Journal Article

Communicating BRCA research results to patients enrolled in international clinical trials: lessons learnt from the AGO-OVAR 16 study

John K. Chan, Peter Vuylsteke, Mansoor Raza Mirza, Michael Friedlander, Catherine Barrett, G. Elser, David J. Pulford, Jose Angel Arranz, Nicoletta Donadello, Charles J. Cox, Chun Fang Xu, Martin Imhof, Anne Floquet, Dominique Berton-Rigaud, Myong Cheol Lim, Thomas J. Herzog, Pauline Wimberger, Toby Johnson, Dong Hoon Suh, Kosei Hasegawa, Giovanni Scambia, Andreas du Bois, Hiroomi Tada, Philipp Harter, Paula Calvert

2016

Overview

Background The 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. Methods An 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. Results Communicating 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. Conclusion This 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 registration This study was registered in the NCT Clinical Trial Registry under NCT00866697 on March 19, 2009, following approval from participating ethics committees (Additional file 1 ).

• Publisher: Springer Science and Business Media LLC,BioMed Central,BioMed Central Ltd,Springer Nature B.V
• Subject: Access to Information / Analysis / Bioethics / Bioethics; BRCA mutation; Incidental finding; Ovarian cancer; Pharmacogenetic research; Health (social science); Issues, Ethics and Legal Aspects; Health Policy / BRCA mutation / BRCA mutations / BRCA1 Protein / BRCA1 Protein - genetics / Disclosure / Disclosure - ethics / Education / Ethics / Ethics in Biomedical Research / Female / Genetic aspects / Health Policy / Health(social science) / Humans / Incidental finding / Informed Consent / Informed consent (Medical law) / Issues, ethics and legal aspects / Mutation / Ovarian cancer / Ovarian Neoplasms / Ovarian Neoplasms - diagnosis / Ovarian Neoplasms - genetics / Patient Preference / Pharmacogenetic research / Philosophy / Philosophy of Medicine / Prognosis / Research Article / Research ethics / Studies / Theory of Medicine/Bioethics