| Affiliation: | 1.GlaxoSmithKline Medicines Research Centre,Stevenage,UK;2.AGO Study group and Department of Gynecology & Gynecologic Oncology,Kliniken Essen Mitte (KEM),Essen,Germany;3.GINECO and Medical Oncology, Institut Bergonié,Bordeaux,France;4.GSK Stockley Park West,Uxbridge,UK;5.Department of Obstetrics & Gynecology,KGOG and Seoul National University Bundang Hospital,Seongnam-si,Korea;6.ANZGOG and The Prince of Wales Clinical School University of New South Wales,Randwick,Australia;7.GEICO and Hospital General Universitario Gregorio Mara?ón,Madrid,Spain;8.JGOG and Saitama Medical University International Medical Center,Hidaka,Japan;9.GlaxoSmithKline Research and Development,Philadelphia,USA;10.BGOG and Medical Oncology, Université Catholique de Louvain,CHU UCL Namur,Belgium;11.NSGO and Rigshospitalet,Copenhagen,Denmark;12.MaNGO and Ospedale Filippo del Ponte,Varese,Italy;13.Department of Woman Health,MITO and Catholic University of the Sacred Heart,Rome,Italy;14.Palo Alto Medical Foundation,San Francisco,USA;15.Karl Landsteiner Research Institute and Department of Obstetrics and Gynecology,General Public Teaching Hospital, Korneuburg,Vienna,Austria;16.NYGOG and University of Cincinnati Cancer Institute,Cincinnati,USA;17.Cancer Trials Ireland,Dublin 2,Ireland;18.AGO Germany and Department of Gynecology and Obstetrics, TU Dresden,Carl-Gustav-Carus University,Dresden,Germany;19.GINECO and ICO Centre René Gauducheau,Saint-Herblain,France;20.KGOG, Gynecologic Cancer Branch and Center for Uterine Cancer,National Cancer Center,Goyang,Korea;21.AGO Study Group,Wiesbaden,Germany;22.Immuno-Oncology Development, Incyte Corporation,Wilmington,USA |
| Abstract: | BackgroundThe focus on translational research in clinical trials has the potential to generate clinically relevant genetic data that could have importance to patients. This raises challenging questions about communicating relevant genetic research results to individual patients.MethodsAn exploratory pharmacogenetic analysis was conducted in the international ovarian cancer phase III trial, AGO-OVAR 16, which found that patients with clinically important germ-line BRCA1/2 mutations had improved progression-free survival prognosis. Mechanisms to communicate BRCA results were evaluated, because these findings may be beneficial to patients and their families.ResultsCommunicating individual BRCA results was not anticipated during clinical trial design. Consequently, options were not available for patients to indicate their preference for receiving their individual results when they signed pharmacogenetic informed consent. Differences in local requirements, clinical practice, and opinion regarding the ethical aspects of how to convey genetic results to patients are all potential barriers to returning individual BRCA results to patients. Communicating the aggregate BRCA result from this study provided clinical investigators with a mechanism to disseminate the overall study finding to patients while taking individual circumstances, local guidelines and clinical practice into account.ConclusionThis study illustrates the importance of increasing the clarity and scope of informed consent and the need for patient engagement to ensure clinical trial participants can indicate their preference regarding receipt of potentially important individual pharmacogenetic results.Trial registrationThis study was registered in the NCT Clinical Trial Registry under NCT00866697 on March 19, 2009, following approval from participating ethics committees (Additional file 1). |
