of health professionals involved in research supported returning results to participants (Garcia, 1987;Fernandez et al, 2003;Partridge et al, 2004).…”

“…Despite the attention given to this issue, to our knowledge, few data have been collected regarding the prevalence of returning research results, although some studies suggest that the practice is uncommon (Partridge et al, 2004;Rigby and Fernandez, 2005;Shalowitz and Miller, 2008). To provide insight on the practices of genetic and genomic researchers regarding disclosure of research results to participants, we conducted an online survey of authors of genetics and genomics articles published in 2006 and 2007.…”